MedPath

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

Not Applicable
Completed
Conditions
Depressive Symptoms
Interventions
Behavioral: Group-based therapy
Registration Number
NCT04111887
Lead Sponsor
Oregon Research Institute
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
91
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Blues ProgramGroup-based therapyThe 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.
Change AheadGroup-based therapyEach 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.
Brochure controlGroup-based therapyNIMH 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.
Primary Outcome Measures
NameTimeMethod
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 monthsMeasured at baseline, 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.

Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and SchizophreniaMeasured at baseline, 6 weeks, 3 months and 6 months.

Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.

Difference in attendance in Change Ahead vs Blues Program groups using group leader notesMeasured at each group therapy session (6 weeks in total).

Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.

Secondary Outcome Measures
NameTimeMethod
EmotionsMeasured at baseline, weeks 2,4 and 6.

Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).

Positive and negative thoughtsMeasured at baseline, weeks 2,4 and 6.

Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).

Negative life eventsMeasured at baseline

Evaluate difference (if any) in self-reported negative life events

Assessments using writing samplesMeasured at baseline and 6 weeks

Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.

Depression and anxiety symptoms using the PHQ-9Measured at baseline, 6 weeks, 3 months and 6 months

Evaluate difference (if any) in self-reported depression and anxiety symptoms

Social adjustment in school, work, peer, spare time, and family domainsMeasured at baseline, 6 weeks, 3 months and 6 months

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)

Depression and anxiety symptoms using the GAD-7Measured at baseline, 6 weeks, 3 months and 6 months

Evaluate difference (if any) in self-reported depression and anxiety symptoms

Health care utilizationMeasured at baseline, 6 weeks, 3 months and 6 months

Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems.

Negative automatic thoughtsMeasured at baseline, 6 weeks, 3 months and 6 months

Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon \& Kendall, 1980)

Substance useMeasured at baseline (in intake screener), 6 weeks, 3 months and 6 months

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.

Activity levelMeasured at baseline, weeks 2,4 and 6.

Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).

Negative attributional styleMeasured at baseline, 6 weeks, 3 months and 6 months

Evaluate difference (if any) in self-reported negative attributional style

Trial Locations

Locations (1)

Oregon Research Institute

🇺🇸

Eugene, Oregon, United States

© Copyright 2025. All Rights Reserved by MedPath