Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents

The University of Texas System (UT)

Status

Completed

Conditions

Depression

Treatments

Drug: Drug therapy

Behavioral: Cognitive behavioral therapy (CBT)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00158301

DSIR 84-CTS

R34MH072737 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

72 patients

Sex

All

Ages

11 to 18 years old

Volunteers

No Healthy Volunteers

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