CClinicalTrials.gg
CompletedNCT00073671Updated Jan 31, 2022

Prevention of Depression in At-Risk Adolescents

An interventional study of Cognitive-behavioral prevention program and Usual care in Depression, sponsored by Vanderbilt University. Completed at 4 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
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Study summary

This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

Read the detailed description

Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.

Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

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Conditions studied

  • Depression

Keywords

  • Adolescent
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 316 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

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

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Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A parent has had a depressive disorder during child's life
  • Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)

Exclusion criteria

Exclusion Criteria:

  • adolescent or parent ever diagnosed with bipolar I or schizophrenia;
  • adolescent has a current DSM-IV mood disorder diagnosis
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
316 participants (actual)

Study arms

  • Experimental
    1= Cognitive behavioral prevention of depression program

    Participants receive a group cognitive-behavioral prevention program, which involved 8 weekly sessions and 6 monthly sessions of CBT skills such as cognitive restructuring, problem-solving, assertivenss, and behavioral activation. Participants in this arm also were able to seek the same kinds of nonstudy treatments as described in the usual care arm.

    Behavioral: Cognitive-behavioral prevention program

  • Active comparator
    2 = Usual care

    Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).

    Other: Usual care

Interventions

  • BehavioralCognitive-behavioral prevention program

    Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.

  • OtherUsual care

    Participants receive usual care

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What researchers measure

Primary outcomes

  1. Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)

    a score of 4 or greater is considered an onset

    Time frame: Time to a score of 4 or higher between baseline and 9 months using survival analysis

Secondary outcomes

  1. Number of depression-free days

    Using the depression symptom ratings (DSR) (1-6), each week is given a score of 1 to 6; depression-free days are those with ratings of 1 or 2 on the DSR.

    Time frame: Measured continuously through Month 33

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Study locations

4 sites
  • Harvard University Medical School
    Boston, Massachusetts 02115-5794, United States
  • Kaiser Permanente Center for Health Research
    Portland, Oregon 97227, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213-2593, United States
  • Vanderbilt University
    Nashville, Tennessee 37203-5721, United States
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References and documents

Publications

  • Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24. doi: 10.1001/jama.2009.788. PubMed 19491183 ↗
  • Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295. PubMed 24005242 ↗
  • Brent DA, Brunwasser SM, Hollon SD, Weersing VR, Clarke GN, Dickerson JF, Beardslee WR, Gladstone TR, Porta G, Lynch FL, Iyengar S, Garber J. Effect of a Cognitive-Behavioral Prevention Program on Depression 6 Years After Implementation Among At-Risk Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Nov;72(11):1110-8. doi: 10.1001/jamapsychiatry.2015.1559. PubMed 26421861 ↗
  • Lynch FL, Dickerson JF, Clarke GN, Beardslee WR, Weersing VR, Gladstone TRG, Porta G, Brent DA, Mark TL, DeBar LL, Hollon SD, Garber J. Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up. Psychiatr Serv. 2019 Apr 1;70(4):279-286. doi: 10.1176/appi.ps.201800144. Epub 2019 Jan 3. PubMed 30929618 ↗
  • Weersing VR, Shamseddeen W, Garber J, Hollon SD, Clarke GN, Beardslee WR, Gladstone TR, Lynch FL, Porta G, Iyengar S, Brent DA. Prevention of Depression in At-Risk Adolescents: Predictors and Moderators of Acute Effects. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):219-26. doi: 10.1016/j.jaac.2015.12.015. Epub 2016 Jan 18. PubMed 26903255 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00073671
Lead sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Judith Garber (Professor, Vanderbilt University) — Principal investigator
First posted
Dec 3, 2003
Start date
Mar 2003
Primary completion
Mar 2006
Completion
Jan 2009
Last update
Jan 31, 2022

Study contacts

Judy Garber, PhD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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