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Completed

NCT Number: NCT04111887

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

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    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 outcomes

  1. Activity level

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

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

  2. Emotions

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

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

  3. Positive and negative thoughts

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

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

  4. 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.

  5. 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

  6. 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

  7. 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)

  8. Negative life events

    Time frame: Measured at baseline

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

  9. 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.

  10. 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)

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Official study title

Depression Prevention Programs: A Pilot Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2019
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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