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

Depression Prevention Programs: A Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Group-based therapy

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Change Ahead; 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; 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.
ACTIVE_COMPARATOR: Blues Program; 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; 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.
PLACEBO_COMPARATOR: Brochure control; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2017
• Primary Completion (ACTUAL): December 13, 2018
• Study Completion (ACTUAL): December 13, 2018

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Change Ahead

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No