Application of the Web-based Acceptance and Commitment Th... | NCT06293781

Studies
Application of the Web-based Acceptance and Commitment Therapy for Depression

NCT06293781

Sponsor

Gachon University

Status

Unknown status

Last Update Posted

Oct 16, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Major Depressive Disorder

Interventions

Web-based ACT
Treatment as usual

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2022Actual

Primary Completion Date

Feb 28, 2025Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Feb 18, 2024

First Submission Date that Met QC Criteria

Feb 27, 2024

First Posted Date

Mar 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2024

Last Update Posted Date

Oct 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACT	Experimental	Web-based ACT with treatment as usual	Device: Web-based ACT Behavioral: Treatment as usual
Controls	Active Comparator	Waitlist being on the treatment as usual	Behavioral: Treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Web-based ACT	Device	ACT program delivered online	ACT
Treatment as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptance and Action Questionnaire-II	Psychological flexibility	6 weeks
Hamilton Rating Scale for Depression	Interviewer-rated depression scale	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cognitive Fusion Questionnaire	Cognitive fusion	6 weeks
Functional Connectivity	functional connectivity of the brain during resting state

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who diagnosed major depressive disorder

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyoung-Sae Na, MD, PhD	Contact	82324689932		ksna13@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyoung-Sae Na	Recruiting	Incheon	Please Incheon	21565	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided