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Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents

Primary Purpose

Community Adolescents at Risk for Depression and Suicide

Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
CBT plus parent education
CBT alone
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Community Adolescents at Risk for Depression and Suicide focused on measuring CBT, Depressed and suicidal adolescents

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Nursing, Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBT plus parent education

CBT alone

Arm Description

Outcomes

Primary Outcome Measures

depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol

Secondary Outcome Measures

Full Information

First Posted
July 24, 2009
Last Updated
July 24, 2009
Sponsor
Taipei Medical University Hospital
Collaborators
Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT00946413
Brief Title
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents
Official Title
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University Hospital
Collaborators
Department of Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Adolescents at Risk for Depression and Suicide
Keywords
CBT, Depressed and suicidal adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT plus parent education
Arm Type
Experimental
Arm Title
CBT alone
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CBT plus parent education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol
Time Frame
6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Ju Chang, phD
Organizational Affiliation
School of Nursing, Taipei Meidcal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.cachildwelfareclearinghouse.org/program/127/detailed#relevant-research
Description
Related Info

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Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents

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