A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol

Journal Pre-proof A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol

Tera L. Fazzino, Carl W. Lejuez, Richard Yi PII:

S1551-7144(20)30028-8

DOI:

https://doi.org/10.1016/j.cct.2020.105950

Reference:

CONCLI 105950

To appear in:

Contemporary Clinical Trials

Received date:

21 October 2019

Revised date:

13 January 2020

Accepted date:

21 January 2020

Please cite this article as: T.L. Fazzino, C.W. Lejuez and R. Yi, A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol, Contemporary Clinical Trials(2020), https://doi.org/10.1016/j.cct.2020.105950

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© 2020 Published by Elsevier.

Journal Pre-proof A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol

Tera L. Fazzino, PhDa,b, Carl W. Lejuez, PhDa,b, Richard Yi, PhDa,b

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Department of Psychology, University of Kansas b

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Cofrin Logan Center for Addiction Research and Treatment, University of Kansas a

Contact Information:

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Tera Fazzino, PhD

4th Floor

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Lawrence, KS 66046

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1415 Jayhawk Blvd

Clinical Trials Registration Number: NCT04038190

Journal Pre-proof Abstract Introduction: The transition from high school to college is a developmentally sensitive period that is high-risk for the escalation of alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. College alcohol interventions target drinking directly at a time when students may be uninterested in changing their drinking. Approaches that indirectly target drinking may be particularly effective. Behavioral activation

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(BA) is an intervention that indirectly addresses mental health conditions by guiding individuals to engage in reinforcing activities that align with their values (Lejuez et al, 2001). A pilot study of

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a BA intervention administered in a semester-long freshman orientation course reported a

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significant decrease in drinking-related problems compared to students in standard orientation

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course (Reynolds et al, 2011).

Methods: The cluster-randomized trial will test the efficacy of BA administered in a semester-

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long (16 week) freshman orientation course, compared to a standard orientation course in 540

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freshmen spread over 36 course sections (18 sections each). A 5-month post-treatment assessment will measure durability of effects.

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Discussion: The study will test a promising BA intervention that addresses factors limiting

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participation in other programs by targeting alcohol use indirectly and by integrating an intervention into college curriculum. This study represents a first step toward developing an intervention course that could be widely disseminated to address the persistent college drinking problem and its consequences.

Keywords: behavioral activation; behavioral intervention; college; freshmen; drinking; alcohol use

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Introduction The transition from high school to college is a developmentally sensitive period that is high-risk for escalations in alcohol use. This period is characterized by continued neurodevelopment in brain regions responsible for self-regulatory behavior, combined with expanding access to alcohol on and off campus 1,2. Over the past decade, college drinking rates have declined modestly3,4. At the same time, subgroups of students have emerged who engage in extreme binge drinking (10+ drinks per occasion) and the gender gap in risky drinking rates is

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closing, suggesting that college drinking remains a serious issue that requires further attention4– 6

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. Evidence points to the college environment itself as being a risk factor for heavy drinking.

Over the past 15 years, college students have consistently engaged in risky drinking at rates

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about 10% higher rates than their non-college attending peers in any given year 4. Thus, new

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approaches are needed to address the persistent college drinking problem and its many

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consequences.

Many universities in the United States (US) address alcohol prevention at the individual

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level by making brief web-based intervention (WBI) programs available to students 7. While WBIs are scalable and cost effective, they lack individualization beyond correction of normative

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assumptions about drinking. As such, WBIs result in small effects that are time-limited, and their

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underwhelming effects have prompted researchers to questions their utility8. Interventions that yield greater efficacy than WBIs require more intensive treatment contact and duration9. However, only ~1% of students seek formal treatment for a substance use during college10. The low engagement rate may be due to the fact that interventions target drinking directly at a time when students either may not realize they have a problem or are uninterested in changing their drinking. Instead of directly focusing on alcohol use, there may be value in approaches that can indirectly reduce drinking. Behavioral activation (BA) is a brief treatment approach based in reinforcement theory that aims to address mental health problems indirectly by guiding individuals to identify values in

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their lives, and encouraging individuals to engage in reinforcing activities that align with their values 11. While initially used to treat depression, BA has been efficaciously applied to substance use because it targets the same reinforcement process implicated in substance use12. Reinforcement theory suggests that substance use occurs in circumstances in which there is an imbalance between reinforcement obtained from substance use and alternative activities 13. BA thus targets increasing engagement in reinforcing activities, addressing a core process

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implicated in heavy drinking, without directly mentioning alcohol use. In a pilot study, the efficacy of BA administered in semester-long college orientation courses was compared to

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standard orientation courses. Notably, while the approach never raised the issue of drinking, it

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led to a significant decrease in drinking-related problems during the first semester of college14.

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A strength of BA is that it addresses a core reinforcement process that is central to many health behavior problems. In addition to substance use, other problems common to college

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freshmen, such as stress, depression, and unhealthy eating (American College Health

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Association, 2017) may also result from an imbalance in environmental reinforcement. For example, some freshmen may experience the transition to college as particularly stressful.

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Freshmen enter a new environment on campus, have increased responsibilities for coursework

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and daily living and form new social relationships. If these situations are experienced as negative and are balanced by few environmental reinforcements, students may seek reinforcement from unhealthy sources, such as drinking or binge eating highly palatable foods. Some students may respond to stress by withdrawing from their environment (and potential reinforcing opportunities within it), which may lead to depression over time. The current study (detailed below) will be a fully-powered cluster-randomized clinical trial testing the efficacy of BA vs control condition on alcohol outcomes, as well as clinical health problems that are also influenced by the reinforcement system.

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Methods Study Purpose and Hypotheses The present study will be a cluster-randomized trial testing the efficacy of BA administered in a semester-long (16 week) freshmen orientation course, compared to a standard orientation course (SO) for addressing alcohol use and related clinical outcomes. Thirty-six 36 course sections (18 course sections for BA and 18 for SO) will be conducted in

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total, with N=540 participants. Mediation analyses will test mechanisms of action and moderation analyses will test the efficacy of the intervention based on key variables of interest.

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We hypothesize that 1a) the BA intervention will lead to significant reductions in drinking

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and drinking problems during the first semester of college, and reductions will be significantly

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greater than in the SO control condition. We also hypothesize that 1b) lower drinking outcomes will be sustained in the BA condition at 5 months-post treatment compared to SO. Mechanisms

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leading to change in alcohol use are hypothesized to be 2a) increased environmental

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reinforcement and 2b) decreased delay discounting. The BA intervention may help mitigate the development of the following clinical outcomes: stress, depression, and binge eating, because

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these problems are influenced by the reinforcement system that BA targets (exploratory aim 3).

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The BA intervention may be particularly efficacious for students who drink to cope with stress. Moderators of treatment efficacy: coping-motivated drinking, sex, and race/ethnicity will be explored (aim 4).

Randomization Randomization will occur at the course level. Randomization will employ blocking across morning and afternoon times and will occur within years.

Participant Recruitment and Enrollment In collaboration with the University Director of Orientations, 36 sections of the existing,

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semester-long UNIV 101 freshman orientation curriculum will be modified and taught by research study staff. Each section will be randomly assigned to a condition, with 18 sections assigned to BA and 18 assigned to SO. Students will enroll into the offered UNIV 101 course sections independent of the research study by registering with the University’s standard online course registration system. The 36 sections will be paired such that BA and SO classes will be offered at the same time of day and will be matched for treatment contact time.

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Students enrolled into the BA and SO course sections will be offered the opportunity to participate in the research assessment portion of the study during the first week of class.

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Students aged 18+ will provide written informed consent, and students under age 18 will be

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required to sign an assent form and to obtain written parental permission to participate.

Assessment Schedule

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Participants will be assessed at three times during treatment (weeks 1,7, and 15), all of

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which will occur during the first semester. At the end of the academic year (April of spring semester), students will complete a final 5-month follow up assessment to test durability of

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treatment effects. The study will also test longer-term (17-month) efficacy in a random

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subsample of 20% of participants in Years 2-4, which will occur at the end of participant’s sophomore year. While an extended follow up assessment of all N=540 participants is beyond the scope of the project, the longer follow-up on a random subsample of participants will provide an initial indication of longer-term efficacy. The 17-month follow up will yield approximately n=100 participants (n=50 BA condition and n=50 standard orientation condition). Assessments during the intervention (weeks 1, 7, and 15) will be conducted in the classrooms in which the courses will be run, to facilitate participation. At follow up(s), participants will be contact via text and email and scheduled to attend the follow up assessment(s) at a study lab, which is located centrally on campus. Participants will be provided an escalating incentive schedule to maximize attendance at follow up(s), as described below.

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Incentives Participants will receive extra credit in their UNIV 101 course for participating in Assessments 1-3, and will be compensated $50 for completing Assessment 4, which will occur after the courses have finished. To ensure participation in the research will not be coerced, students will be offered alternative extra credit assignments that will require approximately the

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same amount of time as participating in the study. The subsample of students participating in

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Assessment 5 (17-month follow up) will receive $75 for completing the final assessment.

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Research Staff

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Research assistants who will collect study data will not be affiliated with the courses and will be blinded to study condition. Likewise, clinical staff who lead the course sections will not be

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involved in research assessment administration and will be blind to participant responses.

Course and Intervention Content

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SO course. The standard orientation course, UNIV 101, is designed to facilitate student

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adjustment to academics and campus life. UNIV 101 courses meet twice weekly for 50 minutes each. The course content is structured around four main themes: 1) academic and personal wellness; 2) experiential learning; 3) social justice; and 4) skill building. Within these themes, lessons address a variety of subjects, from introductions to academic resources on campus (e.g., the university writing center, library, advising), tours of campus venues, presentations from speakers, and academic success topics such as time management. Students are required to develop an individualized academic plan during the course. Work to be completed outside of class is required and includes development of the academic plan, writing and reflection

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assignments, projects that facilitate goal setting, and academic projects such as an annotated bibliography assignment to facilitate academic information literacy.

BA course. The BA course will include all major instructional content of the standard orientation course (main themes and assignments), as well as the BA content. The BA content will replace the supplemental topics and sessions from the standard orientation course, thus

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retaining key SO content while incorporating BA content. The goal of BA for addressing alcohol use is to identify, develop and reinforce healthy behaviors that can serve as alternatives to

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alcohol use. In addition, BA supports students in identifying areas of importance and concern

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(e.g., stress after arriving on campus), and guides them to engage in reinforcing behavior that

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best addresses their concerns and aligns with their goals (e.g., engaging in self-care for stress management, in service of a goal to performing well in classes). The basic components of BA

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that will be used to achieve these outcomes are 1) facilitating students’ engagement in self-

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monitoring of daily activities; 2) guiding students to identify values within a variety of life areas; 3) identifying and engaging in reinforcing activities that align with their values; 4) providing

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Table 1.

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support to engage in activities as identified. BA course sessions and content are summarized in

Week Week 1

Table 1. Behavioral Activation in UNIV 101: Course Content Overview BA Content BA Work Outside of Class Introduction of treatment rationale: focus on Daily monitoring of activities, ratings of engaging in reinforcing activities to promote a activity enjoyment rewarding college lifestyle;

Week 2

Introduction to daily monitoring Life areas and values: students will be guided in identifying their values within various life domains

Week 3

Identification of activities that align with values;

Week 4

Planning activities using the daily monitoring form Engaging support to complete planned activities

Daily monitoring of activities, ratings of activity enjoyment and importance Daily monitoring, ratings of activity enjoyment and importance, planning activities using the daily monitoring form Daily monitoring, ratings of activity enjoyment and importance, planning activities using the daily monitoring form

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Weeks 5-14

Periodic BA review sessions

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Daily monitoring, ratings of activity enjoyment and importance, planning activities using the daily monitoring form

Note. BA= behavioral activation

Materials for BA course. College students are technologically-savvy and mobile phone use in this population is extensive; 95% of college students own smartphones 15. Thus, to facilitate

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use and engagement with BA materials (e.g., daily monitoring), all materials will be provided

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through a web-based platform that students will be able to access via any computer-based device (smartphones, computers, tablet devices). However, alternatives to the web-based

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platform will be offered to students who prefer to complete forms using paper.

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Instructor training and supervision. The instructors will undergo extensive training before delivering treatment and will be supervised by the study’s Clinical Supervisor. In addition,

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weekly supervision will be provided. Manuals will be used at all times to ensure standardization of treatment. All course sessions will be audiotaped and participant confidentiality will be

Measures

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protected by storing all recorded data on a HIPAA-secured server.

Assessment will focus on three domains: (1) alcohol use and alcohol-related problems, (2) reinforcement processes (3) clinical health outcomes and moderators. Measures of treatment compliance and fidelity are also described below.

Alcohol Use and Problems Alcohol use and problems in the past month will be assessed using two measures:

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The Alcohol Use Disorder Identification Test (AUDIT)16 is a 10-item questionnaire designed to assess hazardous drinking and related problems. The AUDIT provides a total score, with 8+ indicating hazardous use17,18. The AUDIT has also been examined as two subscales: alcohol consumption (items 1-3 focused on frequency and quantity) and alcohol problems (items 4-10 that assess consequences)19–21. The percent of participants above the clinical cutoff for the total score will be used in analyses, as well as both subscale scores. While

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the AUDIT was originally designed to assess a time interval of the past 12 months, researchers have assessed change in alcohol use and related problems in shorter time intervals of 1, 3, and

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6 months 14,22. The present study will use the past month as the reference point for the AUDIT.

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The computerized Time Line Follow Back (TLFB-C) will be used to assess daily alcohol use in standard drinks during the past month23–25. The TLFB-C has good test-retest reliability

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and evidence of convergent validity with the TLFB administered in-person among college

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student samples 26,27. Heavy drinking occasions will be defined as 4+ drinks for females, or 5+ for males in one episode, in excess of the low risk drinking guidelines from the National Institute

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on Alcohol Use and Alcoholism 28. High-intensity drinking occasions will be defined as double the

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heavy drinking occasion criteria, or 8+ for females and 10+ for males.

Reinforcement Processes

Environmental reinforcement. The Adolescent Reinforcement Survey Schedule - Alcohol Use Version (ARSS-AUV) assesses the frequency of past-month engagement in and enjoyment derived from 45 activities 29. Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol. Frequency and enjoyment items are summed to form respective scores and then multiplied to form subscales for alcohol-related reinforcement and alcohol-free reinforcement. The two subscales are used to calculate the

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outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement.

Delay discounting. A computerized binary choice procedure will assess DD. On each DD trial, two hypothetical money rewards will be presented on the screen. One outcome will be an amount of money available immediately; the other outcome will be a larger amount of money

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($25, $100) available after a specified delay (1 day, 1 week, 1 month, 6 months, 1 year, 5 years). Participants will indicate the preferred alternative with a click and the computerized

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algorithm will adjust the immediate reward over 6 trials to determine an indifference point for

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each amount/delay pairing. Indifference points will be used to calculate a delay discount rate.

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Subjects will be told to indicate preference on the task as if the outcomes were for real money; research has indicated the statistical equivalence of DD tasks for hypothetical and real

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rewards 30.

Clinical Outcomes and Moderators

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Stress and depression. The Depression Anxiety Stress Scale-21 (DASS-21)31 is a 21-

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item measure that has subscales for stress, depression, and anxiety. The DASS-21 measures stress, anxiety, and depression on a dimensional scale and is appropriate for use in a nonclinical, college sample. Studies reported strong internal consistency reliability in clinical and nonclinical samples 31,32, including college students 33.

Binge eating. The Eating Pathology Symptoms Inventory (EPSI) 34 will be used to assess binge eating. The EPSI conceptualizes eating behavior on a dimensional scale and is appropriate for use in samples with and without eating disorders. The binge eating subscale will be used in the study, which includes items on overeating and loss of control eating. The EPSI

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has evidence for excellent discriminant and convergent validity in female and male college students 34,35.

Coping-motivated drinking. The Drinking Motives Questionnaire-Revised (DMQ-R), a measure designed to measure motives for drinking alcohol, will be used to assess copingmotivated drinking36,37. In a variety of young adult and college samples, the DMQ-R has demonstrated high subscale internal consistencies and four factor structure stability38–40. The

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coping scale has been reliably associated with alcohol problems among young adult and college

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samples 38.

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Treatment Compliance and Fidelity

Treatment compliance. Adherence to treatment will be measured by determining

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participants’ completion of daily monitoring forms, and with course attendance (where students

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will receive the intervention content).

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Treatment fidelity. Audio recordings of treatment will be rated by independent raters

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(e.g., raters not otherwise associated with the treatment delivery) to assess instructor adherence to and competence with the treatment protocol, using separate rating checklists and scales developed for the SO and BA protocols. Two senior research assistants will be trained in BA components to perform therapist adherence checks. They will review 20% of all audiotapes and perform competency checks, ratings-based adherence checks, and address any issues with instructors. Their feedback will be implemented in later sessions. Instructors will be required to complete a fidelity checklist for every class session they conduct.

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Statistical Power and Data Analysis Power analysis. A target course section N of 36 (N=18 BA and N=18 SO), with N=432 participants total, will be required to detect medium effect sizes (d=.43) for main outcomes. Each class is expected to contain 18-20 students and power analyses were conducted assuming an 85% consent rate and a 20% attrition at follow up. An 85% consent rate will yield 15 participants per class, or N=540 total. With a 20% attrition rate, we will achieve the N=432

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participants (12 per course section cluster) necessary to detect our outcomes of interest. For

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outcome and BA at a given time point >.20.

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mediation analyses, will have sufficient power to detect a correlation between a drinking

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Data analysis. We will use SAS PROC Mixed with full information Maximum Likelihood estimation to evaluate outcomes using general linear mixed models for continuous outcomes

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and SAS PROC GLIMMIX for binary outcomes. Assignment to treatment condition will occur at

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the class section level (level 3). Student observations (level 1), will be nested in students (level 2), which will be nested within class sections. Fixed effects for intervention condition (BA or SO),

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instructor, and cohort will be included at the class section level. Sex will also be added as a

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fixed effect at level 2. This approach will result in models with appropriate standard errors for the clustered sample.

For aim 1 we will compare differences between BA vs control in likelihood of exceeding the clinical cut-off for risky drinking as a binary outcome, and alcohol consumption (AUDIT consumption questions) and alcohol-related problems (AUDIT problem questions) as continuous outcomes. In addition, we will test differences across conditions in high-intensity drinking. Separate models will be developed for each outcome. Of primary interest are the main effects of treatment condition on both the intercepts and slopes for each of the outcomes. For aim 3 exploratory analyses on stress, depression, and binge eating, outcomes will be modeled separately for each outcome using general linear mixed models.

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Analyses will be conducted to determine whether changes in environmental reinforcement and delay discounting mediate the association between intervention condition and alcohol outcomes. Moderation analyses will be conducted to determine whether intervention efficacy depends on coping-motivated drinking at baseline, sex, or race/ethnicity.

Discussion

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The cluster-randomized trial will be the first large-scale study designed to test the efficacy of BA administered in a freshman orientation seminar for addressing alcohol use and

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related problems during a developmentally sensitive period that is high-risk for escalations in

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alcohol use. The study will address key barriers to intervening on risky drinking among college

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freshmen by targeting alcohol use indirectly, while simultaneously addressing issues and concerns relevant to incoming college freshmen. The implementation of BA into an orientation

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class will provide a semester-long (16 week) duration of treatment, in which the format will be in-

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person, two factors that have been demonstrated to enhance intervention efficacy over standard, web-based brief interventions that are typically used to address college student

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drinking9. Thus, the study may be particularly well tailored to college freshmen and leverages

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the existing infrastructure of university curricula to enhance participation, treatment contact, and treatment duration. In addition, a post-treatment follow-up will be conducted to provide evidence regarding the durability of treatment effects. The study may also provide insights into mechanisms driving BA efficacy. While BA has demonstrated strong efficacy in targeting substance use in a variety of populations, limited information is available regarding mechanisms of action12. Thus, the study will test a primary hypothesized mechanism of action for BA, increased engagement with reinforcing activities that are alternatives to substance use. In addition, the study will test whether a second mechanism of action may be change in delay discounting, with the hypothesis that BA will decrease delay discounting and subsequently reliance on risky drinking for reinforcement. Interventions focused

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on changing delay discounting rates have been conducted primarily with executive functioning training and related cognitive interventions 41, and our test of change in delay discounting from a behavioral activation intervention is new. Given that high delay discounting is associated with poor response to brief interventions typically administered to college freshmen, the therapeutic potential of BA for individuals high in delay discounting is important, and the proposed research may contribute new information about ways in which delay discounting may be modified 41,42.

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The study will also contribute knowledge regarding the efficacy of BA in addressing additional clinical outcomes that are influenced by the reinforcement system. Specifically,

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stress, depression, and binge eating are common among college freshmen43 and may also

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result from an imbalance in environmental reinforcement. BA may help students balance

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reinforcement they experience from their new campus environment and may mitigate the stress of entering college and the development of binge eating and depression. Thus, the study will be

Conclusions and Implications

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the first to test the impact of BA on related clinical outcomes during the first semester of college.

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The study will test a promising intervention approach with BA that may be particularly

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well tailored to the college environment and to freshmen undergraduate students. This study represents a first step in testing the efficacy of an intervention course that could be widely disseminated to address the persistent college drinking problem and its many consequences. Freshmen orientation courses are the norm at U.S. colleges and universities. The vast majority (75-90%) of public and private colleges/universities in the U.S. provide a standard, semesterlong college orientation course in their curriculum specifically designed for freshmen 44,45. Thus, should the intervention demonstrate strong efficacy, the potential to disseminate the intervention and ensure its long-term sustainability is high.

Journal Pre-proof Acknowledgements: The study is funded by the National Institute on Alcohol Abuse and

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Alcoholism, R01 AA027791-01 (PI: Fazzino).

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