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
CRIS Registration Number |
KCT0005491 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 4 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korean Neuropsychiatric Research Foundation |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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) |
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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)
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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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