Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

November 7, 2013 updated by: University of Texas Southwestern Medical Center

Continuation Phase CBT for Youth With MDD

This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a chronic and episodic condition that may have devastating effects on social and emotional functioning, particularly in the pediatric population. While approximately 90% of children eventually recover from an episode of depression, up to 40% of those children relapse within 1 to 2 years. Data indicate that cognitive behavioral therapy (CBT) delivered after depressive symptoms subside can significantly reduce depression relapses in adults. However, there are no comparable studies in children or adolescents. This study will determine whether CBT is effective in reducing a relapse of depressive episodes in children and adolescents with major depression.

This study comprises two phases. In Phase 1, all participants will receive drug treatment for 12 weeks. Participants who respond to the treatment will complete the study after 12 weeks. Participants whose depression symptoms return after 12 weeks will be enrolled in Phase 2. In Phase 2, participants will be randomly assigned to either continue drug therapy alone or to receive drug therapy plus CBT for 6 months. The CBT will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms. Self-report scales will be used to assess the depressive symptoms of participants who complete Phases 1 and 2 at study entry and at the end of the study.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
  • Clinical Global Impression severity score of 4 or greater
  • Children's Depression Rating Scale score of 40 or greater
  • Currently attending school
  • Willing and able to use acceptable methods of contraception, if applicable
  • In good general health
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • History of psychotic disorders
  • Alcohol or substance abuse or dependence within 6 months prior to study entry
  • History of anorexia nervosa or bulimia
  • Chronic medical illness requiring regular medication
  • Current use of medication with psychotropic effects
  • First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
  • At risk for suicide
  • Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
  • IQ less than 80
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response
Behavioral: Cognitive behavioral therapy (CBT)
CBT sessions will focus on teaching participants skills to manage depressed moods and to identify situations which might put them at risk for a relapse in depressive symptoms.
Drug: Drug therapy
All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
Other Names:
  • fluoxetine
Active Comparator: 2
Continuation phase drug therapy only for 6 more months following acute treatment response
Drug: Drug therapy
All participants will receive 12 weeks of treatment with antidepressant therapy. Responders to initial treatment will continue medication during the continuation phase (both treatment arms).
Other Names:
  • fluoxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse of depressive symptoms
Time Frame: Measured at Months 3 and 9
Measured at Months 3 and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Beth D. Kennard, PsyD, University of Texas, Southwestern Medical Center at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH072737 (U.S. NIH Grant/Contract)
  • DSIR 84-CTS (Division of Services and Intervention Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Cognitive behavioral therapy (CBT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe