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CompletedNCT04111887Updated Sep 16, 2020

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

An interventional study of Group-based therapy in Depressive Symptoms, sponsored by Oregon Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Oregon Research Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2017, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Symptoms

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03

In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 91 is close to the median of 84 across 6,722 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Oregon Research Institute is the lead sponsor of 70 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • current diagnosis of major depression
  • acute suicidal ideation requiring immediate mental health treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralGroup-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  2. 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.

    Time frame: Measured at each group therapy session (6 weeks in total).

  3. 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.

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months.

Secondary outcomes

  1. Activity level

    Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs).

    Time frame: Measured at baseline, weeks 2,4 and 6.

  2. Emotions

    Evaluate the participants emotions using Ecological Momentary Assessments (EMAs).

    Time frame: Measured at baseline, weeks 2,4 and 6.

  3. Positive and negative thoughts

    Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs).

    Time frame: Measured at baseline, weeks 2,4 and 6.

  4. Assessments using writing samples

    Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.

    Time frame: Measured at baseline and 6 weeks

  5. Depression and anxiety symptoms using the PHQ-9

    Evaluate difference (if any) in self-reported depression and anxiety symptoms

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  6. Depression and anxiety symptoms using the GAD-7

    Evaluate difference (if any) in self-reported depression and anxiety symptoms

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  7. 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)

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  8. Negative life events

    Evaluate difference (if any) in self-reported negative life events

    Time frame: Measured at baseline

  9. 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.

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  10. 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)

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  11. Negative attributional style

    Evaluate difference (if any) in self-reported negative attributional style

    Time frame: Measured at baseline, 6 weeks, 3 months and 6 months

  12. 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.

    Time frame: Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months

07

Study locations

1 site
  • Oregon Research Institute
    Eugene, Oregon 97401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04111887
Lead sponsor
Oregon Research Institute
Responsible party
Sponsor
First posted
Oct 1, 2019
Start date
Oct 10, 2017
Primary completion
Dec 13, 2018
Completion
Dec 13, 2018
Last update
Sep 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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