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Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CCBT
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adolescents that scored above the threshold for mild depression (PHQ, CES-D)

Exclusion Criteria:

  • adolescents with severe depression/neuropsychiatric conditions

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

computer-based cognitive behavioral therapy

online stress management program

waitlist

Arm Description

Outcomes

Primary Outcome Measures

CES-D
PHQ

Secondary Outcome Measures

DSM-5 Severity measure for Depression, Child-Adolescent version
Perceived Stress Scale
Study Stress Scale
BAI
EPQ
Self-esteem Scale
PedsQL 4.0
Homework compliance

Full Information

First Posted
July 6, 2021
Last Updated
July 6, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04957680
Brief Title
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
Official Title
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effectiveness of a computer-based Cognitive Behavioral Therapy (CCBT) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
computer-based cognitive behavioral therapy
Arm Type
Experimental
Arm Title
online stress management program
Arm Type
Active Comparator
Arm Title
waitlist
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CCBT
Intervention Description
computer-based treatment program for depressed adolescents
Primary Outcome Measure Information:
Title
CES-D
Time Frame
5 week
Title
PHQ
Time Frame
5 week
Secondary Outcome Measure Information:
Title
DSM-5 Severity measure for Depression, Child-Adolescent version
Time Frame
5 week
Title
Perceived Stress Scale
Time Frame
5 week
Title
Study Stress Scale
Time Frame
5 week
Title
BAI
Time Frame
5 week
Title
EPQ
Time Frame
5 week
Title
Self-esteem Scale
Time Frame
5 week
Title
PedsQL 4.0
Time Frame
5 week
Title
Homework compliance
Time Frame
5 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adolescents that scored above the threshold for mild depression (PHQ, CES-D) Exclusion Criteria: adolescents with severe depression/neuropsychiatric conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyerim Kwon
Phone
+82-2-2072-4582
Email
classic328@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyerim Kwon
Phone
+82-2-2072-4582
Email
classic328@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents

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