UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047935 |
|---|---|
| Receipt number | R000054627 |
| Scientific Title | Investigating Mechanisms of Action of Mindfulness on PTSD Symptoms |
| Date of disclosure of the study information | 2022/06/02 |
| Last modified on | 2024/08/10 17:51:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigating Mechanisms of Action of Mindfulness on PTSD Symptoms
Acronym
Investigating Mechanisms of Action of Mindfulness on PTSD Symptoms
Scientific Title
Investigating Mechanisms of Action of Mindfulness on PTSD Symptoms
Scientific Title:Acronym
Investigating Mechanisms of Action of Mindfulness on PTSD Symptoms
Region
| Japan |
Condition
Condition
Posttraumatic Stress Disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the process by which mindfulness-based interventions affect the improvement of PTSD symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PTSD Checklist for DSM-5(screening, pre-intervention, mid-intervention, post-intervention, and follow-up)
Key secondary outcomes
Items asking about suicidal ideation , Items asking about trauma experience (screening, pre-intervention)
Self-rating Depression Scale(screening, pre-intervention, mid-intervention, post-intervention, and follow-up)
Items asking about stressful events since the last survey response, Mindful Attention Awareness Scale, Cognitive Fusion Questionnaire, Sheehan Disability Scale, Brief Version of the Posttraumatic Cognitions Inventory, Ways of Coping Check Lists-Revised(pre-intervention, mid-intervention, post-intervention, and follow-up)
Brief, Momentary mood Checklists(before and after each session)
Program comprehension(after each session)
Impressions(after each session, post-intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness training and defusion exercises
Interventions/Control_2
Mindfulness training
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
One month has passed since the "An event that continues to cause the same level of fear and discomfort as at the time of the experience." and he/she is still suffering from mental distress.
Key exclusion criteria
Those with suicidal ideation
Those who are currently undergoing or have undergone psychiatric or psychosomatic counseling.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Hyogo University of Teacher Education
Division name
Graduate School of Education
Zip code
650-0044
Address
Kobe Information Culture Building 3F,1-5-7 Higashikawasakicho, Chuo-ku, Kobe-shi, Hyogo
TEL
080-9459-8142
dito@hyogo-u.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Watanabe |
Organization
Hyogo University of Teacher Education
Division name
The Joint Graduate School (Ph.D. Program) in Science of School Education
Zip code
650-0044
Address
Kobe Information Culture Building 3F,1-5-7 Higashikawasakicho, Chuo-ku, Kobe-shi, Hyogo
TEL
080-9459-8142
Homepage URL
awatanabe.hyogo@gmail.com
Sponsor or person
Institute
Hyogo University of Teacher Education
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo University of Teacher Education
Address
942-1 Shimokume, Kato-shi, Hyogo
Tel
0795-44-2380
office-kenkyu-t@ml.hyogo-u.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
| 2022 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
https://hyogo-u.repo.nii.ac.jp/records/2000282
Publication of results
Published
Result
URL related to results and publications
https://hyogo-u.repo.nii.ac.jp/records/2000282
Number of participants that the trial has enrolled
30
Results
In order to examine the changes in each variable due to the intervention, a two-way analysis of variance was conducted for the two factors of group and time. As a result, the main effect of time was found in the scales measuring mindfulness awareness and attention, cognitive fusion, and PTSD, indicating that each of these improved and increased. On the other hand, there was no main effect of group or interaction for any of the scales.
Results date posted
| 2024 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
29 people (8 men, 20 women, 1 neither, average age of 22.93 (SD=6.85)) completed the experiment. There were 14 participants in the mindfulness group (5 males, 9 females, average age of 24.14 (SD=9.03)) and 15 participants in the defusion group (3 males, 11 females, 1 neither, average age of 21.80 (SD=3.47)). The types of traumatic experiences were interpersonal problems and the breakdown of relationships (19 people), setbacks and failures in schoolwork and education (2 people), sudden violent deaths (including attempted) (2 people), illnesses and injuries that involved the lives of others (1 person), bereavement (1 person), sexual victimization (1 person), and other (3 people).
Participant flow
Participants were recruited through application flyers. The application flyers contained a link to a questionnaire form for screening purposes. Those who responded to the questionnaire and met the selection criteria but not the exclusion criteria were contacted. Those who confirmed their willingness to participate were randomly assigned to each group. Participants attended the experimental program twice for 60 to 90 minutes. Of the 30 people who participated in the experiment, 29 completed it.
Adverse events
nothing
Outcome measures
PTSD Checklist for DSM-5 was used as the primary outcome measure. Secondary outcomes included items asking about suicidal ideation, items asking about trauma experiences, the Self-Rating Depression Scale, items asking about stressful events since the last survey, the Mindful Attention Awareness Scale, Cognitive Fusion Questionnaire, Sheehan Disability Scale, Brief Version of the Posttraumatic Cognitions Inventory, Ways of Coping Check Lists-Revised, Brief, Momentary mood Checklists, Program comprehension, and impressions were measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054627
