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

Primary Purpose

Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group-based therapy
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Change Ahead

Blues Program

Brochure control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Activity level
Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).
Emotions
Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).
Positive and negative thoughts
Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).
Assessments using writing samples
Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.
Depression and anxiety symptoms using the PHQ-9
Evaluate difference (if any) in self-reported depression and anxiety symptoms
Depression and anxiety symptoms using the GAD-7
Evaluate difference (if any) in self-reported depression and anxiety symptoms
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)
Negative life events
Evaluate difference (if any) in self-reported negative life events
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.
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)
Negative attributional style
Evaluate difference (if any) in self-reported negative attributional style
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.

Full Information

First Posted
August 26, 2019
Last Updated
September 14, 2020
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04111887
Brief Title
Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs
Official Title
Depression Prevention Programs: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Change Ahead
Arm Type
Experimental
Arm Description
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.
Arm Title
Blues Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brochure control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months
Description
Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks.
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Difference in attendance in Change Ahead vs Blues Program groups using group leader notes
Description
Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.
Time Frame
Measured at each group therapy session (6 weeks in total).
Title
Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia
Description
Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months.
Secondary Outcome Measure Information:
Title
Activity level
Description
Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).
Time Frame
Measured at baseline, weeks 2,4 and 6.
Title
Emotions
Description
Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).
Time Frame
Measured at baseline, weeks 2,4 and 6.
Title
Positive and negative thoughts
Description
Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).
Time Frame
Measured at baseline, weeks 2,4 and 6.
Title
Assessments using writing samples
Description
Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.
Time Frame
Measured at baseline and 6 weeks
Title
Depression and anxiety symptoms using the PHQ-9
Description
Evaluate difference (if any) in self-reported depression and anxiety symptoms
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Depression and anxiety symptoms using the GAD-7
Description
Evaluate difference (if any) in self-reported depression and anxiety symptoms
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Social adjustment in school, work, peer, spare time, and family domains
Description
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)
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Negative life events
Description
Evaluate difference (if any) in self-reported negative life events
Time Frame
Measured at baseline
Title
Health care utilization
Description
Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems.
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Negative automatic thoughts
Description
Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980)
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Negative attributional style
Description
Evaluate difference (if any) in self-reported negative attributional style
Time Frame
Measured at baseline, 6 weeks, 3 months and 6 months
Title
Substance use
Description
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.
Time Frame
Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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