UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042859 |
|---|---|
| Receipt number | R000048922 |
| Scientific Title | Nurse-led Mindfulness-Based Group Program Incorporating Psychoeducation About Rumination for Clients With Mental Disorders Presenting Depressive Symptoms: A Prospective Multicenter Controlled Trial in Clinical Daycare Settings |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2024/07/29 13:54:26 |
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Basic information
Public title
Evaluating the Effectiveness of the Nurse-led Mindfulness-Based Group Program
Acronym
Evaluating the Effectiveness of the Nurse-led Mindfulness-Based Group Program
Scientific Title
Nurse-led Mindfulness-Based Group Program Incorporating Psychoeducation About Rumination for Clients With Mental Disorders Presenting Depressive Symptoms: A Prospective Multicenter Controlled Trial in Clinical Daycare Settings
Scientific Title:Acronym
Nurse-led Mindfulness-Based Group Program Incorporating Psychoeducation About Rumination for Clients With Mental Disorders Presenting Depressive Symptoms: A Prospective Multicenter Controlled Trial in Clinical Daycare Settings
Region
| Japan |
Condition
Condition
Those with a psychiatrist's diagnosis of a mental disorder (codes F00-F99) listed in the International Classification of Diseases, Tenth Edition (ICD-10) as the primary diagnosis.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effectiveness of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rumination, Drop out
Key secondary outcomes
Cognitive Bias, Depression Symptoms, Adverse Events, The Level of Engagement with the Program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A participant takes part in the program (60 minutes each session, for a total of 8 sessions) and performs homework (the breathing method) every day in addition to receiving usual care.
Interventions/Control_2
usual care alone
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(a) having a primary diagnosis of mental disorders (codes F00-F99) listed in the International Classification of Diseases, 10th Revision (ICD-10)
(b) having at least mild severity of depressive symptoms based on a Quick Inventory of Depressive Symptomatology (QIDS) total score >= 6
(c) answering "yes" to the question "Have you ever experienced rumination (dwelling on past failures or unpleasant events)?"
(d) being at least 20 years old
Key exclusion criteria
(a) already engaging in daily mindfulness training
(b) currently undergoing structured psychotherapy (e.g., cognitive behavioral therapy)
(c) having a diagnosis of dementia, intellectual disability (moderate or above), or being at high risk of self-harm or harm to others
(d) being unable to obtain permission from a primary psychiatrist to participate in the study
(e) taking a high-level dose of antipsychotic medications (chlorpromazine equivalent of >= 1000 mg/d)
(f) having extremely severe depressive symptoms (QIDS score of >= 21)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Eguchi |
Organization
Kobe-Tokiwa University
Division name
Department of Nursing, Faculty of Health Science
Zip code
653-0838
Address
2-6-2Ootani-tyou nagata kobe
TEL
078-611-1821
m-eguchi@kobe-tokiwa.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Eguchi |
Organization
Kobe-Tokiwa University
Division name
Department of Nursing, Faculty of Health Science
Zip code
653-0838
Address
2-6-2Ootani-tyou nagata kobe
TEL
078-611-1821
Homepage URL
m-eguchi@kobe-tokiwa.ac.jp
Sponsor or person
Institute
Kobe-Tokiwa University
Institute
Department
Personal name
Funding Source
Organization
Kobe Tokiwa University
Grants Aid Scientific Research
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
Kobe-Tokiwa University
Address
281-1 Murei-cho Hara, Takamatsu City, Kagawa Prefecture, Japan 761-0123
Tel
087-870-1212
m-eguchi@kobe-tokiwa.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
| 2021 | Year | 03 | Month | 15 | 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
30
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2020 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048922
