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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Grief | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |