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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111887
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Group-based therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Depression Prevention Programs: A Pilot Trial
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months [ Time Frame: Measured at baseline, 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.

  2. Difference in attendance in Change Ahead vs Blues Program groups using group leader notes [ Time Frame: Measured at each group therapy session (6 weeks in total). ]
    Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.

  3. Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months. ]
    Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.


Secondary Outcome Measures :
  1. Assessments using Ecological Momentary Assessments [ Time Frame: Measured at baseline, weeks 2,4 and 6. ]
    Evaluate the participants activity levels, emotions and positive and negative thoughts using Ecological Momentary Assessments (EMAs).

  2. Assessments using writing samples [ Time Frame: Measured at baseline and 6 weeks ]
    Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future.

  3. Depression and anxiety symptoms using the PHQ-9 [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    Evaluate difference (if any) in self-reported depression and anxiety symptoms

  4. Depression and anxiety symptoms using the GAD-7 [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    Evaluate difference (if any) in self-reported depression and anxiety symptoms

  5. Social adjustment in school, work, peer, spare time, and family domains [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    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)

  6. Negative life events [ Time Frame: Measured at baseline ]
    Evaluate difference (if any) in self-reported negative life events

  7. Health care utilization [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems.

  8. Negative automatic thoughts [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980)

  9. Negative attributional style [ Time Frame: Measured at baseline, 6 weeks, 3 months and 6 months ]
    Evaluate difference (if any) in self-reported negative attributional style

  10. Substance use [ Time Frame: Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111887


Locations
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United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
Oregon Research Institute

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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT04111887    
Other Study ID Numbers: Change Ahead
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms