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

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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

Email

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


Email

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

Email

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