Cognitive Behavioral Therapy for Early-Onset Depression

Major Depressive Disorder Clinical Trial

Official title:

Comprehensive Treatment for Depressed Youth: An Outcome Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096642
• Other study ID #: CBT DEP
• Secondary ID: Ethics # 138/200
• Status: Completed
• Phase: N/A
• First received: November 12, 2004
• Last updated: August 4, 2011
• Start date: June 2002
• Est. completion date: June 2006

Study information

• Verified date: August 2011
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Depression is a debilitating illness affecting large numbers of young people. In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group. By studying the role of parental involvement, we hope to develop more effective treatments for depressed children and teens in the future.

Description:

Depression is a debilitating illness affecting large numbers of young people. Psychotherapy approaches have shown some promise in teens, but few studies have examined these interventions when offered in a group format. The role of parents in treatment outcome has also received little attention.

In this study, children and adolescents ages 10 to 17 meeting criteria for clinical depression will participate in a 15-session group therapy (cognitive behavioral therapy or CBT) that teaches strategies for overcoming depressed mood. For half the participants, their parents will also participate in a parent group to help them better manage their depressed children and teens. We will randomly assign children to CBT with or without parental involvement. We hope to show that involving parents results in additional improvements in the children. We will also study factors that predict which children do best in treatment, and maintenance of gains at 6 month and 1 year follow-up. These findings will allow us to provide more effective treatments to depressed children and teens in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children and adolescents meeting DSM-IV criteria for either Major Depression or Dysthymic Disorder.

Exclusion Criteria:

• Psychotic,

• Actively suicidal,

• IQ less than 80,

• Unable to speak English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Cognitive behaviour versus standard care

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Birmaher B, Brent DA, Kolko D, Baugher M, Bridge J, Holder D, Iyengar S, Ulloa RE. Clinical outcome after short-term psychotherapy for adolescents with major depressive disorder. Arch Gen Psychiatry. 2000 Jan;57(1):29-36. — View Citation

Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J, Dahl RE, Perel J, Nelson B. Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry. 1996 Nov;35(11):1427-39. Review. — View Citation

Birmaher B, Ryan ND, Williamson DE, Brent DA, Kaufman J. Childhood and adolescent depression: a review of the past 10 years. Part II. J Am Acad Child Adolesc Psychiatry. 1996 Dec;35(12):1575-83. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis on structured interview		pre and post-intervention	No
Primary	Children's Depression Inventory score		pre- and post-intervention	No
Secondary	Multidimensional Anxiety Scale for Children		pre- and post-intervention	No
Secondary	Children's Global Assessment Scale		pre- and post-intervention	No
Secondary	Brief Family Assessment Measure		pre- and post-intervention	No
Secondary	Perceived Competence Scale for Children		pre- and post-intervention	No

External Links

•   Website of American Academy of Child & Adolescent Psychiatry