NCT06293781

Brief Summary

PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 19, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

October 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 18, 2024

Last Update Submit

October 13, 2024

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • Acceptance and Action Questionnaire-II

    Psychological flexibility

    6 weeks

  • Hamilton Rating Scale for Depression

    Interviewer-rated depression scale

    6 weeks

Secondary Outcomes (7)

  • Cognitive Fusion Questionnaire

    6 weeks

  • Functional Connectivity

    6 weeks

  • Valuing

    6 weeks

  • Beck Depression Inventory

    6 weeks

  • Beck Anxiety Inventory

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

ACT

EXPERIMENTAL

Web-based ACT with treatment as usual

Device: Web-based ACTBehavioral: Treatment as usual

Controls

ACTIVE COMPARATOR

Waitlist being on the treatment as usual

Behavioral: Treatment as usual

Interventions

Web-based ACTDEVICE

ACT program delivered online

ACT
Treatment as usualBEHAVIORAL

Treatment as usual for major depressive disorder

ACTControls

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who diagnosed major depressive disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoung-Sae Na

Incheon, Please Incheon, 21565, South Korea

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Kyoung-Sae Na, MD, PhD

CONTACT

82324689932ksna13@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 18, 2024

First Posted

March 5, 2024

Study Start

December 19, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

October 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)