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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048554
Receipt No. 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 2022/08/02

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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 6 months to 3 years 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
Email 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/
Email yuuneno@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
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
2022 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2023 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 02 Day
Last modified on
2022 Year 08 Month 02 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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