Cognitive Behavioral Therapy for Depression Relapse Prevention in Children and Adolescents - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158301

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

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Continuation Phase CBT for Youth With MDD

Further study details as provided by National Institute of Mental Health (NIMH):

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
1: Experimental 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).
2: Active Comparator 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).

Arms

Assigned Interventions

1: Experimental

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).

2: Active Comparator

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).

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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Beth D. Kennard, PsyD

University of Texas Southwestern Medical Center at Dallas

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kennard BD, Emslie GJ, Mayes TL, Nightingale-Teresi J, Nakonezny PA, Hughes JL, Jones JM, Tao R, Stewart SM, Jarrett RB. Cognitive-behavioral therapy to prevent relapse in pediatric responders to pharmacotherapy for major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1395-404.

Responsible Party:	UT Southwestern Medical Center ( Beth Kennard, PsyD )
Study ID Numbers:	R34 MH72737, DSIR 84-CTS
Study First Received:	September 7, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00158301 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Child
Adolescent
CBT
Drug Therapy

Study placed in the following topic categories:

Fluoxetine
Depression
Mental Disorders
Mood Disorders

Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009