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

Not Applicable

Completed

• Conditions: Depressive Symptoms

• 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

Study Timeline

• Study Start: 2017-10-10
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

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

Primary Outcome Measures

Name	Time	Method
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months	Measured 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 Schizophrenia	Measured 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 notes	Measured 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

Name	Time	Method
Emotions	Measured at baseline, weeks 2,4 and 6.	Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).
Positive and negative thoughts	Measured at baseline, weeks 2,4 and 6.	Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).
Negative life events	Measured at baseline	Evaluate difference (if any) in self-reported negative life events
Assessments using writing samples	Measured 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-9	Measured 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 domains	Measured 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-7	Measured at baseline, 6 weeks, 3 months and 6 months	Evaluate difference (if any) in self-reported depression and anxiety symptoms
Health care utilization	Measured 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 thoughts	Measured 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 use	Measured 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 level	Measured at baseline, weeks 2,4 and 6.	Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).
Negative attributional style	Measured 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