Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Cognitive behavioral therapy (CBT); Drug: Drug therapy

• Registration Number: NCT00158301
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2007-11
• Study Completion: 2008-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive behavioral therapy (CBT)	Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response
1	Drug therapy	Continuation phase cognitive behavioral therapy and drug therapy for 6 more months following acute treatment response
2	Drug therapy	Continuation phase drug therapy only for 6 more months following acute treatment response

Primary Outcome Measures

Name	Time	Method
Relapse of depressive symptoms	Measured at Months 3 and 9

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States