Major Depressive DisorderACTIONNCT06293781
Application of the Web-based Acceptance and Commitment Therapy for Depression
A study testing Web-based ACT and Treatment as usual in people with Major Depressive Disorder, run by Gachon University at 1 site in South Korea.
Trial summary
PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Web-based ACT and Treatment as usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Dec 2022to 28 Feb 2025
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who diagnosed major depressive disorder
Who cannot join
- Patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease
- Women who were pregnant or nursing
- Patients at high risk for suicide
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyoung-Sae Na
Incheon, Please Incheon, 21565
Kyoung-Sae Na, MD, PhD, 82324689932, ksna13@gmail.com
About this study
Official title: The Efficacy and Treatment Mechanisms of the Web-based Acceptance and Commitment Therapy for Patients with Major Depressive Disorder
PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY
Read the detailed description
Acceptance Commitment Therapy (ACT) is known to help people recover from depression by improving psychological flexibility through acceptance, defusion, self-as-context, present moment, committed action, and helping them live a values-based life. This study is a randomized controlled trial to determine if web-based ACT leads to changes in the psychological flexibility and cognitive fusion. Also, through the functional MRI study, possible treatment mechanisms by which the web-based ACT exerts will be identified.
- Conditions
- Major Depressive Disorder
- Being tested
- Web-based ACT, Treatment as usual
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based ACTDevice
ACT program delivered online
Treatment as usualBehavioural
Treatment as usual for major depressive disorder
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Web-based ACT with treatment as usual Receives: Device: Web-based ACT; Behavioral: Treatment as usual |
| Controls | Active comparator | Waitlist being on the treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and Action Questionnaire-II
Psychological flexibility
Measured: 6 weeks
Hamilton Rating Scale for Depression
Interviewer-rated depression scale
Measured: 6 weeks
Secondary outcomes (7)
Cognitive Fusion Questionnaire
Cognitive fusion
Measured: 6 weeks
Functional Connectivity
functional connectivity of the brain during resting state
Measured: 6 weeks
Valuing
Measuring one's valuing
Measured: 6 weeks
Beck Depression Inventory
Measuring subjective depression
Measured: 6 weeks
Beck Anxiety Inventory
Measuring subjective anxiety
Measured: 6 weeks
Beck Hopelessness Scale
Measuring hopelessness by the Beck Hopelessness Scale
Measured: 6 weeks
Beck Scale for Suicide Ideation
Measuring suicidality
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start19 Dec 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung-Sae Na, Gachon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293781
- Sponsor's protocol ID
- GachonU
- Acronym
- ACTION
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Treatment Mechanisms of the Web-based Acceptance and Commitment Therapy for Patients with Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06293781
- Acronym / sponsor ID
- ACTION / GachonU
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gachon UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY
Detailed description
Acceptance Commitment Therapy (ACT) is known to help people recover from depression by improving psychological flexibility through acceptance, defusion, self-as-context, present moment, committed action, and helping them live a values-based life. This study is a randomized controlled trial to determine if web-based ACT leads to changes in the psychological flexibility and cognitive fusion. Also, through the functional MRI study, possible treatment mechanisms by which the web-based ACT exerts will be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Device: Web-based ACT, Behavioral: Treatment as usualWeb-based ACT with treatment as usual |
| Controls | Active comparator | Behavioral: Treatment as usualWaitlist being on the treatment as usual |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who diagnosed major depressive disorder
Key exclusion criteria (3 listed)
- Patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease
- Women who were pregnant or nursing
- Patients at high risk for suicide
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 |
|---|---|---|
| Web-based ACTACT program delivered online | Device | ACT |
| Treatment as usualTreatment as usual for major depressive disorder | Behavioural | ACT, Controls |
Primary outcome
Acceptance and Action Questionnaire-II
Time frame: 6 weeks
Psychological flexibility
Hamilton Rating Scale for Depression
Time frame: 6 weeks
Interviewer-rated depression scale
7 secondary outcomes
Cognitive Fusion Questionnaire
Time frame: 6 weeks
Functional Connectivity
Time frame: 6 weeks
Valuing
Time frame: 6 weeks
Beck Depression Inventory
Time frame: 6 weeks
Beck Anxiety Inventory
Time frame: 6 weeks
Beck Hopelessness Scale
Time frame: 6 weeks
Beck Scale for Suicide Ideation
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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 Web-based ACT and Treatment as usual in people with Major Depressive Disorder, run by Gachon University 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 3 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 16 Oct 2024. 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 Kyoung-Sae Na, MD, PhD (82324689932, ksna13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire-II (time frame: 6 weeks). 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 16 Oct 2024.