- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946413
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents
July 24, 2009 updated by: Taipei Medical University Hospital
Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression.
The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan.
It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Cognitive behavioral therapy (CBT) is well known for its active, directive, time-limited, and structured approach.
Despite an increasing prevalence of adolescent depression in Taiwan, few studies have been conducted to evaluate the immediate and long-term effectiveness of CBT for community-based adolescents at risk for depression and suicide.
Also, little is known about the effectiveness of the involvement of parents in CBT groups.
The Adolescent Coping with Depression Course (CWDA) (19) is an effective CBT-oriented group intervention for adolescent depression.
However, it has not been tested in specific cultural groups.
The primary purpose of this study was therefore to compare the immediate and long-term effectiveness of CBT alone, CBT with parental education, and control groups for community-based adolescents at risk for depression and suicide.A quasi-experimental research design was used in this study.
Community-based high school students at risk for depression and suicide were recruited and assigned to one of two experimental groups or a control group.
Students in the experimental groups received CBT plus parental education (group A, n = 9) or CBT alone (group B, n = 10).
The control group was designed as a waiting list group (group C, n = 12).
Both experimental groups received a follow-up session 1 year after the intervention.
Several outcome variables (depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness [LR], and salivary cortisol level) were used to determine the effectiveness of treatment.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 110
- School of Nursing, Taipei Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 19 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- willing to participate group assignment and grant consents
Exclusion Criteria:
- unwilling to participate potential group activity and grant consents
- severe physical or psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CBT plus parent education
|
The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations.
Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.
The issues taught and discussed included an introduction to adolescent depression and suicide, their etiology, symptoms, treatment, and prognosis, as well as stress management.
A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
|
EXPERIMENTAL: CBT alone
|
The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations.
Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol
Time Frame: 6
|
6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hsiu-Ju Chang, phD, School of Nursing, Taipei Meidcal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (ESTIMATE)
July 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 27, 2009
Last Update Submitted That Met QC Criteria
July 24, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOH95-TD-M-113-058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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