Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00158301
First received: September 7, 2005
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Depression
Behavioral: Cognitive behavioral therapy (CBT)
Drug: Drug therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Continuation Phase CBT for Youth With MDD

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Relapse of depressive symptoms [ Time Frame: Measured at Months 3 and 9 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: fluoxetine

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158301

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Beth D. Kennard, PsyD University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beth Kennard, PsyD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00158301     History of Changes
Other Study ID Numbers: R34 MH72737, R34MH072737, DSIR 84-CTS
Study First Received: September 7, 2005
Last Updated: November 7, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Child
Adolescent
CBT
Drug Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014