UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058530 |
|---|---|
| Receipt number | R000066750 |
| Scientific Title | A Survey of participants in mindfulness-based cognitive therapy within a short-care psychiatric outpatient rehabilitation program. |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/21 10:17:34 |
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Basic information
Public title
A Survey of participants in mindfulness-based cognitive therapy within a short-care psychiatric outpatient rehabilitation program.
Acronym
A Survey of participants in mindfulness-based cognitive therapy within a short-care program.
Scientific Title
A Survey of participants in mindfulness-based cognitive therapy within a short-care psychiatric outpatient rehabilitation program.
Scientific Title:Acronym
A Survey of participants in mindfulness-based cognitive therapy within a short-care program.
Region
| Japan |
Condition
Condition
Participants in mindfulness-based cognitive therapy within a short-care psychiatric outpatient rehabilitation program.
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the actual conditions of participants in mindfulness-based cognitive therapy (MBCT) within a short-care psychiatric outpatient rehabilitation program.
Basic objectives2
Others
Basic objectives -Others
To exploratorily identify factors related to the short-term and long-term effects assessed by clinical scales, using univariate and multivariate analyses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participant demographics: age, sex, diagnosis, history of present illness, past medical history, marital status, years of education, employment and educational status.
Key secondary outcomes
1. Program attendance rate: Average number of sessions attended out of 8.
2. Study enrollment rate: Number of consented participants / Number of participants at the first short-care session.
3. Attrition rate: Number of dropouts / Number of study participants (Dropout criterion: fewer than 4 sessions attended).
4. Time spent on homework
5. Adverse Event Scale
6. Mean and standard deviation of the following clinical scales:
QIDS: Assessment for depressive symptoms.
GAD-7: Assessment for anxiety symptoms.
FFMQ, EQ: Assessment for mindfulness and decentering.
SWLS, FS: Assessment for well-being.
SPANE: Assessment for emotional well-being.
PSS: Assessment for perceived stress.
EQ-5D, ICECAP-A: Assessment for quality of life.
5.and 6. will be assessed five times:
T0: Before the program begins
T1: At the end of the 8th session
T2: 24 weeks after T0
T3: 48 weeks after T0
T4: 96 weeks after T0
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants are required to meet the following criteria among patients who visit the study institution during the research period:
1. Those who participate in short-care MBCT (mindfulness-based cognitive therapy).
2. Those who are able to complete questionnaires.
3. Those who understand the content of the study and provide written consent to participate.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University
Division name
Department of Neuropsychiatry, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0333531211
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2025 | Year | 07 | Month | 25 | 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
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Longitudinal observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066750
