UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042566 |
|---|---|
| Receipt number | R000048518 |
| Scientific Title | An Examination of the Psychological Effects of Loving-Kindness Meditation on PTSD : A Randomized Controlled Trial |
| Date of disclosure of the study information | 2020/11/27 |
| Last modified on | 2024/11/29 13:36:06 |
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Basic information
Public title
Loving-kindness Meditation for Posttraumatic Stress Disorder
Acronym
LKM for PTSD
Scientific Title
An Examination of the Psychological Effects of Loving-Kindness Meditation on PTSD : A Randomized Controlled Trial
Scientific Title:Acronym
RCT of LKM for PTSD
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder (PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the efficacy of an online 12-week intervention designed to improve positive affect via loving-kindness meditation for PTSD with a randomized control design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity 2) the PCL-5 total score and; 3) increased self-compassion and 4) positive affect in the intervention group compared to non-significant findings in the wait-list control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The clinical severity of PTSD symptoms measured by the ADIS-5 [ Time Frame: 0 - 3 - 6 - 12 month ]
Key secondary outcomes
1) The total score of the PCL-5 [ Time Frame: 0 - 3 - 6 - 12 month ]
2) The distress ratings of PTSD intrusion symptoms measured by the ADIS-5 [ Time Frame: 0 - 3 - 6 - 12 month ]
3) Improvements of PTSD symptoms measured by the Clinical Global Impressions Scale [ Time Frame: 0 - 3 - 6 - 12 month ]
4) Psychological indices: Self-Compassion Scale, CLS, FFMQ, PANAS, BDI-2, SWLS, DPES, SES, Social Connectedness Scale [ Time Frame: 0 - 3 - 6 - 12 month ]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 12-week Loving-kindness meditation program(weekly one hour group session, everyday homework)
Interventions/Control_2
A 12-week wait-list control(receiving the same 12-wwek LKM program after the waiting period)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years and older (Adult, Older Adult)
2) Primary diagnosis of PTSD (DSM-5 criteria; confirmed by ADIS-5)
3) Native Japanese speaker
4) Computer with internet access
Key exclusion criteria
(a) Severe substance use disorders (assessed by clinical interview)
(b)Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders (assessed by clinical interview)
(c)Actively considering plans of suicide or homicide (assessed by clinical interview)
(d)Severe physical disorders or cognitive disorders (dementia, severe traumatic Brain Injury)
(e) Ongoing psychiatric or psychological treatment for any psychological disorders
(f) Other relevant reason decided by the investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Sciences
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya
TEL
080-1361-9039
caslstudies@gmail.com
Public contact
Name of contact person
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Sciences
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya
TEL
080-1361-9039
Homepage URL
https://clinical-affective-science.org/LKM.html
caslstudies@gmail.com
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kwansei Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University
Address
2-1, Gakuen, Sanda, Hyogo, Japan, 669-1337
Tel
079-565-9052
med-ethic@kwansei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西学院大学文学部総合心理科学科および心理科学実践センター(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
54
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The data analyses including follow-up data has not been completed yet.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048518
