A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

Depression Clinical Trial

Official title:

A Cluster-randomized Trial of a Behavioral Activation Intervention Administered in a College Freshman Orientation Course

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038190
• Other study ID #: STUDY00143954
• Secondary ID: 1R01AA027791-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 5, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: University of Kansas
• Contact: Tera L Fazzino, PhD
• Phone: 7858640062
• Email: tfazzino[@]ku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.

Description:

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. Low rates of engagement with treatment resources may occur because interventions target drinking directly at a time when students may be uninterested in changing their drinking. Moreover, with a targeted focus on alcohol use, current interventions also do not address the concerns of incoming freshmen, such as stress and sleep. Approaches that address the problems students are most concerned about, that also indirectly reduce drinking, may be particularly effective. Behavioral activation (BA) is an intervention that indirectly addresses psychopathy by guiding individuals to identify goals in their lives, and encouraging individuals to engage in reinforcing activities that align with their goals (Lejuez et al, 2001). While initially used to treat depression, BA has been efficaciously applied to substance use because BA acts on the same reinforcement process implicated in problem drinking. BA addresses drinking without specific reference to alcohol use by focusing on engagement in reinforcing activities that align with students' goals. A pilot study provided initial indication that a brief BA intervention administered in a semester-long freshman orientation course resulted in a significant decrease in drinking-related problems, compared to standard orientation (Reynolds et al. 2011). Notably, the approach never raised the issue of drinking unless raised by a student themselves. The purpose of the study is to conduct a fully powered cluster randomized trial testing BA administered in a semester-long (16 week) freshman orientation course, compared to a standard orientation course in 540 freshmen spread over 36 course sections (18 sections each of the BA and standard orientation format). A 5-month post-treatment assessment will measure durability of effects. Mediation analyses will test mechanisms of action and moderation analyses will examine factors related to efficacy. A random sample of 20% of participants will complete a 17 month follow up, which will occur at the end of their sophomore year of college, to examine long term effects. With this proposed R01, the investigators will test a promising intervention with BA that addresses factors limiting participation in other programs by not targeting alcohol directly and by integrating an intervention into college curriculum, with the additional benefit of testing mediators to guide future work. This application represents a first step toward developing an intervention course that could be widely disseminated to address the persistent college drinking problem and its many consequences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol; Use, Problem
• Binge Eating
• Bulimia
• Depression
• Stress

Intervention

Behavioral:
• behavioral activation
Behavioral activation (BA) is an intervention that indirectly addresses psychopathy by guiding individuals to identify goals in their lives, and encouraging individuals to engage in reinforcing activities that align with their goals (Lejuez et al, 2001). While initially used to treat depression, BA has been efficaciously applied to substance use because BA acts on the same reinforcement system common to many disorders (Daughters et al., 2018).

Locations

Country	Name	City	State
United States	University of Kansas	Lawrence	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fazzino TL, Lejuez CW, Yi R. A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol. Contemp Clin Trials. 2020 Mar;90:105950. doi: 10.1016/j.cct.2020.105950. Epub 2020 Jan 23. — View Citation

Fazzino, TL, Kunkel, A, Bellitti, J, Swinburn-Romine, R, Yi, R, & Lejuez, C (2022) Engagement with activity monitoring during a behavioral activation intervention: A randomized test of monitoring format and qualitative evaluation of participant experiences. Behaviour Change; 1-14. DOI: 10.1017/bec.2022.7

Jun D, Fazzino TL. Associations between Alcohol-Free Sources of Reinforcement and the Frequency of Alcohol and Cannabis Co-Use among College Freshmen. Int J Environ Res Public Health. 2023 Feb 7;20(4):2884. doi: 10.3390/ijerph20042884. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	delay discounting	Delay Discounting will be measured using a titrating binary choice task, which uses hypothetical money rewards to assess the degree to which a reward is discounted due to delay. The magnitude of the delayed monetary amount will be $50 and $200 available after a specified delay (1 day, 1 wk, 1 month, 6 months, 1 yr, 5 yrs). Subjects will indicate if they prefer the immediate amount of money or the alternative with a mouse-click and the computerized algorithm will adjust the immediate reward over 6 trials to determine an indifference point for each amount/delay pairing. Indifference points will be used to calculate a delay-discount rate. Higher delay discount rates indicate strong discounting and a preference for immediate rewards.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other	reinforcement from alcohol-related and alcohol-free activities	The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016). 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. Items range from 0-4. Frequency and enjoyment items are summed to form respective scores. From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions. The two subscales are used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement. The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other	coping-motivated drinking	The Drinking Motives Questionnaire-Revised (DMQ-R) designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The measure produces four scales that correspond with the four motives. The present study will use the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater frequency in coping-motivated drinking.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other	grade point average (GPA)	Academic performance will be measured using participate grade point average (GPA).	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other	alcohol violations on campus	Participants alcohol violations at the University of Kansas will be documented at each time point.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Primary	alcohol consumption	Alcohol-Use Disorders Identification Test- Consumption Questions (AUDIT-C), which are the first three items of the AUDIT 10-item measure that asses frequency of drinking, typical quantity, and frequency of heavy drinking occasions (Saunders et al, 1993; Bush et al, 1998; DeMartini et al 2012). Responses are on a likert scale ranging from 0-4. The 3 items are summed for a total score with a possible range of 0-12, with higher scores indicating riskier drinking behavior.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Primary	high-intensity drinking (2+ times in excess of NIAAA low risk drinking guidelines for males and females)	The 30-day Time Line Follow Back-Computerized (TLFB-C) assessment will be used to measure alcohol consumption in the past 30 days (Sobell et al, 1996; Sobell & Sobell, 1992; Sobell & Sobell, 2008). The measure will be used to obtain the frequency at which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females in one occasion.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Primary	alcohol-related problems	Alcohol-Use Disorders Identification Test- Problem Questions (AUDIT-P) are the last 7 items of the full AUDIT that assess increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and drinking that others are concerned about (Saunders et al, 1993; O'Hare & Sherrer, 2005). Responses are on a likert scale ranging from 0-4. The 7 items are summed for a total score with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Primary	exceeding clinical cutoff of 8+ for hazardous/harmful drinking	The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems. The AUDIT has 10 items that assesses frequency of drinking, typical quantity, frequency of heavy drinking, impaired control over drinking, increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and others concerned about (Saunders et al, 1993). Responses are on a likert scale ranging from 0-4. The 10 items are summed for a total score with a possible range of 0-40, with higher scores indicating greater likelihood of hazardous drinking behavior.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Secondary	depression	Depression will be measured using the Depression Anxiety Stress Scale (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The measure provides scales for depression, anxiety, and stress and conceptualizes the difference between normal and clinical populations as a matter of degree. Thus, the DASS-21 is appropriate for use in a non-clinical, college sample. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia with 7 items. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate more depression.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Secondary	binge eating	Binge eating will be measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). 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 proposed study, which includes items on overeating and loss of control eating. The binge eating subscale has 8 items with Likert scale responses from 0=never to 4= very often. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Secondary	stress	Stress will be measured using the Depression Anxiety Stress Scale-21 (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The measure conceptualizes the difference between normal and clinical populations in stress as a matter of degree. Thus, the DASS-21 is appropriate for use in a non-clinical, college sample. b. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient with 7 items. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate more stress.	baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2