UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048554 |
|---|---|
| Receipt number | R000055322 |
| Scientific Title | Development of a novel self-COMPAssion focused online psyChoTherapy for the bereaved caregivers: COMPACT feasibility trial |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2024/02/01 09:07:12 |
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Basic information
Public title
Development of a novel self-COMPAssion focused online psyChoTherapy for the bereaved caregivers: COMPACT feasibility trial
Acronym
COMPACT feasibility trial
Scientific Title
Development of a novel self-COMPAssion focused online psyChoTherapy for the bereaved caregivers: COMPACT feasibility trial
Scientific Title:Acronym
COMPACT feasibility trial
Region
| Japan |
Condition
Condition
Grief
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the feasibility of online self-compassion focused psychotherapy for bereaved informal caregivers.
Basic objectives2
Others
Basic objectives -Others
n/a
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention completion rate
Key secondary outcomes
Satisfaction, Consent of enrolment, Attrition, Survey response Post-session work submission, Complicated Grief Questionnaire, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Brief Resilience Scale and Self-Compassion Scale.
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
| Other |
Interventions/Control_1
Participants will undergo an intervention programme comprising online sessions of two hours per week for five consecutive weeks and undertake post-session work.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria of the study participants are as follows: (1) informal caregivers, over 18 years of age, who lost a loved one more than 6 months ago; (2) people who can continue to participate in the online sessions and practice self-compassion improvement post-session work by themselves ; (3) people who can use smartphones or PCs with a stable internet connection, with or without the support from others.
Key exclusion criteria
Exclusion criteria comprise: (1) people currently receiving psychiatric treatment (excluding cases the psychiatrist deems fit for participation in this study); (2) people judged to be unsuitable for participation in this research by one of the researchers due to physical, mental, or cognitive problems (e.g., respiratory disease, dementia, serious past traumatic experience of bereavement etc.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
TEL
0757513518
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Uneno |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
TEL
0757513518
Homepage URL
https://compact-trial.com/
yuuneno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
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
Kyoto University Hospital
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
Tel
075-751-4748
ethcom@kuhp.kyoto-u.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 | 02 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36549732/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
Results
currently being tracked
Results date posted
| 2023 | Year | 08 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055322
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
