Cognitive Behavioral Therapy for Early-Onset Depression

NCT ID: NCT00096642

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Dysthymic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioral Therapy

Cognitive behaviour versus standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Centre for Addiction and Mental Health

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katharina Manassis, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1097/00004583-199611000-00011.

Reference Type BACKGROUND
PMID: 8936909 (View on PubMed)

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. doi: 10.1097/00004583-199612000-00008.

Reference Type BACKGROUND
PMID: 8973063 (View on PubMed)

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. doi: 10.1001/archpsyc.57.1.29.

Reference Type BACKGROUND
PMID: 10632230 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.aacap.org

Website of American Academy of Child \& Adolescent Psychiatry

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ethics # 138/2001

Identifier Type: -

Identifier Source: secondary_id

CBT DEP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.