UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048957 |
|---|---|
| Receipt number | R000055779 |
| Scientific Title | Effectiveness of mindfulness based stress reduction program on positive emotions in adults: A single-arm pilot study |
| Date of disclosure of the study information | 2022/09/21 |
| Last modified on | 2024/03/30 15:19:46 |
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Basic information
Public title
Effects of a mindfulness based intervention on positive emotions
Acronym
Effects of a mindfulness based intervention on positive emotions
Scientific Title
Effectiveness of mindfulness based stress reduction program on positive emotions in adults: A single-arm pilot study
Scientific Title:Acronym
Effectiveness of mindfulness based stress reduction program on positive emotions in adults: A single-arm pilot study
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to investigate effectiveness of mindfulness based stress reduction (MBSR) program on improving positive emotions in adult community sample.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Dispositional Positive Emotion Scale
(pre-intervention, post-intervention, and 3-month follow-up)
Key secondary outcomes
Japanese version of the Self-Compassion Scale
Japanese version of the Five Facet Mindfulness Questionnaire
Japanese version of the Profile of Mood States 2nd Edition
Japanese version of the Satisfaction With Life Scale
Japanese version of the MOS 36-Item Short-Form Health Survey (SF-36v2)
(all outcomes will be assessed at pre-intervention, post-intervention, 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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness-based Stress Reduction
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Ability to give written consent to participate
(b)Available for interviews and questionnaires at pre, post intervention, and 3-month follow-up.
(c)Ability to attend one orientation session, eight sessions, and one silent retreat.
Key exclusion criteria
(a)History of previous mindfulness interventions
(b)Receiving medication or other psychotherapy for mental illness: Diagnosed and under treatment for substance related disorders, post-traumatic stress disorder, social anxiety disorder, panic disorder, hyperventilation syndrome, depressive disorder.
(c) Suicidal ideation
(d) Experienced a loss or sudden change in their lives, such as the recent death of a close relative
(e) Severe dementia
(f) Serious physical illness
(g) Any condition which the principal investigator judges to be unsuitable for participation in the research.
Target sample size
21
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 Ichibancho, Nishinomiya, Hyogo, Japan
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
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo, Japan
TEL
080-1361-9039
Homepage URL
caslstudies@gmail.com
Sponsor or person
Institute
KwanseiGakuin 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
Uegahara Ichiban, 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
| 2022 | Year | 09 | Month | 21 | 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
19
Results
The present study explored the effects of a mindfulness-based stress reduction (MBSR) program on improving positive affect in adults aged 18 to 65 years. 19 adults who met the participation criteria participated in two groups of MBSR. Finally, 9 completers were highly satisfied with MBSR, and the ANOVA showed that MBSR increased positive emotions and reduced fatigue. These results were consistent with the hypothesis, which was sufficient for a pilot study.
Results date posted
| 2024 | Year | 03 | Month | 30 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055779
