Application of the Web-based Acceptance and Commitment Therapy for Depression (ACTION)

October 13, 2024 updated by: Kyoung-Sae Na, Gachon University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyoung-Sae Na, MD, PhD
  • Phone Number: 82324689932
  • Email: ksna13@gmail.com

Study Locations

  • Korea, Republic of
    • Please Incheon
      • Incheon, Please Incheon, Korea, Republic of, 21565
        • Recruiting
        • Kyoung-Sae Na
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT
Web-based ACT with treatment as usual
Device: Web-based ACT
ACT program delivered online
Behavioral: Treatment as usual
Treatment as usual for major depressive disorder
Active Comparator: Controls
Waitlist being on the treatment as usual
Behavioral: Treatment as usual
Treatment as usual for major depressive disorder

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Fusion Questionnaire
Time Frame: 6 weeks
Cognitive fusion
6 weeks
Functional Connectivity
Time Frame: 6 weeks
functional connectivity of the brain during resting state
6 weeks
Valuing
Time Frame: 6 weeks
Measuring one's valuing
6 weeks
Beck Depression Inventory
Time Frame: 6 weeks
Measuring subjective depression
6 weeks
Beck Anxiety Inventory
Time Frame: 6 weeks
Measuring subjective anxiety
6 weeks
Beck Hopelessness Scale
Time Frame: 6 weeks
Measuring hopelessness by the Beck Hopelessness Scale
6 weeks
Beck Scale for Suicide Ideation
Time Frame: 6 weeks
Measuring suicidality
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GachonU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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