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

July 6, 2021 updated by: Seoul National University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • adolescents with severe depression/neuropsychiatric conditions

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: computer-based cognitive behavioral therapy
Behavioral: CCBT
computer-based treatment program for depressed adolescents
Active Comparator: online stress management program
Behavioral: CCBT
computer-based treatment program for depressed adolescents
No Intervention: waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CES-D
Time Frame: 5 week
5 week
PHQ
Time Frame: 5 week
5 week

Secondary Outcome Measures

Outcome Measure
Time Frame
DSM-5 Severity measure for Depression, Child-Adolescent version
Time Frame: 5 week
5 week
Perceived Stress Scale
Time Frame: 5 week
5 week
Study Stress Scale
Time Frame: 5 week
5 week
BAI
Time Frame: 5 week
5 week
EPQ
Time Frame: 5 week
5 week
Self-esteem Scale
Time Frame: 5 week
5 week
PedsQL 4.0
Time Frame: 5 week
5 week
Homework compliance
Time Frame: 5 week
5 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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 (Actual)

June 21, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBN2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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