UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054144 |
|---|---|
| Receipt number | R000061827 |
| Scientific Title | An Examination of the Psychological Effects of Loving-Kindness Meditation on PTSD : A Single Arm Pilot Study |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/13 19:06:32 |
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Basic information
Public title
Loving-kindness Meditation for Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder
Acronym
LKM for PTSD and CPTSD
Scientific Title
An Examination of the Psychological Effects of Loving-Kindness Meditation on PTSD : A Single Arm Pilot Study
Scientific Title:Acronym
A single arm pilot study of LKM for PTSD and CPTSD
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety and efficacy of an online 12-week intervention designed to improve positive affect via loving-kindness meditation for PTSD and CPTD symptoms with a single arm design. It is hypothesized that clinically significant reductions of: 1) PTSD and CPTSD total symptom severity 2) the PCL-5 total score and; 3) increased self-compassion and 4) positive affect before and after intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total score of the ITQ [ Time Frame: pre, post, and 3 month follow-up ]
Key secondary outcomes
1) The severity ratings of PTSD intrusion symptoms by the Clinical Global Impressions Scale - Severity. [ Time Frame: pre, post, and 3 month follow-up ]
2) Improvements of PTSD symptoms measured by the Clinical Global Impressions -Improvement. [ Time Frame: pre, post, and 3 month follow-up ]
3) The total score of the PCL-5. [ Time Frame: pre, post, and 3 month follow-up ]
4) Psychological indices: Self-compassion Scale, Self-esteem scale, Watts Connectedness Scale, Nondual Awareness Dimensional Assessment, Five Facet Mindfulness Questionnaire, Satisfaction With Life Scale, Dispositional Positive Emotion Scale, and DASS 21. [ Time Frame: pre, post, and 3 month follow-up ]
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A 12-week loving-kindness meditation program(weekly one and half hour group session, everyday homework)
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adult between 18 and 75 years
2) Primary diagnosis of PTSD or CPTD (ICD-11 criteria; confirmed by ADIS-5 and ITI)
3) Native Japanese speaker
4) Computer with internet access
Key exclusion criteria
(a) Experienced intervention with meditation practices
(b) Severe substance use disorders, 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) No permission from their physician or psychologist for any psychological problems
(f) Other relevant reason decided by the investigators
Target sample size
27
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 Science
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo
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 Science
Zip code
663-8204
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo
TEL
080-1361-9039
Homepage URL
caslstudies@gmail.com
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Kohki Arimitsu. Ph.D
Funding Source
Organization
Grants-in-Aid for Scientific Research-KAKENHI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kwansei Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University
Address
1, Gakuen Uegahara, Sanda, Hyogo
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061827
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