UMIN-CTR Clinical Trial

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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