UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048657 |
|---|---|
| Receipt number | R000055443 |
| Scientific Title | Feasibility study of a mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work. |
| Date of disclosure of the study information | 2022/08/13 |
| Last modified on | 2026/01/04 23:28:30 |
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Basic information
Public title
Feasibility study of a mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work.
Acronym
Feasibility study of a mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work.
Scientific Title
Feasibility study of a mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work.
Scientific Title:Acronym
Feasibility study of a mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work.
Region
| Japan |
Condition
Condition
depression disorders
anxiety disorders
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test feasibility of mindfulness-based a Recovery support program for psychiatry day treatments users with Return-to-work.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(Baseline and 8weeks after starting intervention)
Recovery Assessment Scale (RAS)
Key secondary outcomes
(Baseline and 8weeks after starting intervention)
Drop-out rates
Five Facet Mindfulness Questionnaire
The Center for Epidemiologic Studies Depression Scale
State-Trait Anxiety Inventory
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
| Behavior,custom |
Interventions/Control_1
mindfulness-based a Recovery support program
/mindfulness based cognitive therapy
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed as depression disorder, anxiety disorder and using day treatments with return-to-work
Ability to consent in writing
Key exclusion criteria
Unsuitable for participation in the research in the opinion of the day treatment staff
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Midorikawa |
Organization
Graduate School of Medicine, The Jikei University
Division name
Doctoral program in Nursing
Zip code
105-8461
Address
3-25-8 Nishi-shinbashi, Minato-ku,Tokyo
TEL
+81-(0)3-3433-1111
midomido@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Midorikawa |
Organization
Graduate School of Medicine, The Jikei University
Division name
Doctoral program in Nursing
Zip code
105-8461
Address
3-25-8 Nishi-shinbashi, Minato-ku,Tokyo
TEL
+81-(0)3-3433-1111
Homepage URL
midomido@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
Yamaji Fumiko Professional Nursing Education Scholarship
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
The Jikei University
Address
3-25-8 Nishi-shinbashi, Minato-ku,Tokyo
Tel
+81-(0)3-3433-1111
rinri@jikei.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 | 08 | Month | 13 | 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
15
Results
13 out of 15 participants completed the program, resulting in a dropout rate of 13.3%. Pre- and post-intervention comparisons revealed significant improvement in the primary outcome measure, RAS (p = .002, r = 0.82). Additionally, significant improvements were observed in FFMQ (p = .027, r = 0.57), CES-D (p = .023, r = 0.59), STAI-S (p = .035, r = 0.54), and STAI-T (p = .009, r = 0.68), all showing large effect sizes (r > 0.5).
Results date posted
| 2026 | Year | 01 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Research progress has been delayed overall due to the impact of COVID-19. Furthermore, the analysis of data is behind schedule, causing delays in the publication of results.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055443
