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

Depressive Symptoms Clinical Trial

Official title:

Depression Prevention Programs: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111887
• Other study ID #: Change Ahead
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: December 13, 2018

Study information

• Verified date: September 2020
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Group-based therapy
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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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).
Primary	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	Activity level	Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).	Measured at baseline, weeks 2,4 and 6.
Secondary	Emotions	Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).	Measured at baseline, weeks 2,4 and 6.
Secondary	Positive and negative thoughts	Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).	Measured at baseline, weeks 2,4 and 6.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Negative life events	Evaluate difference (if any) in self-reported negative life events	Measured at baseline
Secondary	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
Secondary	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
Secondary	Negative attributional style	Evaluate difference (if any) in self-reported negative attributional style	Measured at baseline, 6 weeks, 3 months and 6 months
Secondary	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