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

NCT04111887 | Completed

• 1 other identifier: Change Ahead
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Activity level

  Measured at baseline, weeks 2,4 and 6.

• Emotions

  Measured at baseline, weeks 2,4 and 6.

• Positive and negative thoughts

  Measured at baseline, weeks 2,4 and 6.

• Assessments using writing samples

  Measured at baseline and 6 weeks

• Depression and anxiety symptoms using the PHQ-9

  Measured at baseline, 6 weeks, 3 months and 6 months

Study Arms (3)

Change Ahead

EXPERIMENTAL

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

Blues Program

ACTIVE COMPARATOR

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

Brochure control

PLACEBO COMPARATOR

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

Interventions

Group-based therapy BEHAVIORAL

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.

Blues Program; Brochure control; Change Ahead

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• current student at the University of Oregon
• subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater

You may not qualify if:

• current diagnosis of major depression
• acute suicidal ideation requiring immediate mental health treatment

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: October 1, 2019
• Study Start: October 10, 2017
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)