Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.

Official Title
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Depression Prevention Programs: A Pilot Trial

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Group-based therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current student at the University of Oregon subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater Exclusion Criteria: current diagnosis of major depression acute suicidal ideation requiring immediate mental health treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Change Ahead<br>Each of the 6 weekly 1-hour sessions begins with a voluntary commitment to actively participate and to try something new in the upcoming week; includes a section devoted to selecting and publicly committing to one change focused on reducing negative/increasing positive cognitions and one change focused on increasing pleasant activities; and ends with home practice assignments. Additional exercises designed to increase dissonance induction include (a) group discussions for changing conditions, (b) roleplays to generate quick comebacks to written negative thoughts provided by other group members, (c) in-session writing exercises on the benefits of doing fun activities, (d) discussion of methods for creating internal and external accountability for positive change, (e) home practice assignment of engaging in actions to help someone else' mood, (f) writing a letter to my future self about positive intentions, and (g) providing positive feedback to other group members at the last session. | Behavioral: Group-based therapy<br>* College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.<br>|
| Active Comparator: Blues Program<br>The 6 weekly 1-hour sessions begin with a review of concepts and (after Session 1) review of past home practice assignments; all sessions conclude with home practice assignments. Each session has a portion devoted to thought identification/recording and cognitive restructuring and a portion devoted to increased involvement in pleasant activities. We use motivational enhancement exercises to maximize willingness to use the new skills, behavioral techniques to reinforce use of the new skills, and group activities to foster feelings of group cohesion. | Behavioral: Group-based therapy<br>* College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.<br>|
| Placebo Comparator: Brochure control<br>NIMH brochure that describes major depression and recommends treatment for depressed youth (Let's Talk About Depression NIH Pub. 01-4162), as well as information about local treatment options. | Behavioral: Group-based therapy<br>* College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months | Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks. | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Difference in attendance in Change Ahead vs Blues Program groups using group leader notes | Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes. | Measured at each group therapy session (6 weeks in total). | 
| Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia | Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months. | Measured at baseline, 6 weeks, 3 months and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity level | Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs). | Measured at baseline, weeks 2,4 and 6. | 
| Emotions | Evaluate the participants emotions using Ecological Momentary Assessments (EMAs). | Measured at baseline, weeks 2,4 and 6. | 
| Positive and negative thoughts | Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs). | Measured at baseline, weeks 2,4 and 6. | 
| Assessments using writing samples | Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future. | Measured at baseline and 6 weeks | 
| Depression and anxiety symptoms using the PHQ-9 | Evaluate difference (if any) in self-reported depression and anxiety symptoms | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Depression and anxiety symptoms using the GAD-7 | Evaluate difference (if any) in self-reported depression and anxiety symptoms | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Social adjustment in school, work, peer, spare time, and family domains | Evaluate difference (if any) in self-reported social adjustment using 17 items adapted from Social Adjustment Scale-Self Report for Youth (Weissman, Orvaschel, & Padian, 1980) | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Negative life events | Evaluate difference (if any) in self-reported negative life events | Measured at baseline | 
| Health care utilization | Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems. | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Negative automatic thoughts | Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980) | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Negative attributional style | Evaluate difference (if any) in self-reported negative attributional style | Measured at baseline, 6 weeks, 3 months and 6 months | 
| Substance use | Evaluate difference (in any) in self-reported substance use using 10 items from Stice, Barrera and Chassin (1998). Participants report the frequency of intake of beer/wine/wine coolers and hard liquor, frequency of heavy drinking (5 or more drinks in a row), frequency of times drunk, and frequency of marijuana, stimulants, downers, inhalants, and hallucinogen use. | Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months |