Application and Evaluation of Group Cognitive Interventio... | NCT00946413

Studies
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents

NCT00946413

Sponsor

Taipei Medical University Hospital

Status

Completed

Last Update Posted

Jul 27, 2009Estimated

Enrollment

31Actual

Phase

Early Phase 1

Conditions

Community Adolescents at Risk for Depression and Suicide

Interventions

CBT plus parent education
CBT alone

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2009

Last Update Posted Date

Jul 27, 2009Estimated

Name	Class
Department of Health	AMBIG

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBT plus parent education	Experimental		Behavioral: CBT plus parent education
CBT alone	Experimental		Behavioral: CBT alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBT plus parent education	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol		6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hsiu-Ju Chang, phD	School of Nursing, Taipei Meidcal University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Nursing, Taipei Medical University		Taipei		110	Taiwan

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D013405	Suicide
D003117	Color Vision Defects
D003244	Consciousness Disorders

Ancestor Terms

ID	Term
D016728	Self-Injurious Behavior
D001526	Behavioral Symptoms
D001519	Behavior
D014786	Vision Disorders

Browse Leaves

Not provided

Browse Branches

Not provided