NCT04957680

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 6, 2021

Last Update Submit

July 6, 2021

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • CES-D

    5 week

  • PHQ

    5 week

Secondary Outcomes (8)

  • DSM-5 Severity measure for Depression, Child-Adolescent version

    5 week

  • Perceived Stress Scale

    5 week

  • Study Stress Scale

    5 week

  • BAI

    5 week

  • EPQ

    5 week

  • +3 more secondary outcomes

Study Arms (3)

computer-based cognitive behavioral therapy

EXPERIMENTAL
Behavioral: CCBT

online stress management program

ACTIVE COMPARATOR
Behavioral: CCBT

waitlist

NO INTERVENTION

Interventions

CCBTBEHAVIORAL

computer-based treatment program for depressed adolescents

computer-based cognitive behavioral therapyonline stress management program

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • adolescents with severe depression/neuropsychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Hyerim Kwon

CONTACT

+82-2-2072-4582classic328@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 12, 2021

Study Start

June 21, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 12, 2021

Record last verified: 2021-07

Locations

KR(1)