UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041874 |
|---|---|
| Receipt number | R000047130 |
| Scientific Title | Verification of the effectiveness of mindfulness based occupational therapy program for patients with depression and anxiety (Randomized controlled trial with waiting group as control group) |
| Date of disclosure of the study information | 2020/09/24 |
| Last modified on | 2023/09/26 17:00:13 |
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Basic information
Public title
Verification of the effectiveness of mindfulness based occupational therapy program for patients with depression and anxiety
(Randomized controlled trial with waiting group as control group)
Acronym
Verification of the effectiveness of MBOT for depression and anxiety disorder
Scientific Title
Verification of the effectiveness of mindfulness based occupational therapy program for patients with depression and anxiety
(Randomized controlled trial with waiting group as control group)
Scientific Title:Acronym
Verification of the effectiveness of MBOT for depression and anxiety disorder
Region
| Japan |
Condition
Condition
Depression
Anxiety disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of "Mindfulness-Based Occupational Therapy (MBOT)" on the recovery of patients with depression and anxiety.
Basic objectives2
Others
Basic objectives -Others
Recovery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese Version of the Questionnaire about the Process of Recovery
Key secondary outcomes
Clinical Global Impressions-severity Illness Scale
Hamilton Rating Scale for Depression
Quick Inventory of Depressive Symptomatology
State Trait Anxiety Inventory
Liebowitz Social Anxiety Scale
Social Adaptation Self-evaluation Scale
Five facet mindfulness questionnaire
NEO Five Factor Inventory
Digit Symbol Substitution Test
Continuous performance test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mindfulness based occupational therapy
90 min program
once a week for 8 weeks
Interventions/Control_2
Treatment as usual
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Persons aged 20 to 65 at the time of obtaining consent
2) Those who have been diagnosed with depression or anxiety disorder by DSM-5
3) Those whose pharmacotherapy has not changed within 1 month
4) Person who continues attending hospital for more than 3 months
5) Those who have a sufficient understanding of this research and have submitted their free written consent
Key exclusion criteria
1) Those who have participated in the Mindfulness Program for more than 8 weeks in the past
2) Persons with severe physical illness
3) In addition, those who the research director has determined to be inappropriate as a research target
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Medical University Medical Center
Division name
Psychiatry
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507
TEL
06-6992-1001
yamamoat@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Medical University Medical Center
Division name
Psychiatry
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507
TEL
06-6992-1001
Homepage URL
yamamoat@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant from the mental health Okamoto memorial foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Research Ethics Committee
Address
10-15 Fumizono-cho, Moriguchi, Osaka, 570-8507
Tel
06-6992-1001
rinriirb@hirakata.kmu.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
| 2020 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://karger.com/nps/article/doi/10.1159/000531487/854423/Effectiveness-and-Changes-in-Brain-Funct
Number of participants that the trial has enrolled
29
Results
This study showed that an eight weeks occupational therapy program incorporating mindfulness improved subjective well-being. The results of the main analysis revealed significant differences in the QPR questionnaire scores between the two groups. In the qEEG analysis, a significant increase in current source density in the beta2 band of the left DLPFC was observed in the MOT group compared to the control group.
Results date posted
| 2023 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047130
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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