A Pilot Study of Emotion Regulation Therapy for Generalized Anxiety and Depression: Findings From a Diverse Sample of Young Adults

    A pilot study of Emotion Regulation Therapy for generalized anxiety and depression: Findings from a diverse sample of young adults Megan E. Renna, Jean M. Quintero, Ariella Soffer, Martin Pino, Leslie Ader, David M. Fresco, Douglas S. Mennin PII: DOI: Reference:

S0005-7894(17)30097-7 doi:10.1016/j.beth.2017.09.001 BETH 743

To appear in:

Behavior Therapy

Received date: Accepted date:

10 March 2017 1 September 2017

Please cite this article as: Renna, M.E., Quintero, J.M., Soffer, A., Pino, M., Ader, L., Fresco, D.M. & Mennin, D.S., A pilot study of Emotion Regulation Therapy for generalized anxiety and depression: Findings from a diverse sample of young adults, Behavior Therapy (2017), doi:10.1016/j.beth.2017.09.001

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RUNNING HEAD: ERT in a diverse sample of young adults

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A pilot study of Emotion Regulation Therapy for generalized anxiety and depression: Findings from a diverse sample of young adults

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Megan E. Renna1, Jean M. Quintero1, Ariella Soffer2, Martin Pino2, Leslie Ader2, David M. Fresco3,4, & Douglas S. Mennin1 1

Teacher’s College, Columbia University, New York, NY Hunter College, City University of New York, New York, NY 3 Kent State University, Kent, OH 4 Case Western Reserve University School of Medicine, Cleveland, OH

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Correspondence regarding this manuscript can be directed to Douglas S. Mennin, Ph.D., Department of Psychology, Teacher’s College, Columbia University, 525 W 120th Street, New York, NY 10027, USA. Tel: 212-772-5567, [email protected].

Funding: This work was supported by the City University of New York Collaborative Incentive Research Grant (CIRG) grant # 2054 and the PSC-CUNY Enhanced Research Award (grant # 65797-00 43. David M. Fresco was supported by National Heart, Lung, and Blood Institute Grant R01HL119977 and National Institute of Nursing Research Grant P30NR015326. Disclosure Statement The authors declare that they have no conflict of interest.

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Abstract Emotion Regulation Therapy (ERT) for generalized anxiety (GAD) and accompanying

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depression (MDD) is a theoretically-derived, evidence based, treatment that integrates principles

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from traditional and contemporary cognitive-behavioral and experiential approaches with basic and translational findings from affect science to offer a blueprint for improving intervention by

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focusing on the motivational responses and corresponding self-referential regulatory

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characteristics. Preliminary evidence supports the efficacy of a 20-session version of ERT. However, previous trials of ERT and other traditional and contemporary cognitive-behavioral

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therapies (CBTs) have often utilized relatively homogeneous samples. Various contextual and demographic factors may be associated with challenges that increase risk for negative mental and

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social outcomes for young adults aged 18-29, particularly for individuals from diverse backgrounds. The aim of this pilot study was to examine the effectiveness of a briefer 16-session

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version of ERT in a racially and ethnically diverse sample of young adults. Participants (N = 31) were enrolled at an urban-based, commuter, college who consented to treatment for anxiety, worry, or depression at an on-campus counseling center. Open trial results demonstrate strong ameliorative changes in worry, rumination, self-reported and clinician rated GAD and MDD severity, social disability, quality of life, attentional flexibility, decentering/distancing, reappraisal, trait mindfulness, and negative emotionality from pre- to post-treatment. These gains were maintained throughout a 3- and 9-month follow-up. These findings provide preliminary evidence for the efficacy of ERT in treating a racially and ethnically heterogeneous population. Further, this study highlights comparable effectiveness of a briefer 16-session version of ERT.

Keywords: generalized anxiety disorder; major depressive disorder; emotion regulation; mindfulness; clinical trial

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A pilot study of Emotion Regulation Therapy for generalized anxiety and depression: Findings from a diverse sample of young adults

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The challenge of distress disorders Generalized anxiety disorder (GAD) is characterized by chronic and excessive worry

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(American Psychiatric Association [APA], 2013), a high degree of subjective distress, and

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considerable functional impairment (Barrera & Norton, 2009). GAD is the most frequently seen psychological disorder in primary care facilities in the United States (Greenberg et al., 1999) and

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the world (Kessler, Walters, & Wittchen, 2004). GAD is even more burdensome when it co-

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occurs with major depressive disorder (MDD). Due to high levels of comorbidity and overlapping symptom presentations, GAD and MDD are often referred collectively as the

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“distress disorders” (e.g.,Watson, 2005). Much of our understanding of the phenomena

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associated with GAD follows from the work of Borkovec (e.g., Borkovec et al., 2002) who

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posited that worry serves an avoidance function. More recently, conceptualizations of worry show that it becomes reinforced by increasing the predictability of negative emotional experience, often to the cost of experiencing greater variations in positive and rewarding states (Newman & Llera, 2011). Considerable evidence supports this functional view of worry at neurobiological (Etkin, Prater, Hoeft, Menon, & Schatzberg, 2010), psychophysiological (Oathes, Siegel, & Ray, 2011; Weinberg, Klein, & Hajcak, 2012), behavioral (Cooper, Miranda, & Mennin, 2013), and self-report (Mennin, Heimberg, Turk, & Fresco, 2005; Roemer, Salters, Raffa, & Orsillo, 2005) levels of analysis. In addition, perspectives on GAD complementary to this functional perspective have emphasized processes such as intolerance of uncertainty (Deschenes, Dugas, Radomsky, & Buhr, 2010); emotional nonacceptance (Roemer et. al, 2005); and emotion dysregulation (Mennin et. al, 2005) factors that increase worry. Although these approaches have advanced our understanding of GAD there exists considerable conceptual

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heterogeneity. One way to potentially integrate and synthesize these approaches is to apply an affect science perspective so as to offer a framework that accounts for the compensatory

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functions of worry and other destructive forms of self-referentiality (e.g., rumination; Mennin &

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Fresco, 2013). Emotion Regulation Therapy

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GAD and MDD, especially when comorbid, are significantly less responsive to treatment

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in the long-term than other anxiety and mood disorders and overall have inferior long-term treatment outcomes (e.g., Newman, Przeworski, Fisher, & Borkovec, 2010). More conventional

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treatment approaches such as cognitive behavioral therapy (CBT), which rely primarily on cognitively elaborative, verbally mediated treatment components (i.e., cognitive restructuring),

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are effective in reducing GAD severity (Cuijpers, Sijbrandij, Koole, Huibers, Berking, & Andersson, 2014) and demonstrate moderate effects during the acute phase of treatment and

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throughout follow-up. More recent mindfulness-based interventions that rely on less-elaborative components (i.e., attentional bias and dysregulation) have demonstrated modest treatment gains as well (Hoge et al., 2013). However, the emergence of more contemporary and comprehensive interventions (i.e., acceptance-based behavior therapy [ABBT], metacognitive therapy) that target less elaborative and more elaborative components within the same treatment package have demonstrated considerably larger effect sizes compared to less comprehensive approaches during the acute period of treatment as well as throughout follow-up (Hayes-Skelton, Roemer, & Orsillo, 2013; Wells et. al, 2010). Emotion Regulation Therapy (ERT) has been developed with the goal of better integrating less and more elaborative treatment components into a comprehensive intervention that is mechanism-targeted. ERT draws from an affect science framework specifically designed

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to address the negative emotionality and self-referencing associated with generalized anxiety and co-occurring depression (Mennin, Fresco, Ritter, & Heimberg, 2015). ERT melds principles

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from traditional and contemporary cognitive behavioral treatments (e.g., Mennin, Ellard, Fresco,

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& Gross, 2013) with basic and translational findings from affect science to identify and intervene on core disruptions of normative motivational, emotional, and cognitive systems. This model

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posits that dysfunction in disorders such as GAD can best be understood by 1) motivational

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mechanisms, reflecting the functional and directional properties of an emotional response tendency; (2) regulatory mechanisms, reflecting the alteration of emotional response trajectories

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utilizing less and more elaborative systems; and (3) contextual learning consequences, reflecting the promotion of broad and flexible behavioral repertoires (Renna, Quintero, Fresco, & Mennin,

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2017). With respect to GAD, dysfunction results from a failure in each of these normative systems of functioning. Using a motivational framework (i.e., identifying reward and risk based

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impetuses), ERT instructs individuals with distress disorders to engage in mindful emotion regulation skills to counteract negative self-referentiality (e.g., worry, rumination, and selfcriticism) in service of pursing rewarding and goal-directed actions in their lives. ERT therapists utilize a case conceptualization approach (e.g., Persons, Fresco, & Ernst, in press) to address negative self-referentiality within the contexts that are most relevant for each client. This approach allows ERT to target specific stressors and conceptual challenges for each individual client while still remaining within the treatment framework. Prior open trial findings of ERT, using a 20 session format, demonstrated efficacy in reducing symptoms of anxiety and depression as well as decreasing worry, increasing quality of life, and improving social disability from pre to post treatment, with gains maintained throughout a 3- and 9-month follow-up period (Mennin et al., 2015). ERT also resulted in model-related

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gains, including greater decentering, cognitive reappraisal, and trait mindfulness as well as reduced negative emotionality and overall emotion regulation deficits (Mennin et. al, 2015) with

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gains maintained throughout follow-up (Hedge’s g’s = .52 to 3.90). A randomized controlled

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trial with a minimum attention control comparator demonstrated that ERT patients evidenced significantly greater reductions in GAD and MDD severity, worry, trait anxiety, and depression

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symptoms, and corresponding improvements in functionality and quality of life with gains

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maintained for nine months following treatment (Hedges g’s = .48 to 1.50; Mennin, Fresco, Heimberg, & O’Toole, under review). Although encouraging, a possible limitation, as with many

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GAD trials, was the absence of racial and ethnic diversity. Thus, an important next step is determining ERT’s generalizability, particularly for subgroups (e.g., racial/ethnical minority

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groups) most at-risk (e.g., young adults) and who have unmet mental health needs. Distress disorders in young adults

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Emerging adulthood, considered to comprise ages 18-29 (Arnett Žukauskienė, & Sugimura, 2014), represents a period of development with many significant life transitions, as well as the beginning of autonomy. Uncertainty often accompanies these major life transitions and may contribute to the high prevalence of depression and anxiety in emerging adults (14.4% to 16.8%; Wittchen, Nelson, & Lachner, 1998). The majority of individuals who will experience bouts of diagnosable anxiety and depression exhibit symptoms of the disorders in young adulthood, often prior to age 22 (Kessler et al., 2005). One factor potentially contributing to the challenges of emerging adulthood is the young person’s underdeveloped emotion regulation abilities (Weinberg & Klonsky, 2009). Mental health problems commonly experienced by young adults are associated with reduced educational advancements, increased substance abuse and violence, and poor reproductive and sexual health (Patel, Flisher, Hetrick, & McGorry, 2007).

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Within US college counseling centers, 58.4% of students endorse anxiety (American College Health Association, 2016), underscoring the importance of identifying the best ways to approach

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and treat anxiety and mood issues within this unique at-risk population.

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Distress disorders in racial and ethnic minorities

With non-white individuals making up more than one third of residents in the United

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States (U.S. Census Bureau, 2012), it is imperative to better understand the contextual factors

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that may contribute to the onset of anxiety and mood disorders within these populations. Indeed, minority subgroups living in the U.S. (i.e., Asian, Hispanic, Afro-Caribbean, Black), especially

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when confronted with discrimination and immigrant status, experience relatively higher rates of GAD compared to majority individuals (Budhwani, Hearld, & Chavez-Yenter, 2015). An

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important goal in providing treatment for these individuals is to benchmark how well existing interventions treat people of different racial and ethnic groups. To date, few intervention studies

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of GAD have utilized diverse samples. One notable exception is Markell et al. (2014) who examined comparative treatment response of CBT versus venlafaxine XR in African Americans compared to European Americans and found similar responses to these treatments in the two racial groups. Although the research examining distress disorders in the context of diverse populations is sparse, it is posited that interventions such as ERT and other contemporary, evidence based, interventions (i.e., ABBT) may be effective in treating these populations due to their focus on values and conceptualization based treatment (Fuchs, Lee, Roemer, & Orsillo, 2013; Persons et al., in press), which allows for the integration of contextual challenges that are unique to each individual. Specifically, the use in these approaches of person-driven and valuesbased frameworks provides an opportunity to individualize treatment and actively address cultural considerations and important contextual challenges to improve culturally sensitive

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conceptualizations and, ultimately, provide more effacious treatment for individuals with anxiety and depression from racial and ethnic minority backgrounds.

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The current study

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Given the profound challenges of emerging adulthood and the barriers facing culturally diverse subgroups in attaining efficacious mental health care, the aim of the current study was to

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replicate and extend the efficacy of ERT and benchmark the ability of ERT to treat a diverse

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sample of young adults diagnosed with GAD (with and without MDD) in an open-trial format. We hypothesized that ERT would significantly reduce symptoms associated with anxiety,

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depression, and social disability, increase quality of life, and demonstrate an ameliorative effect on model related outcomes, including attentional control, emotional distancing, reappraisal,

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emotion dysregulation, and mindfulness. A secondary aim of the current study was to examine the efficacy of a shortened version of ERT (16 versus previously reported 20 session version;

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Mennin et. al, 2015; Mennin et al., under review) to see if this abbreviated length would still yield an optimal treatment response.

Participants

Method

Participants (N = 31) were students currently enrolled at a large, urban, and diverse university in the northeastern United States who consented to therapy and all associated research procedures. Participants were recruited through direct referrals from an on-campus counseling center, fliers posted throughout campus, e-mail announcements, and through research staff handing out business cards on campus. Twenty-eight of 31 participants completed the full 16 weeks of ERT. See Figure 1 for the TREND diagram (Des Jarlais, Lyles, & Crepaz, 2004) for recruitment and retention throughout the trial. Eligibility was limited to students between 18-29

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years old. Participants were also required to speak and understand English and provide informed consent for participation in the study. Due to a separate component of the study involving fMRI,

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eligible participants were not permitted to have any metal in their body, tattoos above their

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elbow, and were excluded if they were currently pregnant or planning to become pregnant during their participation in the study. Participants were required to be stabilized on any psychotropic

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medications for at least three months prior to the start of treatment. Finally, participants could

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not be enrolled in any other form of psychological treatment during the acute phase of ERT (16 weeks) and had to be free of active suicidal intent or plan, psychosis, bipolar I disorder, anorexia

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or bulimia nervosa, somatoform disorders, or substance and alcohol dependence. The main inclusion criterion for the trial was the presence of a GAD diagnosis (primary

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or secondary). Other comorbid mood and anxiety disorders were permitted, with the exception of bipolar I disorder. Of the 31 participants in the study, 71.00% (n = 22) had a primary diagnosis

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of GAD, 25.81% (n = 8) had a co-primary diagnosis of GAD, and 3.23% (n = 1) had GAD as a secondary diagnosis. Co-primary MDD was present in 19.35% (n = 6) of participants, while 6.45% (n = 2) had a co-primary diagnosis of social anxiety disorder. In terms of non-primary diagnostic comorbidity, 54.84% (n = 17) of the sample met full criteria for MDD and an additional 18% (n = 7) met subthreshold criteria for MDD in addition to GAD. Diagnostic and clinical assessment Current and lifetime diagnostic history was determined with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID; First, Spitzer, Gibbon, & Williams, 2002). Each diagnosis reaching clinical or subclinical thresholds was also assigned a clinical severity rating (CSR) score from zero to eight, based on criteria outlined in and adapted from the Anxiety Disorders Interview Schedule for DSM-IV (ADIS; DiNardo, Brown, & Barlow, 1994).

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Diagnostic criteria at the subclinical threshold for a given disorder are reflected by a CSR less than four. A CSR of four or above indicates that all criteria for a diagnosis were endorsed at the

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clinical threshold, with higher scores indicating greater severity. Interviewers were trained to

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assign these scores as per ADIS guidelines based on number and frequency of symptoms endorsed, while also taking into account related levels of distress and impairment attributed to

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the disorder symptomatology. A principal investigator and an independent assessor, both of

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whom were blind to the participant’s diagnoses and CSRs prior to the intake interview, then confirmed participants’ diagnoses and severity ratings. Any discrepancies in CSR ratings

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between the SCID interviewer and principal investigator were resolved through discussion and consensus. Independent assessors conducted separate interviews with all participants to confirm

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these diagnoses, while the principal investigator confirmed diagnoses via consensus meetings with the SCID interviewer where contextual and symptom-related information was provided.

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Diagnostic reliability between the SCID interviewer and independent assessor for GAD was high, with kappa ratings ranging from .71 - 1.00 demonstrating good to excellent reliability. In addition to the assignment of CSR scores, independent assessors also completed the Clinical Global Impression Rating Scale for clinical improvement (CGI–I; Guy, 1976), which was completed at all lab-based assessment visits except for pre-treatment. This permitted the indexing and tracking of changes in improvement as reflected in the current assessment period (compared to pre-treatment). Scores on this scales ranged from 1-7, with a score of 3 or lower indicating change (i.e., 3 = minimally improved, 2 = moderately improved, 1 = markedly improved). Previous research has demonstrated the utility of CGI-I in assessing symptom improvement and its reliable change consistent with corresponding severity scales (Zaider, Heimberg, Fresco, Schneier, & Liebowitz, 2003).

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The research staff, comprised of graduate students and senior research assistants, was trained over several months on the diagnostic assessment protocol. This training involved

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didactic training in psychopathological phenomenology and diagnostics, including issues such as

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comorbidity and differential diagnosis. Interviewers being trained were required to demonstrate strong inter-rater reliability on at least two interviews with a more experienced interviewer

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before conducting assessments independently, as indicated by 100% diagnostic agreement and

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CSR scores within one point of one another. If interviewers failed to demonstrate this level of reliability after two interviews, additional interviews were completed until reliability was met.

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Treatment

ERT consisted of 16 sessions delivered within a maximum period of 20 weeks. Sessions

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occurred on a weekly basis, each lasting for 60 minutes with the exception of sessions 10-13, which last for 90 minutes (i.e., exposure sessions, see below). The first half of the treatment

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focused on psychoeducation and cultivating mindful emotion regulation skills. During these first eight sessions, participants learn mindful attention and metacognitive regulation skills. Attention regulation includes the ability to orient (i.e., the ability to focus and broaden attention) and to allow (i.e. the ability to sustain attention) difficult emotional exteroceptive and interoceptive stimuli. Metacognitive regulation includes skills of distancing/decentering (i.e., the ability for an individual to de-individuate from motivations and corresponding feelings and thoughts, or to notice that one is not synonymous with one’s essential self) and reframing emotional experiences and contexts (i.e. the ability to change one’s evaluation of an event so as to alter its emotional significance). The second half of treatment involves developing a proactive approach towards meaningfully rewarding activities despite perceived risks. This is accomplished through the use

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of imaginal exposure and experiential dialogue tasks. More information regarding the structure and specific components of ERT are described elsewhere (see Mennin & Fresco, 2014).

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Clinicians consisted of 12 doctoral students in clinical psychology trained to administer

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treatment protocol by DMF and DSM and received two hours of supervision on a weekly basis. To establish adherence to the treatment protocol, all treatment sessions were audio recorded, and

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research assistants coded all 16 sessions from 40% of all cases, with 25% of these cases coded by

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two coders to establish inter-reliability. Reliability rates between the coders was 100%. Coders rated the frequency (0 = therapist did not address component/engage action, 1 = therapist

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addressed component/engaged action, 2 = therapist addressed component/engaged action in more detail) and skillfulness (0 = therapist was not skillful or performed poorly, 1 = therapist

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performed action adequetly, 2 = therapist performed action very skillfully) of therapist actions consistent with the different skills and concepts outlined in the ERT manual. Total ratings of

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frequency and skillfulness of therapist actions across the four phases of treatment were separately summed for each case. This sum was then divided by the overall possible points for frequency and skillfulness. Overall, the mean skillfulness rating of the therapists coded was 98.40%, while the mean frequency of actions consistent with the treatment protocol was 91.20%. Self-reported anxiety and depression outcome measures The State Trait Anxiety Inventory (STAI-7). The STAI-7 (Bieling, Antony, & Swinson, 1998) is a seven-item measure of trait-level anxiety (e.g., nervousness, worry, and tension). Internal consistency of the STAI-7 was moderate at pre-treatment (Cronbach’s  =.64). The Beck Depression Inventory-II (BDI-II). The BDI-II (Beck, Steer, & Brown, 1996) is a 21-item questionnaire measure widely used to assess depressive symptoms over the past two weeks. Internal consistency of the BDI-II was strong at pre-treatment ( =.86).

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The Mood and Anxiety Symptom Questionnaire-Short Form (MASQ). The MASQ (Watson & Clark, 1991) is a 62 item measure assessing anxiety and depression symptoms. The

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four factors are derived from the MASQ represent: General Distress Anxiety (MASQ–GDA), Anxious Arousal (MASQ–AA), General Distress Depression (MASQ–GDD), and, Anhedonic

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Depression (MASQ–AD). Cronbach’s alpha for the MASQ subscales in the current study ranged from moderate to strong at pre-treatment (’s = .61 to .91).

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Perseverative thought outcome measures

The Penn State Worry Questionnaire (PSWQ). The PSWQ (Meyer, Miller, Metzger,

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& Borkovec, 1990) is widely used 16-item self-report measure of pathological worry. In the current study Cronbach’s alpha for the PSWQ at pre-treatment was strong at .80.

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The Brooding subscale of Rumination Scale (RS). The RS (Armey, Fresco, Moore, Mennin, Turk, & Heimberg, 2009; Treynor, Gonzalez, & Nolen-Hoeksema, 2003) is a five-item

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measure of self-reported rumination uncontaminated with depression symptom content. Internal consistency for the RS in the current study was moderate at .63. The Perseverative Thinking Questionnaire (PTQ). The PTQ (Ehring, Zetsche, Weidacker, Wahl, Schonfeld, & Ehlers, 2011) is a 15-item measure of self-reported repetitive negative thinking which assesses several debilitating aspects of perseveration, including the repetitiveness, intrusiveness, and disengagement difficulties. Internal consistency in the current study at pre-treatment was strong (=.86). Functioning and quality of life outcome measures The Quality of Life Inventory (QOLI). The QOLI (Frisch, Cornell, Villanueva, & Retzlaff, 1992) is a self-report measure of global well-being along multiple life domains (such as

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relationships, environment, work, and play) assessing importance and satisfaction in each of the 16 domains. Internal consistency in the current study was adequate at pre-treatment (= .76).

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The Sheehan Disability Scale (SDS). The SDS (Sheehan, 1983) assesses level of

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disability within the domains of work/school, social life, and family life/home responsibilities,

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with the underlying notion that disability may partially mediate the relationship between symptoms and quality of life and overall functioning. As indicated in previous research

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(Hambrick, Turk, Heimberg, Schneier, & Liebowitz, 2004), the Cronbach’s alpha for the SDS is typically low. However, the measure does show greater internal consistency when a factor

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analytic approach is applied (Leon, Olfson, Portera, Farber, & Sheehan, 1997). Consistent with previous research, the Cronbach’s alpha for the three item SDS in the current study at pre-

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treatment was low at .38.

ERT model-related outcome measures

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The Attentional Control Scale (ACS). The ACS (Derryberry & Reed, 2002) is a 20item measure that assesses the degree to which an individual is able to both shift and sustain their attention. Higher total scores indicate greater ability to control of one’s attention. Internal consistency in the current study at pre-treatment was strong ( = .85). The Experiences Questionnaire-Decentering subscale (EQ-D). The EQ-D (Fresco et al., 2007) is a 20-item measure assessing the meta-cognitive strategy of decentering, or viewing oneself as separate from their emotional experience, with higher scores indicating a greater ability to utilize this skill. In the current study the, internal consistency at pre-treatment was strong (= .80).

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The Emotion Regulation Questionnaire - Reappraisal subscale (ERQ-R). The ERQR (Gross & John, 2003) is a six-item measure of cognitive reappraisal that demonstrated strong

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internal consistency in the current study at pre-treatment (=.86).

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The Affect Intensity Measure–Negative Intensity subscale (AIM-NI). The AIM-NI

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(Larsen, 1985) is a self-report measure that assesses emotional reactions to different events that an individual may encounter in their lives. The current study specifically utilized the Negative

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Intensity subscale, consisting of 10 items, that assesses the characteristic strength or weakness of intense negative emotional responses (i.e., emotionality). Internal consistency at pre-treatment

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was moderate at .65.

The Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ (Baer, Smith,

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Hopkins, Krietemeyer, & Toney, 2006) is a 39-item self-report measure of trait-mindfulness.

good (= .86).

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Higher scores indicate greater trait mindfulness. In the current study, internal consistency was

The Difficulties in Emotion Regulation Scale (DERS). The DERS (Gratz & Roemer, 2004) is a 36-item measure assessing different aspects of emotion dysregulation. In the current study used the DERS total score, which demonstrated strong internal consistency at pretreatment (= .88). Procedure The Institutional Review Board of the college approved all procedures. After providing written informed consent, participants completed an initial intake assessment, which involved the SCID interview and a battery of self-report questionnaires. Prior to the start of treatment, participants completed an independent assessment, which included clinician-administered personally relevant SCID modules based upon intake (i.e., a CSR > 3) with an interviewer blind

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to details from the initial intake interview. Following session 8 (i.e., mid-treatment), participants returned to the lab to complete another independent assessment and self-report questionnaires.

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Following session 16, participants again returned to the lab to complete these activities. An

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assessment visit identical to these was also completed three months and nine months posttreatment. Participants completed a functional magnetic resolution imaging (fMRI) scan directly

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before and after treatment. Results from the fMRI assessment are reported elsewhere.

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Participants were compensated for all assessment visits. Analytic Plan

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A power analysis using G*Power software indicated a sample size of 31 participants was able to detect a medium effect size (.5 or above) with 80% power. All analyses utilized last

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observation carried forward (LOCF), and therefore all visits following the participant’s mid-lab visit were carried forward if a participant dropped out or were lost to follow-up. Missing data

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across participants for all timepoints was minimal ( < 10%). All measures were scored so long as 80% or more of the individual responses were provided for a particular measure. We readily admit that LOCF has been controversial because one of the key assumptions is that participants do not change over time and missing data rarely satisfy definitions for missing at random (e.g., Houck et a., 2004). Consequently, LOCF may result in an underestimate of the true treatment effects during the acute treatment phase. In some instances, LOCF may overstate treatment durability where clinical deterioration is highly likely in a follow-up period (e.g., Alzheimer’s Disease, European Medicines Agency [EMA], 2011) but is less likely to overstate effect sizes with respect to emotional disorders such as depression (EMA, 2011) . Despite these potential limitations, even critics concede that LOCF represents a transparent, straight-forward way of

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handling missing data, and likely reflects a conservative lower range estimate of true treatment effects (e.g., Houck et al., 2004).

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Study outcomes were grouped into five different categories: Diagnostic Outcomes (GAD

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CSR, MDD CSR, mean CSR of additional anxiety disorders1); Self-Reported Anxiety (STAI-7, MASQ-GDA, MASQ-AA); Self-Reported Depression (BDI-II, MASQ-GDD, MASQ-AD);

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Perseverative Thought (PSWQ, RS, PTQ); Quality Of Life/Functioning (QOLI, SDS); and ERT

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Model-Related Measures (ACS, EQ-D, ERQ-R, AIM-NI, FFMQ, DERS). To examine changes throughout ERT, paired-sample t-tests were conducted using IBM SPSS version 21 comparing

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pre-treatment to: mid-treatment, post-treatment, 3-month follow-up, and 9-month follow-up. To reduce the likelihood of Type I errors due to multiple comparisons, a Bonferroni correction was

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used for each family of analysis (i.e., number of outcome variables in each group multiplied by the number of timepoints), which resulted in only reporting significance as follows: p < .003 for

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Diagnostic Outcomes; p < .004 for Self-Reported Anxiety Outcomes, Self-Reported Depression Outcomes, and Perseverative Thought Outcomes; p < .006 for Quality of Life/Functioning Outcomes; and p <.002 for ERT Model-Related Outcomes. All t statistics were converted to Hedge’s g effect size index, interpreted with conventions of Small = .20, Medium = .50, Large = .80. To examine treatment outcome for race and ethnicity, we conducted a series of repeated measure ANOVAs with race (white versus non-white) or ethnicity (Hispanic versus NonHispanic) as between subject factors and a primary measure from each outcome family (i.e., GAD CSR, PSWQ, STAI-7, BDI, QOLI, DERS) at each timepoint as the within-subject

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Comorbidity between GAD and other anxiety disorders was also high, with 51.61% (n = 16) meeting diagnostic criteria for at least one additional anxiety disorder. In terms of specific anxiety disorder comorbidity at pretreatment, 19.35% (n = 6) endorsed panic disorder, 32.26% (n = 10) social anxiety disorder, 6.45% (n = 2) PTSD, 3.23% (n = 1) OCD, and 12.90% (n = 4) specific phobia.

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variables. Primary variables were chosen based on centrality in prior GAD trial research including our own RCT of ERT (Mennin et al., under review).

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Clinically significant change and high end-state functioning were examined in four ways.

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Simple clinical response was assessed as diagnostic severity of GAD and MDD reduced below clinical threshold (CSR < 4; CGI-I < 3). Two more stringent indices of clinical significance

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were derived from procedures used by Borkovec, Newman, Lytle, and Pincus (2002) and

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Ladouceur et al. (2002) and commonly utilized by other GAD trials (e.g., Borkovec & Costello, 2003; Roemer & Orsillo, 2007; Hayes-Skelton et. al, 2013). This approach represents a more

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conservative estimate of clinically meaningful change as compared to the reliable change index which assesses whether one or more clinical indicators achieve greater than two standardized

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units of change (z > 1.96; e.g., Jacobson & Truax, 1991). Thus, participants were regarded as GAD responders by evidencing a clinically meaningful response on at least four of six GAD

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indices: (GAD CSR < 4, CGI-I < 3, at least 30% improvement on the PSWQ, STAI-7, MASQAA, & MASQ-GDA). Similarly, patients were regarded as MDD responders if they evidenced a clinically meaningful response on at least four of six MDD indices (MDD CSR < 4, MDD CGI-I < 3, at least 30% improvement on the BDI-II, MASQ-AD, MASQ-GDD, & RS). Also, high endstate functioning was derived by assessing whether patients fell into the normative range (within one standard deviation of healthy norms on published clinical measures, e.g., Ladouceur et al., 2002) on at least four of six GAD measures (GAD CSR < 4, CGI-I < 3, PSWQ, STAI-7, MASQ-AA, & MASQ-GDA) and four of six MDD measures (MDD CSR < 4, MDD-I < 3, BDIII, MASQ-AD, MASQ-GDD, & RS). Consistent with a LOCF approach, clinical significance during the acute treatment phase of the trial was assessed as a ratio of the number of responders over the total number of patients

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enrolled in the acute phase (N = 31). Given that missing data were minimal at follow-up, an LOCF approach was employed by carrying forward post-acute treatment data into the 3-month

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follow-up assessment point (n = 4) and 9-month follow-up assessment point (n = 6). Results

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Sample demographics

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Participants’ mean age was 22.25 years old (SD = 2.48). The sample was predominantly female (n = 22, 70.97%), which is consistent with community norms of GAD (McLean, Asnaani,

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Litz, & Hofmann, 2011). The sample also demonstrated racial, ethnic, and sociodemographic

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diversity. 29.03% of the participants self-identified their ethnicity as Hispanic. Self-reported race for this sample was: 45.16% White, 6.45% African American, 19.35% Asian American or

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Pacific Islanders, 9.68% as mixed race, and 3.23% as other, and 16.13% of the sample self-

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identified their race as Hispanic/Latino2,3. Over one-third (38.71%) self-reported being either

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bilingual or fluent in a language other than English and 19.35% of participants were born outside of the US. In terms of income, 30.43% of the sample reported that their household (i.e., family) income fell below $25,000 annually, 30.43% reported a household income between $25,000 and $49,999, and 13.04% between $50,000 and $74,999. Twenty-six percent of participants did not know their annual household income or chose not to answer this question. Regarding parental education, approximately one third of the sample reported that their parents’ educational

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Although the designation of Hispanic/Latino is not traditionally included or officially recognized in race identification categories according to the U.S. Census, these individuals are oftentimes involuntarily lumped into the ‘other’ category. In service of recognizing and appreciating the full range of racial and ethnic identities we chose to uphold the Hispanic/Latino racial designation in an effort to preserve the strong cultural attachment that some individuals have in identifying their race in this manner (Pew Research Center, 2015), rather than being limited to these census reporting standards. 3 Participants were representative of the larger academic community from which they were recruited. The academic institution where the study took place consists of 36% White students, 22% Hispanic/Latino, 10% Black or African American, 24% Asian/Pacific Islander, 1% mixed race, and 7% qualified as ‘other’. The current sample is well representative of the borough of Queens, where the majority of participants lived. The 2010 census report demonstrated that, of those living in Queens, approximately 40% identified as White, 28% Hispanic/Latino, 23% Asian/Pacific Islander, and 19% African American.

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attainment was a high school diploma or less (Fathers = 37.50%; Mothers = 33.33%). Twentyfive percent of participants’ fathers received an associate’s or bachelor’s degree while 33.33% of

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mothers reported this level of education. Approximately one quarter of their parent’s attained an advanced degree (i.e., master’s degree or above; Fathers = 20.83%; Mothers = 25.00%) while

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some participants did not know their mother’s (8.33%) and father’s (16.67%) highest education

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level.

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Medication usage was also assessed at all time points. At pre-treatment, only one participant enrolled in the trial while prescribed a stable, low dose antidepressant medication. No

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participants reported being on psychiatric medication between post-treatment and the 3-month follow-up and two reported being on such medications at the 9-month follow-up. No participants

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endorsed initiating additional psychotherapy between post-treatment and the 3-month follow-up, and two participants reported entering into psychotherapy between the 3-month and 9-month

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follow-ups. Given the low rates of medication usage and the absence of any additional psychotherapy following acute treatment, these variables were not controlled for in analyses. Effects of treatment on clinical outcomes Means and standard deviations for clinical outcomes (e.g., diagnosis, self-reported anxiety and depression symptoms, perseverative thought, disability and quality of life, model related outcomes) are included in Table 1. Table 2 provides test statistics and effects sizes for all analyses. Overall, results demonstrate significant reductions on all measures with effect sizes exceeding conventions for large effects. Clinical significance analyses Results of the clinical significance analyses are presented in Table 3.

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GAD. Over half the sample evidenced GAD CSR reductions that fell below clinical significance at post treatment, with this percentage increasing through the 3- and 9-month

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follow-up. Further, over 80% of participants received CGI-I scores below clinical threshold at

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post treatment, with these percentages only falling slightly at the 3-month and 9-month follow-up periods. Using a more stringent criterion where participants had to make at least 30%

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improvement in at least four out of six anxiety-related self-report or clinical outcome measures,

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over 80% of participants achieved this level of improvement at post treatment, and falling only slightly throughout the follow-up periods. Finally, when our aforementioned operational

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definition of high end-state functioning for GAD, over half of patients achieved this stringent definition of treatment success at post-treatment (58.06%) and at 3-month follow-up (64.29%)

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with a modest dip at the 9-month follow-up (57.14%). MDD. Participants with MDD, overall, showed a substantial reduction in CSR scores at

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post treatment with these results strengthening over the 3- and 9-month follow-up. Further, 73.68% of participants demonstrated moderate or marked improvement at post-treatment, with this number decreasing to 50.00% at the 3-month follow-up. At the 9-month follow-up, 66.67% of participants demonstrated moderate or marked improvement of MDD symptoms. When evaluating 30% change on at least 4 of 6 measures of depression, 68.42% of participants at posttreatment and 66.67% at 3-month follow-up demonstrated substantial improvement using this criterion. However, this percentage increased to 77.78% at the 9-month follow-up. Using more stringent criteria to assess post-acute and long-term improvements in MDD symptoms, 73.68% of participants at post treatment, 66.67% at 3-month follow-up, and 55.56% at 9-month followup achieved or maintained high end-state functioning. Exploratory analyses assessing effects of race and ethnicity on clinical outcomes

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Exploratory analyses were conducted to examine differences in treatment outcome by race (White [n = 14] versus Non-White [n = 17]) and ethnicity (Hispanic [n = 9] versus Non-

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Hispanic [n = 22]). Results demonstrated a significant race*time interaction for BDI (F[1,28] =

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2.77, p = .05) and DERS (F[1,28] = 3.66, p = .02) scores throughout treatment for non-white participants compared to white participants. Non-White participants endorsed higher BDI scores

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at the start of treatment (M = 30.31, SD = 8.04) than White individuals (M = 23.64, SD = 9.34).

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Interestingly, depression scores dropped lower for Non-White participants (M = 5.25, SD = 4.57) than White participants (M = 10.64, SD = 7.97) at post-treatment, which was maintained at the

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3- and 9-month follow-up. This pattern was consistent for the DERS as well, with Non-White participants demonstrating greater emotion dysregulation at pre-treatment (M = 104.33, SD =

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19.24) compared to White participants (M = 101.00, SD = 17.73), with scores falling lower at post-treatment for Non-White participants (M = 69.27, SD = 16.88) compared to the White

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group (92.50, SD = 23.80). The difference in this gain was maintained at the 3- and 9-month follow-up. There were no significant race*time interactions for GAD CSR (p = .29), STAI-7 (p = .47), PSWQ (p = .41), or QOLI (p = .21). Similarly, there were no significant ethnicity*time interactions for any of the principle outcome measures. While STAI-7 (p = .93), BDI (p = .09), PSWQ (p = .37), QOLI (p = .23), and DERS (p = .42) scores did not approach significance, GAD CSR (p = .06) trended towards significance, demonstrating marginally significant differences in GAD severity between Hispanic and Non-Hispanic participants across timepoints. Discussion The present study replicates prior trials indicating that ERT is efficacious and welltolerated as indicated by low rates of drop-out throughout treatment. Findings also extend these prior results by showing comparably strong effects for an abbreviated version of ERT (i.e., 16

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sessions) in reducing both GAD and MDD symptoms, worry, rumination, and social disability as well as improving quality of life in a sample of ethnically diverse young adults suffering from

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anxiety and mood disorders. Further, these improvements were maintained at 3- and 9-month

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follow-up periods. Additionally, participants showed gains from pre- to post-treatment and through the 9-month follow-up in model-related general outcomes including negative

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emotionality, emotion regulation, and mindfulness as well as more specific ERT-related skills

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training targets including shifting and sustaining attention, distancing/decentering, and reappraising (Mennin & Fresco, 2013). The effectiveness of this briefer version of ERT may

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promote greater dissemination of the intervention, particularly in settings where treatment may be time limited or for those of whom seeking long-term care is cost prohibitive.

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Overall, these findings join the growing body of research demonstrating improved ability to treat GAD with and without comorbid MDD via more comprehensive treatment packages.

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Meta-analytic investigations find traditional CBT approaches to GAD to be efficacious in the short-term (Cuijpers et. al, 2014). Although these effect sizes are strong for worry, the cardinal feature of GAD (Covin, Ouimet, Seeds, & Dozois, 2008), there is less evidence that associated symptoms and conditions such as MDD are fully ameliorated, especially in the longer term (Newman et al., 2010). Further, traditional CBT approaches have produced only moderate success in bringing individuals with GAD to a symptomatic level congruent with normative functioning (i.e., high endstate functioning; Borkovec et. al, 2002). CBTs integrating newer conceptualizations such as acceptance/mindfulness and an emotional/interpersonal focus have improved treatment gains throughout acute and follow-up periods, especially in demonstrating improved indices of high endstate functioning (i.e., symptomatic response within one standard deviation of normative levels; e.g., Roemer et al., 2009; Newman et al., 2011). ERT trials

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provide evidence for strengthening for traditional GAD outcomes (e.g., anxiety and worry) as well as MDD and associated processes. Indeed, ERT demonstrates large, sustained effects in

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GAD and MDD outcomes as well as in worry and rumination equivalent or superior to prior

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GAD trials. Further, ERT patients evidence high endstate functioning in anxiety and depression outcomes (e.g., between 71%-85% for GAD and 57%-80% high endstate functioning at 9-month

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follow-up; Mennin et al., 2015, under review). Clinical significance indicators of treatment gains

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at post-treatment in the current study were comparable to the prior ERT trials as well as other GAD treatments incorporating acceptance/mindfulness and emotion-related components (e.g.,

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Roemer & Orsillo, 2007). One notable exception was that high end-state functioning for GAD dropped to 57% at the 9-month follow-up.

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Findings from the current study highlight the need for interventions that are both efficacious and tolerable for young adults, a group that is particularly at risk of suffering from

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anxiety and mood difficulties while also characterized by a decreased likelihood of seeking treatment. Although the incidence of GAD tends to increase throughout adulthood (Beesdo, Pine, Lieb, & Wittchen, 2010), it is important to understand the ways in which the symptoms associated with this disorder impact young adults as well as the ways to best intervene for this younger demographic. Stigma associated with seeking treatment may in fact prevent young adults from seeking psychological services (Eisenberg, Golberstein, & Gollust, 2007). Indeed, in a nationwide epidemiological sample of people aged 15-54, young adults (defined as age 18-24) had the most negative views of seeking treatment than any other age group (Gonzalez, Alegria, & Prihoda, 2005). Further, demand for services within college-based counseling centers are often high, and resources are sometimes low, so not all individuals are able to access the care available there (Watkins, Hunt, & Eisenberg, 2012).

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Non-white racial minority groups may also experience boundaries not faced by white counterparts, contributing to their reduced willingness to seek treatment. This may include

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beliefs about treatment that may impact treatment adherence and subsequent outcomes, stigma

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associated with seeking care, and poor quality and lack of specialization of mental health care (Schraufnagel, Wagner, Miranda, & Roy-Byrne, 2006). Research has also shown stigma

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associated with mental health care, socioeconomic hardships, and lack of specialized care as

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three potential risk factors for non-white Americans not seeking treatment (Kouyoumdjian, Zamboanga, & Hansen, 2003). Findings of the current study extend the efficacy of ERT by

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utilizing a diverse racial, ethnic, and socioeconomic sample. Subgroup analyses revealed no significant time*ethnicity interactions in principle outcomes across treatment for Hispanic vs.

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Non-Hispanic ethnicities. In terms of race, findings indicated significant group differences across treatment for BDI and DERS scores. Interestingly, we found that Non-White participants

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demonstrated greater improvements in emotion regulation abilities and greater reductions in depressive symptoms throughout treatment compared to White participants. Although these subgroup analyses yielded relatively small sample sizes and results are preliminary, these findings highlight that ERT was successful overall in treating a heterogeneous group of individuals.

Although ERT was not explicity tailored to different races and ethnicities, the use of a case conceptualization approach allowed therapists to target contextual stressors that may present barriers to successful treatment. Consistent with the approach presented by Fuchs and colleagues (2013) of mindfulness- and acceptance-based interventions, ERT provides a framework for understanding clients’ distress-related struggles within a narrative and framework that is individualized and addreseses contextual and cultural considerations that may impact how the

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anxiety and/or depression is expressed and discussed (i.e., wanting a specific career path but having family with an opposing idea; desiring a healthy lifestyle but experiencing financial

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limitations regarding the types of changes they are able to make; for a more thorough review of

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this process, see Renna et al., 2017). This approach provides a preliminary, yet important step in understanding best approaches to treating diverse individuals with ERT. Future research should

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continue to expand upon these findings by tailoring interventions in a way that best meets the

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need of this large subset of the population.

This study has several limitations that should be noted. The current study utilized an open

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trial design. Given that study recruitment occurred through a university counseling center, staff were concerned about the inclusion of a waitlist control as it may have delayed or prevented

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students from accessing treatment. In addition, the small sample size prevented a more nuanced subgroup analysis. Although we were able to examine differences in treatment outcome based on

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race (White versus Non-White) and ethnicity (Hispanic versus Non-Hispanic), the ethnic groups were relatively uneven which may have influenced analysis. While the racial groups were more evenly distributed in the subgroup analysis, the categorization of White versus Non-White did not permit us to examine more nuanced differences between different Non-White racial groups in terms of treatment outcome. Utilizing a larger sample would also allow us to determine characteristics that may help to better hone and personalize ERT to those with varying contexts and cultural experiences. Although a strength this study was the inclusion of economically, racially, and ethnically diverse participants, the barriers to treatment that such patients often face may not fully apply since these individuals were provided with free mental health care at the oncampus counseling center. Further, a large percentage (17%) of clinically eligible participants were not enrolled because of the fMRI exclusions and only 38% of all potential participants were

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deemed eligible and enrolled in the study, thus further limiting generalizability of the current findings. Finally, several outcome variables demonstrated low reliability (i.e., SDS, STAI, RS,

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MASQ, and AIM) and therefore should be interpreted with caution. The low relabilitity of these

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measures highlight the necessesity to better understand their psychometric properties in diverse samples.

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Despite the consistent efficacy findings for ERT, an important area of future research will

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be to determine which components of ERT are most responsible for producing treatment gains. The demonstrated improvements in model-related outcomes also suggest potential targets for

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determining mechanism of change that align closely with basic emotion science and affective neuroscience research and theory. Indeed, recent evidence supports model components such as

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decentering as mediators of clinical outcome (Mennin et al., under review). In addition, recent investigations have provided preliminary support for behavioral and biological indicators of

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attentional (Renna et al., under review) and meta-cognitive indices (Fresco et al., 2017; Raab et al., under review) accounting for clinical outcome. However, further research is needed to determine if these changes in proposed mechanisms truly account for clinical change. These findings highlight the importance of conducting trial research on sociodemographically heterogeneous and treatment refractory populations. Future studies are needed to determine if the effects found in this study would generalize to individuals who are not readily diagnosed with GAD or MDD given stigma around diagnosis often found in some age and ethnic subgroups. Current trials are testing ERT transdiagnostically as research has demonstrated that core components of distress disorders such as worry and rumination exist across the diagnostic spectrum (Mennin & Fresco, 2013). Despite the need for these future steps, findings from the current study further support the preliminary efficacy of a novel approach for

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treating distress disorders in an effort to promote stronger long-term ameliorative changes for

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diverse young adults suffering from these conditions.

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Table 1 Means and standard deviations of outcome measures Measure Pre-Tx Mid-Tx Post-Tx

9-month

4.83 (1.18) 2.50 (1.60) 3.32 (1.54)

3.48 (.96) 2.14 (1.61) 2.98 (1.51)

3.23 (1.02) 1.95 (1.76) 2.72 (1.43)

3.10 (1.04) 1.50 (1.65) 2.57 (1.48)

Anxiety Outcomes STAI-7 19.81 (3.29) MASQ-GDA 32.23 (7.01) MASQ-AA 35.27 (13.00)

15.57 (3.57) 23.20 (4.85) 26.43 (8.95)

13.55 (4.11) 20.90 (5.64) 24.37 (7.65)

13.52 (3.85) 22.07 (6.11) 24.00 (8.02)

14.00 (3.87) 23.03 (7.24) 25.65 (7.77)

Depression Outcomes BDI-II 26.71 (9.41) MASQ-GDD 42.37 (8.11) MASQ-AD 78.14 (12.10)

13.93 (8.87) 28.43 (10.06) 64.27 (14.97)

8.03 (6.88) 23.87 (8.97) 59.77 (13.17)

9.65 (7.88) 25.69 (11.29) 64.04 (14.19)

10.35 (7.42) 27.42 (10.25) 64.00 (14.80)

Perseverative Thought Outcomes PSWQ 69.13 (7.25) RS 14.90 (2.70) PTQ 41.85 (7.40)

59.17 (10.65) 11.97 (3.47) 31.21 (10.27)

50.97 (12.16) 10.58 (3.67) 26.29 (12.37)

51.71 (11.77) 10.39 (3.66) 26.05 (12.76)

52.06 (11.32) 10.61 (3.64) 27.27 (10.60)

Quality of Life/Functioning Outcomes SDS 18.81 (4.66) 15.07 (6.36) QOLI -0.28 (1.43) 0.51 (1.74)

12.16 (7.64) 1.29 (1.54)

11.55 (6.21) 1.21 (1.50)

11.68 (6.08) 0.90 (1.52)

Model-Related Outcomes FFMQ 104.34 (16.43) DERS 101.97 (17.08) EQ-D 26.17 (6.25) ERQ-R 20.77 (7.77) AIM-NI 25.77 (4.85) ACS 43.30 (8.21)

129.37 (21.71) 82.13 (23.01) 39.03 (8.30) 29.58 (7.52) 21.19 (5.16) 50.04 (8.23)

124.77 (23.06) 81.19 (19.74) 38.43 (8.45) 28.97 (7.31) 20.39 (5.81) 49.46 (10.30)

123.16 (24.14) 84.07 (21.43) 36.00 (8.07) 28.00 (6.18) 21.97 (6.62) 49.19 (9.65)

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Diagnostic Outcomes GAD CSR 5.71 (.78) MDD CSR 4.91 (.97) ANX CSR 4.03 (.91)

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3-month

120.79 (21.59) 90.54 (23.81) 35.50 (9.64) 26.77 (8.48) 22.83 (5.53) 47.60 (7.70)

Note. Pre-Tx = Pre treatment, Mid-Tx = Mid treatment, Post-Tx = Post treatment, 3-month = 3-month follow-up, 9-month = 9-month follow-up, GAD CSR = Clinical Severity Rating for GAD, MDD CSR = Clinical Severity Rating for MDD, ANX CSR = Additional anxiety disorder mean CSR, STAI-7 = State Trait Anxiety Inventory, MASQ GDA = Mood and Anxiety Symptoms Questionnaire General Distress Anxiety subscale, MASQ AA = Mood and Anxiety Symptoms Questionnaire Anxious Arousal subscale, BDI-II = Beck Depression Inventory second edition, MASQ GDD = Mood and Anxiety Symptoms Questionnaire General Distress Depression subscale, MASQ AD = Mood and Anxiety Symptoms Questionnaire Anhedonic Depression subscale, PSWQ = Penn State Worry Questionnaire, RS = Rumination Scale, PTQ = Perseverative Thinking Questionnaire, SDS = Sheehan Disability Scale, QOLI = Quality of Life Inventory, FFMQ = Five Facet Mindfulness Questionnaire, DERS = Difficulties with Emotion Regulation Scale, EQ-D = Experiences Questionnaire Decentering subscale, ERQ-R = Emotion Regulation Questionnaire Reappraisal subscale, AIM NI = Affect Intensity Measure, Negative Intensity subscale, ACS = Attentional Control Scale.

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t

g

t

Diagnostic Outcomes GAD CSR MDD CSR ANX CSR

4.45* 5.85* 2.57

1.62 2.49 1.18

11.27* 6.61* 3.30*

Anxiety Outcomes STAI-7 MASQ-AA MASQ-GDA

5.21* 4.26* 7.12*

1.90 1.61 2.69

Depression Outcomes BDI-II MASQ-AD MASQ-GDD

5.65* 3.95* 5.64*

Perseverative Thought Outcomes PSWQ 4.90* RS 4.07* PTQ 4.73*

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Table 2. T-scores and effect sizes of outcome variables Pre to 3-mo. Follow-up t g

Pre to 9-mo. Follow-up t g

12.04* 7.48* 4.77*

4.32 3.27 2.25

11.24* 9.72* 4.81*

4.04 4.15 2.27

6.72* 4.91* 7.26*

2.42 1.82 2.70

6.97* 7.02* 6.61*

2.50 2.61 2.45

6.95* 4.01* 6.18*

2.50 1.49 2.30

2.06 1.52 2.13

8.27* 4.99* 7.29*

2.97 1.89 2.71

9.11* 4.22* 5.80*

3.27 1.62 2.15

9.15* 4.41* 6.01*

3.29 1.67 2.23

1.79 1.49 1.93

7.78* 5.19* 5.90*

2.79 1.89 2.36

8.92* 6.66* 5.50*

3.21 2.39 2.16

7.88* 5.42* 6.26*

2.83 1.95 2.45

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4.05 2.82 1.56

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Pre to Post t

1.07 1.13

4.79* 4.03*

ERT Model Related Outcomes EQ-D 4.83* ERQ-R 3.22 FFMQ 3.82* DERS 2.42 AIM-NI 3.80* ACS 2.25

1.79 1.18 1.42 0.92 1.39 1.03

7.11* 5.10* 5.88* 4.69* 5.19* 4.21*

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Pre to 9-mo. Follow-up t g

5.02* 5.58*

1.81 2.01

3.77* 6.03*

1.26 2.17

2.60 1.83 2.11 1.68 1.87 1.65

6.98* 4.60* 4.21* 4.77* 5.26* 3.66*

2.55 1.65 1.51 1.72 1.89 1.44

6.09* 4.86* 3.77* 3.63* 3.93* 3.31

2.22 1.75 1.35 1.33 1.31 1.30

1.72 1.45

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t Disability/Quality of Life Outcomes QOLI 2.93* SDS 3.09*

Pre to 3-mo. Follow-up t g

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Table 2 (Continued). T-scores and effect sizes of outcome variables

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Number of treatment responders (and % LOCF sample size) using conventional indices of clinical significance 3-Month Follow-up # Responders

9-month Follow-up # Responders

16/31 (51.61%)

19/28 (67.86%)

19/28 (67.86%)

25/31 (80.65%)

22/28 (78.57%)

20/28 (71.43%)

25/31 (80.65%)

21/28 (75.00%)

22/28 (78.57%)

18/31 (58.06%)

18/28 (64.29%)

16/28 (57.14%)

13/19 (68.42%)

14/18 (77.78%)

14/19 (73.68%)

9/18 (50.00%)

12/18 (66.67%)

30% Improvement (4+ of 6 Criteria Met)

13/19 (68.42%)

12/18 (66.67%)

14/18 (77.78%)

High Endstate Functioning (4+ of 6 Criteria Met)

14/19 (73.68%)

12/18 (66.67%)

10/18 (55.56%)

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Post-Acute Treatment # Responders

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GAD Clinical Response ADIS GAD CSR < 4

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CGI-Improvement < 3 30% Improvement (4+ of 6 Criteria Met)

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ADIS MDD CSR < 4 CGI-Improvement < 3

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MDD Clinical Response

15/18 (83.33%)

Note. ADIS GAD CSR = Anxiety Disorders Interview Schedule GAD Clinical Severity Rating, CGI-Improvement = Clinical Global Impression Improvement Scale, ADIS MDD CSR = Anxiety Disorders Interview Schedule MDD Clinical Severity Rating.

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Figure 1.

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Prospective ERT Participants (n = 82)

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Trend data

Completed 9month follow-up (n = 26)b

a

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Completed 3month follow-up (n = 27)a

Dropped out (n = 3)

Could not contact (n = 7) Not interested (n = 10) No GAD diagnosis (n = 10) Could not undergo fMRI (n = 14) Scheduling issues (n = 4) Not between ages 18-29 (n = 3) Unknown (n = 3)

Lost to 3-month follow-up (n = 2)

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Completed ERT (n = 28)

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Did not enroll in ERT (n = 51)

Enrolled in ERT (n = 31)

Lost to 9-month follow-up (n = 3)

One participant who dropped out during the acute phase of treatment completed the 3-month follow-up. One participant who dropped out during the acute phase of treatment completed the 9-month follow-up.

b

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Highlights:  ERT has been effective in treating distress disorders  Significant reduction in outcomes throughout open trial of ERT  Diverse young adults show improvements comparable to previous trials of ERT