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    A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence Among Persons Living With HIV/AIDS Charles P. Br...

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    A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence Among Persons Living With HIV/AIDS Charles P. Brandt, Daniel J. Paulus, Monica Garza, Chad Lemaire, Peter J. Norton, Michael J. Zvolensky PII: DOI: Reference:

S1077-7229(17)30029-9 doi:10.1016/j.cbpra.2017.01.007 CBPRA 663

To appear in:

Cognitive and Behavioral Practice

Received date: Accepted date:

31 August 2016 24 January 2017

Please cite this article as: Brandt, C.P., Paulus, D.J., Garza, M., Lemaire, C., Norton, P.J. & Zvolensky, M.J., A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence Among Persons Living With HIV/AIDS, Cognitive and Behavioral Practice (2017), doi:10.1016/j.cbpra.2017.01.007

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ACCEPTED MANUSCRIPT A Novel Integrated Cognitive-Behavioral Therapy for Anxiety and Medication Adherence

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Among Persons Living With HIV/AIDS

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Charles P. Brandt, University of Houston and Baylor College of Medicine

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Daniel J. Paulus, University of Houston Monica Garza and Chad Lemaire, Legacy Community Health

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Peter J. Norton, Monash University

Center

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Michael J. Zvolensky, University of Houston and University of Texas MD Anderson Cancer

The authors do not report any financial, personal, or other conflicts of interest. The current study was funded by Grant F31-0099922 awarded to the first author by the National Institute of Mental Health. Address correspondence to Charles Brandt, Department of Psychology, University of Houston, 126 Heyne Building, Houston, TX, 77204; [email protected].

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Abstract

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Persons living with HIV/AIDS (PLHIV) are able to live full lifespans after infection, however,

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rates of anxiety disorders among this population are elevated compared to national samples. Importantly, these anxiety symptoms and disorders have a negative effect on medication

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adherence, quality of life and other psychological disorders, such as depression. In order to

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reduce the impact of anxiety among PLHIV, a six-session transdiagnostic CBT-based treatment manual for anxiety among PLHIV named the HIV/Anxiety Management-Reduction Treatment

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(HAMRT) was developed and implemented. The current manuscript discusses the content of this manual as well as results from three cases examining the impact of HAMRT. Results indicated

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that HAMRT was effective in reducing symptoms of anxiety, anxiety sensitivity, depression, and negative affect among our sample. Additionally, results indicated that HAMRT was effective in

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increasing HIV medication adherence as well as quality of life. Results are discussed in terms of the potential utility of an anxiety-reduction therapy program aimed at increasing medication adherence among PLHIV.

Keywords: HIV, anxiety, anxiety sensitivity, medication adherence, negative affect

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Human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) affect

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over 32 million people globally and has been proclaimed an international pandemic by the World

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Health Organization (World Health Organization, UNAIDS, UNICEF, 2007). Though recent

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advances in highly active antiretroviral medication (HAART) have enabled infected individuals to live much longer with the disease, medication adherence remains a prevalent problem in this

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population (Bonolo et al., 2005). Poor medication adherence is especially problematic since antiretroviral medications (cART) must be adhered to at a 95% rate to be optimally effective

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(Paterson et al., 2000), and suboptimal adherence can lead to viral drug resistance (Hirsch et al., 1998). Studies have shown that optimal medication adherence leads to higher quality of life

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(O’Cleirigh, Skeer, Mayer, & Safren, 2009), higher CD4 T-cell counts (O’Cleirigh et al., 2009), and lower rates of disease transmission (Fang et al., 2004; Warszawski et al., 2008). Medication

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adherence is particularly poor among persons living with HIV (PLHIV) who are suffering from psychological illnesses (Antoni, 2003). Significant strides in helping PLHIV with problems adhering to HIV medication will likely be found in the ability to develop novel, targeted treatments (Campos et al., 2008). For instance, researchers have started to develop behavioral interventions for medication adherence in PLHIV with depressive symptoms (Daughters, Magidson, Schuster, & Safren, 2010; Safren et al., 2009). Yet, there has not been scientific effort focused on anxiety among PLHIV. Studies have consistently documented a clinically and statistically strong relationship between HIV and increased prevalence of anxiety symptoms and disorders (Els et al., 1999; Morrison et al., 2002). Rates of anxiety disorders among PLHIV range widely but have been estimated as high as 43% (Brandt et al., 2017). Panic disorder and generalized anxiety disorder

ACCEPTED MANUSCRIPT prevalence are consistently elevated among PLHIV relative to nationally representative samples (Brandt et al., 2017).

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Anxiety disorders in particular are associated with poor HIV symptom and medication

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control, compared with those without anxiety disorders (Antoni, 2003). Co-occurring anxiety also is associated with the perception of more severe HIV symptoms (Leserman et al., 2005),

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increased functional impairment, and higher levels of medical care (Leserman et al., 2005).

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Additionally, studies have shown that PLHIV meeting criteria for an anxiety disorder diagnosis have lower levels of medication adherence (Schönnesson, Diamond, Ross, Williams, & Bratt,

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2006; Van Servellen, Chang, Garcia, & Lombardi, 2002). The same type of pattern has been documented for depressive symptoms and disorders, which commonly co-occur with anxiety and

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its disorders (DiMatteo, Lepper, & Croghan, 2000). There are a number of reasons why anxiety and HIV may uniquely influence each other.

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HIV and certain anxiety symptoms (e.g., panic attacks, excessive worry) share in common numerous bodily symptoms (e.g., heart palpitations, nausea, dizziness, chills, sweating, chest pain). In fact, 50–80% of PLHIV experience HIV-specific bodily symptoms similar to anxiety symptoms (Aouizerat et al., 2010). These HIV-related symptoms increase anxiety symptoms (Gonzalez, Zvolensky, Solomon, & Miller, 2010), which in turn can increase HIV symptoms (Huggins, Bonn-Miller, Oser, Sorrell, & Trafton, 2012), creating a cycle of worsening anxiety and HIV symptoms. One common and clinically significant pathway may be the misinterpretation of bodily sensations (i.e., “catastrophic thinking”). For example, antiretroviral medication regimens are complex and produce a number of physiological side effects (e.g., rash, peripheral neuropathy, anemia; Abdella, Wabe, & Yesuf, 2011). A distorted cognitive reaction to such medication-based sensations (e.g., “I cannot tolerate this distress any longer”) can

ACCEPTED MANUSCRIPT theoretically result in poorer medication adherence (Aberg, 2009; Kurtyka, 2010; Volberding & Deeks, 2010)—that is, the individual may stop using his or her medication because he or she is

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hypersensitive to its effects. Anxiety symptoms and disorders may also decrease health-related

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quality of life among PLHIV. For instance, elevated anxiety has been found to be significantly related to fatigue, HIV symptoms (Sewell et al., 2000), and poorer physical functioning in men

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to distinguish between HIV and anxiety symptoms.

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with HIV (Nathan & Gorman, 2015). It is, therefore, important to provide patients with the tools

Given the impact of anxiety among PLHIV, a six-session transdiagnostic CBT-based

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treatment manual for anxiety among PLHIV was developed and implemented. This project aims to build on previous work by creating and testing a novel anxiety-reduction therapy program for

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PLHIV. Although rooted in anxiety reduction, this project also aims to increase HIV medication adherence and examine changes in other important psychological constructs, including

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depression, negative affectivity, and quality of life. This study is the first to integrate treatment/management of HIV with treatment for anxiety problems that impede success of HIV management. This treatment protocol is named the “HIV/anxiety management–reduction treatment” (HAMRT). In the following, we discuss three cases examining the impact of HAMRT.

Method The current study is a three-subject case series study design, and all cases were taken from a larger study examining the feasibility and utility of transdiagnostic anxiety-reduction therapy on HIV medication adherence and anxiety reduction among 60 adults living with HIV/AIDS. These cases were selected as illustrative examples of this treatment protocol. This

ACCEPTED MANUSCRIPT study was approved by the University of Houston IRB, and each participant signed informed consent for participation prior to pretreatment assessment. Participants were recruited from local

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HIV/AIDS service organizations via study flyers in patient waiting rooms, advertisements (e.g.,

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newspaper), and word of mouth. Treatment was advertised as an anxiety-reduction therapy program for HIV+ individuals.

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The therapy protocol, HAMRT, is based on the transdiagnostic model developed by

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Norton (2012) in that traditional cognitive-behavioral therapy (CBT) techniques are used to treat a range of anxiety disorders. This treatment also incorporates elements of Unified Protocol

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developed by Barlow and colleagues (2010) via the inclusion of a transdiagnostic anxiety sensitivity reduction component. In addition to a focus on anxiety symptoms, HIV medication

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adherence was discussed at every session, and tracked as a homework assignment between each session. The treatment included six 50-minute individual sessions of manualized treatment.

Procedures Session 1

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Material covered in each session is as follows.

This session serves as an opportunity for the therapist to discuss anxiety- and HIV-related issues with the patient and build therapeutic rapport. Additionally, Session 1 incorporates an overview of the HAMRT program and therapeutic rationale, psychoeducation about anxiety and emotions, health benefits and side-effects of cART, and an overview of the CBT-based model for HIV and anxiety. Problem solving for HIV medication nonadherence was then discussed, including barriers that may interfere with medication adherence (e.g., forgetting), specific plans to overcome these barriers (e.g., getting a pill box, setting a daily alarm), and enacting these

ACCEPTED MANUSCRIPT plans. The patient is asked to track his or her HIV medication management as well as anxiety

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symptoms and associated impact for homework before Session 2.

Session 2

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This session focuses primarily on cognitive restructuring, termed “Changing My

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Thoughts” in the HAMRT patient manual, in an effort to reduce jargon and make the treatment

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more approachable to community individuals. First, homework was reviewed. If homework was not completed, motivational interviewing was used to increase patient motivation. If homework

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was completed with nonoptimal results (e.g., tracking medications, but missing many doses in the previous week), barriers were addressed and a plan to overcome these barriers was

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developed. Then, the CBT model for HIV and anxiety was discussed. Specifically reviewed are the ways in which HIV and anxiety may impact each other and how anxiety may affect

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interpretations of HIV-elicited arousal symptoms. Then, the patient is led through a discussion of the form and function of unhelpful and negative automatic thoughts. Strategies to challenge and adjust negative automatic thoughts are discussed, and the patient practices disputing negative thoughts with guidance from the therapist. Finally, a fear hierarchy is created, and homework is assigned, including reviewing the hierarchy and completing two cognitive restructuring exercises independently. The fear hierarchy is used to rank triggers (situations, objects, memories, etc.) in terms of how much distress they would elicit on the subjective units of distress scale (SUDS). SUDS ratings range from 0 (no distress) to 100 (maximum possible distress). Participants were encouraged to complete their fear hierarchy, and continue tracking their medication adherence for homework.

ACCEPTED MANUSCRIPT Session 3 This session begins with a review of homework, including problem solving regarding

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difficulties with cognitive restructuring exercises, and a review of the fear hierarchy. During

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Session 3 cognitive restructuring is continued and interoceptive exposure (IE) exercises (physical challenge tasks designed to elicit sensations similar to physical sensations associated with

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anxiety) are introduced. Examples include breathing through coffee stirrers to force short-term

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oxygen deprivation and forced hyperventilation. Such tasks have been shown to consistently reduce rates of anxiety sensitivity (Boswell et al., 2013). A minimum of three IE exercises are

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performed to show the patient that physical symptoms associated with anxiety are normal, okay, to be expected, and will decrease with practice. Homework for this week includes a minimum of

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three at-home practice sessions of IE exercises and tracking of HIV medication compliance.

Session 4

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After Session 3 participants are reassessed to index treatment progress.

This session begins with a review of homework, including problem solving regarding difficulties with HIV medication adherence and IE exposure exercises. Session 4 then recaps the skills learned to date in treatment, and lingering difficulties are discussed. After this, exposure exercises become the main focus of all remaining sessions; these sessions are called “Facing My Fears” in the patient manual. During Session 4, rationale for exposure is discussed and, together, the patient and therapist pick a feared situation from the fear hierarchy and agree to “face the fear.” Exposure selection is done collaboratively, directed by the patient as much as possible. First exposures typically are in the SUDS of 50–60 range to avoid anxiety that may overwhelm the patient. Following selection of an exposure task, cognitive restructuring is performed about

ACCEPTED MANUSCRIPT thoughts occurring during the exposure. Then, the exposure is performed in session. The patient is asked his or her SUDS rating throughout the exposure. Typically, SUDS increase with initial

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exposure, and decrease over time to demonstrate habituation to the exposure. The patient is

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debriefed and congratulated after completion of the first exposure. The patient is then assigned homework of performing his or her own exposure outside of therapy by the next session and

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continued tracking of HIV medication adherence. The homework exposure is typically similar to

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that practiced in session or an extension (i.e., slightly greater SUDS ranking). The aim of this is

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to facilitate habituation and generalization to “real-world” settings.

Session 5

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This session begins with a review of homework and difficulties with exposure exercises or medication are discussed and a plan is created to overcome any barriers. Then another

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exposure exercise is selected to accomplish during the session. For this exposure exercise, the patient takes a more leading role in the selection of the exposure exercises with support/encouragement from the therapist as needed. Participants are debriefed after the insession exposure, and assigned another exposure for homework. Participants are also assigned continued medication adherence tracking as a homework exercise.

Session 6 During Session 6, homework is discussed and a final in-session exposure exercise is conducted. This exposure exercise is selected and led by the patient, and facilitated by the therapist. Afterward, relapse prevention work included a discussion of the importance of continuing to face fear and anxiety, as well as signs of lapse and relapse and strategies for

ACCEPTED MANUSCRIPT continuing progress. A recap of strategies to continue medication adherence is also discussed. At this point, patients complete their posttreatment assessment and are scheduled for their 1-month

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posttreatment follow-up session.

Measures

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The following measures were administered to each patient at a baseline intake

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assessment, midtreatment (after three sessions), posttreatment (after six sessions) and at a 1month posttreatment follow-up session. Mid- and posttreatment measures were completed by

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participants immediately after their therapy sessions, out of sight of their therapist. One-month follow-up measures were administered by a study staff member who did not serve as a therapist

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in the study.

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MINI International Neuropsychiatric Interview (MINI; Sheehan et al., 1997) The MINI is a brief semistructured diagnostic interview, which was developed in order to assess a wide range of DSM-IV-TR-defined psychological disorders (emotional disorders, substance use disorders, psychosis, etc.; American Psychological Association, 2004). The MINI has been utilized in prior studies examining HIV+ samples (e.g., Breuer et al., 2014) and is psychometrically sound (see Sheehan et al., 1997). In the current study, the MINI was assessed at the baseline intake session and 1-month posttreatment follow-up session.

State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983) The STAI is a 40-item self-report questionnaire used to index state (i.e., current) and trait (i.e., average) anxiety levels. Items are rated on a 5-point Likert-type scale ranging from 1

ACCEPTED MANUSCRIPT (almost never) to 4 (almost always). The state (STAI-S) and trait (STAI-T) scales each yield total scores ranging from 20 to 80. The STAI is a reliable and valid measure of state and trait anxiety

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that is commonly employed in anxiety research with clinical and nonclinical populations

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(Spielberger et al., 1983; Zvolensky, Forsyth, Fuse, Feldner, & Leen-Feldner, 2002) as well as PLHIV (Kee et al., 2015). The 20-item STAI-T was used in the current study to assess anxiety,

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transdiagnostically, as has been done in previous trials (Norton et al., 2013). STAI-T scores have

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been previously reported as 36.0 for normative samples (Spielberger et al., 1983) and 52.3 for

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clinical samples (Bieling, Antony, & Swinson, 1998).

Positive and Negative Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988)

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The PANAS is a 20-item scale on which respondents indicate, on a 5-point Likert-type scale from 1 (very slightly or not at all) to 5 (extremely) the degree to which they have felt, in the

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past week, negative or positive affect. The 10-item negative affect subscale (PANAS-NA) was used to index past-week (i.e., trait) negative affect. PANAS-NA scores range from 10 to 50. Past studies have shown that the psychometric properties of the PANAS are acceptable in both anxious and depressive samples (Brown, Chorpita, & Barlow, 1998; Watson et al., 1988) as well as HIV+ samples (e.g., Gonzalez et al., 2010). Normative scores on the PANAS-NA have been reported as 16.0 (Crawford & Henry, 2004) with average scores among clinical outpatients as 29.3 (Paulus, Talkovsky, Heggeness, & Norton, 2015).

Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007) The ASI-3 is an 18-item self-report scale of anxiety sensitivity. The scale yields a total score as well as three subfactors of physical, mental, and social concerns. Respondents rate each

ACCEPTED MANUSCRIPT item (e.g., “When my stomach is upset, I worry that I might be seriously ill”) on a 5-point Likerttype scale from 0 (very little) to 4 (very much). ASI-3 total scores range from 0 to 72. The ASI-3

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has excellent psychometric properties (Taylor et al., 2007) and has indexed good reliability

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among HIV+ samples (Brandt et al., 2017). Normative scores on the ASI-3 have been reported as

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12.8 with clinical average scores of 29.5 (Taylor et al., 2007).

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AIDS Clinical Trials Group Adherence Assessment (ACTG; Chesney et al., 2000) The ACTG was used to measure each patient’s adherence to his or her HIV medication

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regimen. Specifically, each patient was asked by a trained assessor to indicate how many HIV medications are prescribed, how many doses are prescribed per day, and how many doses were

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missed total in the past 2 weeks. This information was used to create a variable indicating

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“percent adherent in the past two weeks.” In order for HIV medications to be optimally effective,

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they must be adhered to at a rate of at least 80% (Viswanathan et al., 2015).

Inventory of Depression and Anxiety Symptoms (IDAS; Watson et al., 2007). The IDAS is a 64-item self-report instrument that assesses various affect symptom dimensions experienced within the past 2 weeks. The IDAS contains 10 specific symptom subscales (suicidality, lassitude, ill-temper, well-being, insomnia, appetite loss, appetite gain, panic, social anxiety, and traumatic intrusions) and two broad subscales (general depression and dysphoria). Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The IDAS subscales show strong internal consistency, convergent and discriminant validity with psychiatric diagnoses and self-report measures, and short-term retest reliability within both community and psychiatric patient samples (Watson et al., 1988, 2007). IDAS

ACCEPTED MANUSCRIPT subscales have shown good to excellent internal consistencies among PLHIV (e.g., Gonzalez, Zvolensky, Parent, Gover, & Hickey, 2012). The current study used the general depression

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subscale (IDAS-Depression; 20 items; e.g., “I felt exhausted”). IDAS-Depression scores range

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from 20 to 100. Watson et al. (2007) reported community average scores of 45.0 with clinical

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average scores of 56.0.

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World Health Organization Quality of Life (WHOQOL-BREF; World Health Organization, 1996)

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The WHOQOL-BREF is a 26-item self-report instrument designed to assess four domains of quality of life (physical health, psychological, social, and environmental) that was

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developed from the original WHO-QOL-100. The WHOQOL-BREF has demonstrated excellent psychometric activities including convergent and discriminant validity (Snell, Siegert, Surgenor,

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Dunn, & Hooper, 2016). The six-item psychological quality-of-life subscale was used in the current study. Each item is rated on a scale from 1 (not at all) to 5 (an extreme amount), summed together, and then transformed to a 0–100 scale; higher scores indicate greater quality of life. The WHOQOL-BREF has been successfully utilized among numerous samples of chronic health conditions including PLHIV (e.g., Chandra, Deepthivarma, Jairam, & Thomas, 2003). Psychological quality-of-life scores on the WHOQOL-BREF have been previously reported as 70.6 for normative samples (Hawthorne, Herrman, & Murphy, 2006) and 12.5 for PLHIV (Fang, Hsiung, Yu, Chen, & Wang, 2002).

Case Study 1 Case Introduction

ACCEPTED MANUSCRIPT Patient 1 was a 50-year-old homosexual Caucasian man presenting with a desire to reduce his anxiety and depressive symptoms. He additionally reported suboptimal HIV

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medication adherence, indicating that his anxiety and depressive symptoms significantly

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interfered with his ability to adhere to these medications.

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History of Presenting Complaints

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Patient 1 reported a series of independent mental health concerns. Specifically, he endorsed current feelings of depression, recurrent panic attacks, social fears, posttraumatic

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symptomology, and previous hypomanic and psychotic symptoms (currently controlled by medication). He also endorsed suicidal thoughts at the time of the intake interview and expressed

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a desire to “feel happy again,” including being able to work consistently and spend more time

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with his friends and nephews. Patient 1 reported dealing with anxiety and depression for “as long

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as I can remember”; however, he reported that his symptoms became worse when his good friend died an AIDS-related death a few years prior. He also reported that he has sought CBT-based therapy services for his anxiety in the past (greater than 1 year prior to the initiation of this program), and that his symptoms reduced during treatment, then returned after treatment termination.

Assessment As per the MINI diagnostic interview, Patient 1 reported frequent recurrent depressive symptoms, including depressed mood, anhedonia, difficulty sleeping, feelings of fatigue and worthless, difficulty concentrating, and suicidal thoughts in the past 2 weeks. He reported that this depression has significantly affected his quality of life, including his ability to work and

ACCEPTED MANUSCRIPT spend time with family and friends. He also reported that he experiences consistent 2-week patterns of depressive symptoms, but has felt okay for 2 weeks or more at a time in the past 2

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years. Patient 1 reported having frequent recurrent panic attacks and that he frequently avoided

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panic-inducing situations (e.g., calling in sick to work, avoiding seeing family) to stave off the attacks. He reported posttraumatic symptoms as a result of seeing his friend die an AIDS-related

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death and that in the past month he experienced reexperiencing symptoms, including intense

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recollections and nightmares. He also reported that in the past month he avoided talking about the event; avoided activities, people, and places that reminded him of the event; became less

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interested in activities; felt detached from others; and felt “numbed.” These symptoms resulted in difficulty sleeping, irritability, difficulty concentrating, and being easily startled. Additionally, he

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reported past hypomanic episodes and psychotic symptoms, including hearing voices, but that his symptoms of hypomania and psychotic symptoms were controlled via medication.

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Given the diverse nature of this patient’s symptoms, he was asked if any one disorder may cause or exacerbate the others (e.g., “Did your experience with your trauma mark the beginning of your panic or depressive symptoms?”). Patient 1 indicated that each of his symptom clusters (major depressive disorder [MDD], panic, posttraumatic stress disorder [PTSD], hypomania) had distinct onset periods, and were not causally related. Additionally, although the patient did meet criteria for bipolar II as per his depression and hypomania, the MINI does not explicitly diagnose any of the bipolar disorders. As such, these symptom clusters are listed separately here, and were addressed in treatment; he was diagnosed with MDD, PTSD, panic disorder with agoraphobia, and a past hypomanic episode. Questionnaire-based assessments corresponded with Patient 1’s diagnoses. At the baseline assessment he scored in the clinical range for anxiety (STAI-T = 65) and depression

ACCEPTED MANUSCRIPT (IDAS-Depression = 73). He also reported moderate negative affect (PANAS-NA = 34) and low levels of psychological quality of life (WHOQOL-BREF-Psychological = 6). Patient 1’s anxiety

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sensitivity was also elevated (35) and he reported missing 50% of his HIV medications in the

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past 2 weeks. See Figure 1 for Patient 1’s information.

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Case Conceptualization

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HAMRT was recommended to treat Patient 1’s MDD, panic disorder with agoraphobia, and PTSD, with a dual focus of increasing his HIV medication adherence. He reported that he

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often missed medications because he forgot, felt depressed, or felt overwhelmed.

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Course of Treatment and Assessment Progress The skills presented in each of the six sessions were presented in the same order as

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indicated in the Method section. Session 1 focused on psychoeducation about anxiety and HIV medication adherence. During this session, Patient 1 discussed reasons for wanting to reduce his anxiety and depressive symptoms, including being able to work more consistently and improving his quality of life—his anxiety and depression significantly interfered with his ability to find pleasure in daily activities. He was able to identify safety behaviors he used to cope with anxiety including avoiding anxiety-provoking situations at almost any cost but expressed concern about his ability to improve with treatment. The short- and long-term benefits of avoidance as a strategy for handling anxiety were discussed, and motivational interviewing techniques were used to facilitate the patient’s engagement in treatment. In Session 2, cognitive restructuring strategies were discussed in order to deal with negative thoughts and feelings in a healthy way. During the session, Patient 1 reported that he

ACCEPTED MANUSCRIPT felt “terrible” and badly did not want to be in session because his anxiety was causing him physical distress. Cognitive restructuring was used to reframe the patient’s thinking pattern from

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“I do not want to be here” to “Being here now will help me to feel better later.” He engaged in

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treatment for the entire session, including multiple cognitive restructuring attempts throughout the session. Homework assignments included daily cognitive restructuring exercises about his

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physical distress, including changing thoughts of “This is unbearable” to “I can handle these

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physical symptoms.” Patient 1 reported completing the homework exercises, and feeling better after practicing thought-changing strategies throughout the week.

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During Session 3, IE exposure exercises were completed. Hyperventilation was used as a safe method of increasing physiological responses similar to the anxiety Patient 1 felt in regard

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to anxiety and depressive symptoms. He was asked to rate the distress experienced by these exercises using a 100-point SUDS. Three exposures were conducted in session, with his SUDS

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reaching a high point of 60, and, by the third exposure exercises, returning to 0 within 1 minute of the exercise. The patient was assigned homework of practicing these exposure exercises daily before the next session.

Sessions 4–6 included in vivo exposure exercises. The exposure in Session 4 focused on Patient 1 checking his e-mail, which he had not checked in weeks because he feared seeing the email address of his friend who had passed away. Session 4 included imaginal exposure of this event, including imagining that he did have multiple e-mails from his friend who had passed away. Once Patient 1 felt as though he could handle this outcome, given that he had practiced in session, homework was assigned to check his e-mail at least once before the next session. Session 5 focused on exposure to things he had been avoiding in the previous weeks, including paying bills and reaching out to friends; these exposures were practiced in session and assigned

ACCEPTED MANUSCRIPT for homework the following week. He completed all assigned homework assignments and reported that these exposures “really helped” him to “get over things that were really bothering

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me.” He reported purposefully having discussions with his friends about his now-deceased friend

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that were “very helpful.” Session 6 served as a recap of the past 2 weeks, including an exposure being outside in public near the therapist’s office. The patient reported that he was enjoying

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exposures (“I’m pushing myself”) and felt anxiety and depressive symptoms much less often.

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During the course of treatment, Patient 1 made marked improvements in anxiety, depression, psychological quality of life, and HIV medication adherence, as well as gains in

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mood and affect, although these were not the primary goals of this program. His trait anxiety (STAI-T = 65 at baseline, 68 at week 3, 47 at termination) fell below the clinical average (52.3;

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Bieling et al., 1998; see Figure 1). Regarding his fear of anxiety-relevant sensations, his ASI-3 total score reduced from baseline (39) to week 3 assessment (26), reducing even further by

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termination (17) below the clinical average (29.5; Taylor et al., 2007). Patient 1’s psychological quality of life was stable from baseline to week 3 (WHOQOL-BREF-Psychological = 6) but improved substantially by termination (44), well above averages reported among PLHIV (12.5; Fang et al., 2002). His past 2-week HIV medication adherence also improved significantly during the course of treatment, and he reported adhering to only 50% of medications at baseline, 79% of medications at week 3 follow-up, and 71% of past 2-week medications at termination. Notably, although depression was not explicitly targeted in any session, Patient 1’s IDASDepression score decreased from 73 at intake to 49 by termination, within 1 standard deviation of the community average (M = 45.0, SD = 14.8; Watson et al., 2007).

Follow-Up

ACCEPTED MANUSCRIPT During the course of the treatment, Patient 1 made marked improvements in anxiety and depressive symptoms, anxiety sensitivity, and HIV medication adherence. He was reassessed 1-

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month posttreatment completion. Generally, the gains made during treatment were maintained at

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this follow-up time point. Specifically, trait anxiety fell below posttreatment levels (STAI-T = 36), as did fear of anxiety-relevant sensations (ASI-3 = 11), and depressive symptoms (IDAS-

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Depression = 32). Quality of life further improved from termination (WHOQOL-BREF-

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Psychological = 44) to follow-up (56). Regarding psychiatric diagnoses, Patient 1 was readministered the MINI at the 1-month follow-up appointment, meeting criteria for a current

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major depressive episode, but not panic disorder or PTSD. Finally, the patient’s medication adherence also improved notably, from 50% adherence at baseline to 71% adherence

Case Study 2

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posttreatment, and 86% adherence at follow-up.

Case Introduction

Patient 2 was a 53-year-old heterosexual African American male presenting with a desire to reduce his anxiety and depressive symptoms. He reported suboptimal HIV medication adherence, indicating that his anxiety and depressive symptoms significantly interfered with his ability to adhere to these medications.

History of Presenting Complaints Patient 2 reported interfering anxiety and depressive symptoms beginning 5 years ago when his wife passed away in an accident and that when he found out about his wife’s death, he responded with intense fear and helplessness, but was not persistently plagued by recurrent

ACCEPTED MANUSCRIPT reexperiencing symptoms of this event. Instead, he reported a depressed mood, and worry about many different aspects of his life, including his health and his relationship with his

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grandchildren, who were not “being taken care of well” by his children. Patient 2 reported being

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HIV positive as well as type 1 diabetic. He reported that his physical illnesses as well as psychological symptoms affected him daily, including impeding his ability to work and enjoy

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time with his girlfriend, children, and grandchildren. He reported using marijuana “a few times a

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week” to help him cope with these symptoms and that he had not sought mental health services

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in the past.

Assessment

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As per the MINI diagnostic interview, Patient 2 reported that he experienced depressive symptoms including feelings of sadness, anhedonia, difficulty sleeping, psychomotor retardation,

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fatigue, feelings of worthlessness, difficulty concentrating, and thoughts of suicide. He reported that he experiences consistent 2-week patterns of depressive symptoms, but has felt okay for 2 weeks or more at a time in the past 2 years. He also reported daily worries that interfered with his normal activities in addition to worries about his health, HIV, his girlfriend’s health and safety, and the well-being of his children and grandchildren. Despite a previous trauma history and weekly marijuana use, Patient 2 did not meet criteria for PTSD or substance abuse/dependence at the baseline assessment. Given the overlap in symptoms of generalized anxiety disorder (GAD) and MDD, the patient was asked to differentiate these symptoms and to indicate whether his symptoms were due to one cause (e.g., worry, depression) more than the other. Patient 2 reported that each of these symptom clusters affected him equally, and that symptoms that overlap both GAD and

ACCEPTED MANUSCRIPT MDD (e.g., insomnia) were exacerbated by both his depression and worry; thus, both diagnoses were warranted.

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Questionnaire-based assessments corresponded with Patient 2’s diagnoses. At baseline

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assessment, the patient scored in the clinical range for anxiety (STAI-T = 56) and indexed moderate negative affect (PANAS-NA = 36). His anxiety sensitivity score was also elevated (39)

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and he reported missing 21% of his HIV medications in the past 2 weeks. See Figure 1 for

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Patient 2’s symptom information. The anxiety sensitivity index was not available for Patient 2 at

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baseline.

Case Conceptualization

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HAMRT was recommended to treat Patient 2’s comorbid GAD and MDD; the treatment had a dual focus on increasing HIV medication adherence. The patient reported that he often

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missed medications because he forgot, was away from home, or ran out of pills. The patient expressed therapeutic goals of enjoying time with his family, and spending less time during the day feeling sad or worried. The therapeutic goal for Patient 2 was to decrease avoidance behavior.

Course of Treatment and Assessment Progress The skills presented in each of the six sessions were presented in the same order as for Patient 1. The first session focused on psychoeducation about anxiety and HIV medication adherence. During this session, Patient 2 discussed reasons for wanting to reduce his anxiety and depressive symptoms, including being able to enjoy time with his family. He reported that when his wife passed away, he emotionally “shut down,” resulting in avoidance behavior (e.g., not

ACCEPTED MANUSCRIPT leaving the house, not talking with his children) and that some of this avoidance behavior still impacts his daily life. Motivational interviewing was used to help the patient commit to engaging

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in therapy as a means of reducing his distress and improving his anxiety and depression

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symptoms.

In Session 2, cognitive restructuring strategies were discussed in order to deal with

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negative thoughts and feelings in a healthy way. Cognitive restructuring included challenging

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thoughts such as “I cannot remember to take my medication.” After this session, Patient 2 bought a pillbox to help with consistent medication adherence. Additional exercises included

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conceptualization of his children’s parenting strategies (e.g., “I may not agree with what they’re doing, but the kids are safe and doing well in school. Maybe I should trust their parenting a little

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more”). He created a new mental script when worries came to him: “This is your day now,” which he reported using during the following week as a homework exercise that helped him

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overcome his desire to avoid in the face of anxiety. During Session 3, IE exposure exercises were completed. Hyperventilation was used as a safe method of increasing physiological responses similar to anxiety Patient 2 felt in regard to anxiety and depressive symptoms. He was asked to rate the distress experienced by these exercises using a 100-point SUDS. Three exposures were conducted in session, with his SUDS reaching a high point of 70, and, by the third exposure exercises, reducing to 0 within 2 minutes of the exercise. The patient was assigned daily practice of IE exposures for homework. Sessions 4–6 included in vivo exposure exercises. During Session 4, Patient 2 conducted an exposure of administering an insulin shot in public. He reported feeling more comfortable than he imagined doing this, and generalized this new information to include his ability to take his HIV medications in public. Homework for the following week included taking medications in

ACCEPTED MANUSCRIPT public at least once. Session 5 focused on continuing to increase health behaviors, including taking all of his medications, and restructuring negative thoughts about his health and the safety

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of others. Homework included taking medications every day between Sessions 5 and 6. During

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Session 6, Patient 2 indicated that he had sought additional services for his subclinical marijuana use, and in vivo exercises in session included talking to others about his physical health problems

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and treatment plans in the clinic.

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During the course of treatment, Patient 2 made marked improvements in anxiety, depression, and HIV medication adherence and also made gains in mood and affect, although

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these were not the primary goals of this program. His trait anxiety (STAI-T = 56 at baseline, 54 at week 3, 38 at termination) fell below clinical average (52.3; Bieling et al., 1998; see Figure 1).

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Regarding his fear of anxiety-relevant sensations, his ASI-3 score was high at week 3 (53), but fell below the clinical average (29.5; Taylor et al., 2007) at posttreatment (27). Patient 2’s ratings

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of psychological quality of life were steady from baseline (WHOQOL-BREF-Psychological = 25) to week 3 (25) but improved at termination (44). Patient 2’s past 2-week HIV medication adherence also improved significantly during the course of treatment, with the patient reporting adhering to only 79% of medications at baseline, 100% of medications at week 3 follow-up, and 93% of past 2-week medications at termination. Notably, although depression was not explicitly targeted in any session, his IDAS-Depression score decreased from 76 at intake to 51 by termination.

Follow-Up During the course of the treatment, Patient 2 made marked improvements in anxiety and depressive symptoms as well as HIV medication adherence. He was reassessed at 1-month

ACCEPTED MANUSCRIPT posttreatment termination; generally, his treatment gains were maintained. Specifically, trait anxiety stayed below the clinical average (STAI-T = 45); however, ASI-3 scores regressed to

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midtreatment levels (ASI-3 = 54) and psychological quality of life reduced from termination

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(WHOQOL-BREF-Psychological = 44) to follow-up (38). Patient 2’s medication adherence was above pretreatment levels (86% vs. 79%) at follow-up and depressive symptoms also continued

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to improve posttreatment (IDAS-Depression = 41). See Figure 1 for a graphical representation of

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Patient 2’s follow-up data. Regarding psychiatric diagnoses, the patient was readministered the

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MINI at the 1-month follow-up appointment, and did not meet criteria for GAD or MDD.

Case Study 3

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Case Introduction

Patient 3 was a 41-year-old heterosexual African American female presenting with a

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desire to reduce her anxiety and depressive symptoms. She self-reported poor HIV medication adherence, having missed most of her medications for over 1 month prior to her baseline assessment.

History of Presenting Complaints Patient 3 reported increased stress in the workplace, experiencing increased HIV-related stigma among coworkers and feeling socially anxious and depressed. She worked at a community outreach center for HIV and reported that her HIV status was known in the workplace. She described a pervasive feeling of having to “explain herself” to others and feeling like she is “case managed” by coworkers. She reported feeling like an “other” and looked down upon by her peers due to her status, stating that people often jump to conclusions and assume she

ACCEPTED MANUSCRIPT had been sexually reckless and/or promiscuous because of prejudice about Black women with HIV. However, she reported that she had been sexually active with only one man, who

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transmitted the disease to her 15 years ago after dating for several years. She reported a constant

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need to “defend herself” from this negative assumption and to prove to others that she did nothing wrong. Patient 3 reported medication interference due to physical sensations of anxiety,

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such as nausea and vomiting, which make her not want to take her medication.

Assessment

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As per the MINI diagnostic interview, Patient 3 met criteria for past-month PTSD resulting from a past sexual assault many years prior and reported fearing her safety as a result of

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the trauma. She reported avoidance of reminders, loss of interest in hobbies, feelings of detachment from others, and numbing feelings, as well as sleep difficulties, irritability, difficulty

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concentrating, feeling on guard, and exaggerated startle response. Patient 3 did not meet criteria for a current major depressive episode. However, she did report feeling depressed most of the time over the past 2 years and met criteria for dysthymia but no current suicidal ideation, intent, or plan. Patient 3 met criteria for social anxiety disorder due to fear and avoidance of multiple social situations, both at work and socially. She reported avoiding situations as well as suffering through work situations and dreading them. Questionnaire-based assessments corresponded with Patient 3’s diagnoses. At baseline assessment, she scored in the clinical range for trait anxiety (STAI-T = 57) and indexed high negative affect (PANAS-NA = 46) and relatively low quality of life (WHOQOL-BREFPsychological = 25). Patient 3’s anxiety sensitivity score was elevated (ASI-3 = 38), as were her

ACCEPTED MANUSCRIPT symptoms of depression (IDAS-Depression = 70). She also reported missing 100% of her HIV

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medications in the past 2 weeks.

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Case Conceptualization

HAMRT was recommended to treat Patient 3’s social anxiety, dysthymia, and

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posttraumatic stress. She reported that experiences of stress adversely impact her medication

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adherence. By treating her emotional symptoms, it was expected that medication adherence would improve. She reported that when she is not stressed, she is “on track” with medications

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but that holidays and other stressors make it difficult to adhere to medications.

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Course of Treatment and Assessment Progress The skills presented in each of the six sessions were presented in the same order as for

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Patient 1. The first session focused on psychoeducation about anxiety and HIV medication adherence. During this session, the patient discussed reasons for wanting to reduce her anxiety and depressive symptoms, including being able to go to work without feeling “dread,” as well as being able to raise her daughter and interact with her family without the intrusion of anxiety. In Session 2, cognitive restructuring strategies were discussed to help with thinking more flexibly. Patient 3 spoke at length about an upcoming holiday party at work that she was dreading—the party was identified as a treatment goal and potential target for future exposures. Homework was assigned including monitoring the physiological, cognitive, and behavioral components of anxiety. The plan for Session 3 was modified slightly due to outside circumstances. Patient 3 engaged in an impromptu exposure, taking the opportunity to deliver a 2-hour impromptu speech

ACCEPTED MANUSCRIPT for an AIDS service organization. She stated that she was motivated by the first two sessions and pushed herself to do this exposure—further, she stated that she noticed anxiety developing in her

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daughter and wanted to make a change in her life as an example to her daughter. Given that

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formal exposures had not been introduced/practiced, the session focused on recapping of the exposure (e.g., post hoc tracking anxiety before, during, and after the exposure), praise for

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approaching rather than avoiding, and cognitive restructuring of remaining automatic thoughts.

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Planned IE exposures for Session 3 were not conducted in lieu of focusing on presenting issues of the patient regarding exposures. This evidences how this therapy, although manualized, can be

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flexibly applied in practice and can adapt to the needs of the patient as they arise. During Session 4, continued cognitive restructuring was conducted. Patient 3 described

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engaging in an exposure of interacting with coworkers and the session focused on challenging

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remaining thoughts such as “My judgment is questioned because I am positive.” She noticed that

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she more readily believes her negative thoughts when she is annoyed and that she ignores coworkers when annoyed. She concluded that ignoring coworkers could be contributing to their negative interactions with her. Relatedly, she noticed that when she engages them, things go more smoothly socially, and they interact more positively with her. She also challenged thoughts such as “They don’t want me here,” and gathered evidence for and against the thought. Patient 3 also practiced perspective taking by comparing how she responds to her negative automatic thoughts to how she would respond if a loved one had the same negative automatic thought. The patient noted that she is harder on herself and tends to be kind to others but not herself. Session 5 continued cognitive restructuring and review of exposures conducted out of session. Patient 3 engaged in an exposure before the session of attending a party with coworkers. Initially, a party with coworkers was rated as not an option for exposures. Additionally, the

ACCEPTED MANUSCRIPT patient noticed that others were listening to her more after engaging with them socially and that her anxiety had reduced and she was able to start eating breakfast again, which she usually did

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not do as a result of prework anxiety and nausea. In Session 6, Patient 3 conducted an exposure in the form of a worry script. She created a

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one-page script and read it out loud because her automatic thought was that it would be “more

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real” by reading it out loud. The script focused on themes of job security, in which she stated that

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she was worried about her job and that hers is “the easiest to get rid of” as she was “at the bottom of the pay scale.” She worried that she did not have enough education to get another job and

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feared that any other job she got would not be fulfilling. She stated that her job made her feel like she “had value and worth” and without it she would “have no value and no worth.” Her SUDS

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reached 80 while writing the worry script and reduced to 50 after reading aloud, then a 40 after reading a second time, and ending at a 30 after reading a final time. The patient noted that it was

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difficult hearing her thoughts and having them “become real.” She noted physical sensations being activated during the repeated readings.

Follow-Up

During the course of the treatment, Patient 3 made marked improvements in anxiety and depressive symptoms as well as HIV medication adherence. The patient continued these gains at the 1-month follow-up. See Figure 1 for a graphical representation of Patient 3’s follow-up data. During the course of the treatment, Patient 3 made marked improvements in anxiety and depressive symptoms, anxiety sensitivity, positive affect, negative affect, and HIV medication adherence, and generally continued these gains at the 1-month follow-up. Regarding anxiety, STAI-T scores fell from baseline to posttreatment, and stayed relatively stable at follow-up (47,

ACCEPTED MANUSCRIPT 45, and 42, respectively). Regarding anxiety sensitivity, Patient 3 reduced at week 3 (25) and week 6 (9). She rebounded slightly at 1-month follow-up (23) but did not return to her baseline

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level (38) and remained below the clinical average for ASI-3 (Taylor et al., 2007). Her

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medication adherence improved from 0% at baseline to 50% at week 3. Although it reduced to 36% at week 6, she reported 100% adherence at 1-month follow-up. Depressive symptoms

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decreased over treatment, and gains were maintained at follow-up (45, 41, 39) falling below the

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community average (M = 45.0; Watson et al., 2007). Psychological quality of life improved throughout treatment from baseline (WHOQOL-BREF-Psychological = 25) to week 3 (31), week

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6 (44), and follow-up (56). Regarding psychiatric diagnoses, Patient 3 was readministered the MINI at the 1-month follow-up appointment. She reported no reexperiencing of her trauma in the

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past month and no longer met criteria for PTSD or for social phobia. She did still meet criteria

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for dysthymia; however, she stated that she had not felt sad in the past month.

Discussion

In the present study, we evaluated a novel six-session CBT-based transdiagnostic anxiety reduction therapy designed to help improve cART adherence among PLHIV. The treatment yielded encouraging results in terms of all targeted dependent measures (i.e., increased cART adherence and decreased anxiety and anxiety sensitivity) and additionally indicated positive results in terms of related (though not specifically targeted) outcomes (i.e., reduced depression and negative affect, improved quality of life). These results were generally maintained at 1month posttreatment. Specifically, in regard to cART adherence, all participants improved adherence between pretreatment and end-of-treatment sessions, and all three maintained or improved adherence rates at posttreatment. This study is the first of its kind to examine the

ACCEPTED MANUSCRIPT effects of an anxiety-reduction program on cART adherence among PLHIV, and it provides novel evidence that anxiety reduction may be a viable tool to assist with adherence. This is

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critically important given that PLHIV who are adherent to medications experience anxiety

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symptoms and disorders more commonly than the general population (Bing et al., 2001; Brandt et al., 2017).

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Additionally, as hypothesized, the novel CBT-based transdiagnostic anxiety-reduction

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program notably reduced trait anxiety levels among study participants. All participants reported anxiety symptoms above the clinical average at pretreatment assessment, and each participant

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experienced reductions in trait anxiety to below clinical average by posttreatment, with these gains maintaining or improving at 1-month posttreatment. This finding supports earlier work

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indicating that transdiagnostic anxiety treatment (i.e., treatment that targets common underlying factors across anxiety disorders instead of disorder-specific symptom clusters; Norton & Paulus,

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2016) is effective, and extends this work among PLHIV. Also consistent with the design and focus of treatment, as well as the transdiagnostic focus, results indicated notable reductions in anxiety sensitivity. However, unlike other outcomes, these gains were not maintained for all persons. For two of three individuals, anxiety sensitivity reduction was not maintained between end of treatment and follow-up. For Patient 2, anxiety sensitivity returned to baseline by the 1-month follow-up time point. Given that anxiety sensitivity reduction was a treatment focus for only one session (Session 3), it may be that a higher dose of interoceptive exposure is needed to produce and maintain these reductions. Indeed, PLHIV may experience consistent symptoms of pain and/or anxiety, and multiple therapy sessions may be needed for patients to internalize and maintain a reduction in anxiety

ACCEPTED MANUSCRIPT sensitivity. Future work should extend the current treatment model, examining the effects of utilizing anxiety sensitivity reduction techniques over the course of therapy.

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For secondary dependent variables, including negative affect, depression, and quality of

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life, results followed the same general pattern as primary results. Specifically, rates of depression and negative affect fell consistently from pretreatment to posttreatment for each participant, and

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these results were maintained at the 1-month posttreatment session. Similarly, rates of

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psychological quality of life improved during treatment for participants, and these results were also maintained posttreatment. These results are in line with transdiagnostic theory that targeting

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underlying mechanisms for mental health will impact a wider range of outcomes than disorderspecific symptoms (e.g., Barlow et al., 2010) and extend this work to PLHIV. This extension is

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particularly important given the high rates of mulitmorbidity present among this population (e.g., Bing et al., 2001). Improvements in quality of life are important, providing evidence that the

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treatment does more than reduce negative aspects of patients’ lives (i.e., anxiety), but also that it results in some positive impact.

The current study has a number of limitations. First, the sample size is small, limiting generalizability of results. Second, although we attempted to discuss clients of different demographic groups here, future work should utilize larger samples to mitigate this concern. Third, we did not formally assess homework compliance, adherence, or acceptability of treatment via standardized instruments. Past work has indicated that homework compliance can improve treatment outcomes (Kazantzis et al., 2016). Future research on this program could benefit by adding formalized documentation of homework compliance and its effect on treatment outcomes.

ACCEPTED MANUSCRIPT Overall, the present study provides novel empirical data on HAMRT for PLHIV who experience concurrent anxiety and cART underadherence. The results suggest potential clinical

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utility for a CBT-based transdiagnostic intervention in regard to reducing psychological distress

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(e.g., anxiety, depression, anxiety sensitivity) and improving cART adherence and psychological quality of life among PLHIV. There are many potential next steps for this program. First,

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improvements in anxiety sensitivity were the least stable among all outcome variables. It may be

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that a greater focus on anxiety sensitivity reduction during treatment may produce more consistent gains. Relatedly, a shorter (e.g., two to four sessions) program focused exclusively on

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anxiety sensitivity reduction may be a viable alternative for PLHIV seeking treatment who do not have the time or resources to commit to six sessions of therapy. Additionally, integration of

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this program into existing health care services (e.g., administration during doctor’s appointments, blood work appointments, prescription refill appointments) may help to make this program

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maximally accessible for PLHIV who already have a significant medical appointment burden. Finally, this program may be generalizable to other chronically ill populations (e.g., cancer, diabetes) that require daily self-care. Many chronically ill groups have high rates of anxiety (e.g., Mosher, Winger, Given, Helft, & O’Neil, 2016) and associated problems with self-care (Janzen Claude, Hadjistavropoulos, & Friesen, 2014) and the HAMRT intervention may be helpful at decreasing anxiety and increasing self-care with minimal changes to the treatment itself. Additionally, this program may show generalizability to other groups suffering from physical illnesses.

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Figure 1. Trajectories of outcomes over the course of treatment and follow-up.

ACCEPTED MANUSCRIPT Highlights 

A six-session CBT-based transdiagnostic anxiety treatment was administered to three

Persons receiving treatment showed decreases in anxiety symptoms, anxiety sensitivity,

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persons living with HIV.

Persons receiving treatment showed increases in HIV medication adherence and quality

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of life.

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depression symptoms, and negative affect.