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

Depression Prevention Programs: A Pilot Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04111887
Enrollment
91
Registered
2019-10-01
Start date
2017-10-10
Completion date
2018-12-13
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms

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.

Interventions

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.

Sponsors

Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsEvaluate 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 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.
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.

Secondary

MeasureTime frameDescription
Assessments using writing samplesMeasured at baseline and 6 weeksEvaluate 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 monthsEvaluate difference (if any) in self-reported depression and anxiety symptoms
Depression and anxiety symptoms using the GAD-7Measured at baseline, 6 weeks, 3 months and 6 monthsEvaluate 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 monthsEvaluate difference (if any) in self-reported social adjustment using 17 items adapted from Social Adjustment Scale-Self Report for Youth (Weissman, Orvaschel, & Padian, 1980)
Positive and negative thoughtsMeasured at baseline, weeks 2,4 and 6.Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).
Health care utilizationMeasured at baseline, 6 weeks, 3 months and 6 monthsEvaluate 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 monthsEvaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980)
Negative attributional styleMeasured at baseline, 6 weeks, 3 months and 6 monthsEvaluate difference (if any) in self-reported negative attributional style
Substance useMeasured at baseline (in intake screener), 6 weeks, 3 months and 6 monthsEvaluate 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.
Negative life eventsMeasured at baselineEvaluate difference (if any) in self-reported negative life events
Activity levelMeasured at baseline, weeks 2,4 and 6.Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).
EmotionsMeasured at baseline, weeks 2,4 and 6.Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026