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Acceptance and commitment therapy for destructive experiential avoidance (ACT-DEA): a pilot study

Status Approved

  • First Submitted Date

    2020/09/16

  • Registered Date

    2020/10/15

  • Last Updated Date

    2020/10/07

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005491
    Unique Protocol ID KNUH-A-2019-08-005-001
    Public/Brief Title Acceptance and commitment therapy for destructive experiential avoidance (ACT-DEA): a pilot study
    Scientific Title Acceptance and commitment therapy for destructive experiential avoidance (ACT-DEA): a pilot study
    Acronym ACT-DEA
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNUH-A-2019-08-005-001
    Approval Date 2019-09-09
    Institutional Review Board Name Kangwon National University Hospital Institutional Review Board
    Institutional Review Board Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do
    Institutional Review Board Telephone 033-258-9199
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kanguk Lee
    Title M.D., Ph.D.
    Telephone +82-33-250-7822
    Affiliation Kangwon National University Hospital
    Address Department of Psychiatry, Kangwon National University Hospital, 156, Baengnyeong-ro, Chuncheon, Republic of Korea
    Contact Person for Public Queries
    Name Euihyeon Na
    Title M.D., Ph.D.
    Telephone +82-63-230-1559
    Affiliation Presbyterian Medical Center
    Address Department of Neuropsychiatry, Presbyterian Medical Center, 365, Seowon-ro, Wansan-gu, Jeonju, Republic of Korea
    Contact Person for Updating Information
    Name Euihyeon Na
    Title M.D., Ph.D.
    Telephone +82-63-230-1559
    Affiliation Presbyterian Medical Center
    Address Department of Neuropsychiatry, Presbyterian Medical Center, 365, Seowon-ro, Wansan-gu, Jeonju, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 4
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-09-10 Actual
    Target Number of Participant 30
    Primary Completion Date 2020-08-24 , Actual
    Study Completion Date 2020-08-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kangwon National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-09-19 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Chamsarang Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-09-10 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Heart and Heart Mental Clinic
    Recruitment Status Completed
    Date of First Enrollment 2019-09-28 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Maumgonggam Psychiatric Clinic
    Recruitment Status Completed
    Date of First Enrollment 2019-09-28 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korean Neuropsychiatric Research Foundation
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kangwon National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Experiential avoidance has been defined as attempts to avoid and/or escape from aversive private events such as thoughts and feelings. Further, evidence demonstrates that destructive experiential avoidance (DEA), including deliberate self-harm, excessive substance use, and aggressive behavior, leads to transdiagnostic negative consequences for mental health. The aim of this study is to develop a novel behavioral intervention based on Acceptance and Commitment Therapy (ACT) to reduce destructive experiential avoidance and improve mental health. In addition, this study examines the feasibility of using the ACT program for destructive experiential avoidance (ACT-DEA) in a sample of adolescents in Korea.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Behavioral  
    Intervention Description
    The Acceptance and commitment therapy (ACT) intervention will consist of 6 weekly individual sessions of 40-minutes each and pharmacological treatment. The treatment as usual (TAU) will consist of accepted standards including psychotherapy and medication.
    Number of Arms 2
    Arm 1

    Arm Label

    Acceptance and commitment therapy (ACT) group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    The Acceptance and commitment therapy (ACT) intervention will consist of 6 weekly individual sessions of 40-minutes each.
    Arm 2

    Arm Label

    Treatment as usual (TAU) group

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    The treatment as usual (TAU) will consist of accepted standards including psychotherapy and medication.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F60.6)Anxious[avoidant] personality disorder 

    Destructive Experiential Avoidance (Deliberate Self-harm; Excessive alcohol and/or drug use; Binge and/or restrictive eating; Sexual promiscuity; Excessive internet and/or computer game use; Aggression)
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    15Year~25Year

    Description

    Adolescents (aged 15-25 years) who had destructive experiential avoidant behaviors within the previous 3 months
    Exclusion Criteria
    1. Current moderate to high suicide risk
    2. Severely acute phase of mental illness 
    3. History of brain injury and/or organic mental disease
    4. Suspected of intellectual disability
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Frequency of Destructive Experiential Avoidance
    Timepoint
    1 week following the last session
    Primary Outcome(s) 2
    Outcome
    Brief form of Multidimensional Experiential Avoidance Questionnaire (K-MEAQ-24)
    Timepoint
    1 week following the last session
    Secondary Outcome(s) 1
    Outcome
    Patient Health Questionnaire-9 (PHQ-9)
    Timepoint
    1 week following the last session
    Secondary Outcome(s) 2
    Outcome
    General Anxiety Disorder-7 (GAD-7)
    Timepoint
    1 week following the last session
    Secondary Outcome(s) 3
    Outcome
    WHO Quality of Life-BREF (WHOQOL-BREF)
    Timepoint
    1 week following the last session
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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