DepressionNCT04957680
Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
A study testing CCBT in people with Depression, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- CCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adolescents that scored above the threshold for mild depression (PHQ, CES-D)
Who cannot join
- adolescents with severe depression/neuropsychiatric conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyerim Kwon, +82-2-2072-4582, classic328@snu.ac.kr
About this study
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.
- Conditions
- Depression
- Being tested
- CCBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCBTBehavioural
computer-based treatment program for depressed adolescents
| Study group | Role | What they receive |
|---|---|---|
| computer-based cognitive behavioral therapy | Experimental | Not described Receives: Behavioral: CCBT |
| online stress management program | Active comparator | Not described Receives: Behavioral: CCBT |
| waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CES-D
Measured: 5 week
PHQ
Measured: 5 week
Secondary outcomes (8)
DSM-5 Severity measure for Depression, Child-Adolescent version
Measured: 5 week
Perceived Stress Scale
Measured: 5 week
Study Stress Scale
Measured: 5 week
BAI
Measured: 5 week
EPQ
Measured: 5 week
Self-esteem Scale
Measured: 5 week
PedsQL 4.0
Measured: 5 week
Homework compliance
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 Jun 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957680
- Sponsor's protocol ID
- KBN2021
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents
- ClinicalTrials.gov ID
- NCT04957680
- Acronym / sponsor ID
- KBN2021
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| computer-based cognitive behavioral therapy | Experimental | Behavioral: CCBT |
| online stress management program | Active comparator | Behavioral: CCBT |
| waitlist | No intervention | – |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- adolescents that scored above the threshold for mild depression (PHQ, CES-D)
Key exclusion criteria (1 listed)
- adolescents with severe depression/neuropsychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCBTcomputer-based treatment program for depressed adolescents | Behavioural | computer-based cognitive behavioral therapy, online stress management program |
Primary outcome
CES-D
Time frame: 5 week
PHQ
Time frame: 5 week
8 secondary outcomes
DSM-5 Severity measure for Depression, Child-Adolescent version
Time frame: 5 week
Perceived Stress Scale
Time frame: 5 week
Study Stress Scale
Time frame: 5 week
BAI
Time frame: 5 week
EPQ
Time frame: 5 week
Self-esteem Scale
Time frame: 5 week
PedsQL 4.0
Time frame: 5 week
Homework compliance
Time frame: 5 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCBT in people with Depression, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyerim Kwon (+82-2-2072-4582, classic328@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CES-D (time frame: 5 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.