UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032514
Receipt number R000037070
Scientific Title Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial
Date of disclosure of the study information 2018/05/08
Last modified on 2022/12/21 11:30:32

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Basic information

Public title

Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial

Acronym

Group CBT for dementia family caregivers

Scientific Title

Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial

Scientific Title:Acronym

Group CBT for dementia family caregivers

Region

Japan


Condition

Condition

Family Caregivers of Dementia

Classification by specialty

Neurology Psychosomatic Internal Medicine Psychiatry
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effectiveness of multi-component program based on cognitive behavioral therapy and positive psychology on psychological status, quality of life and caregiver burden of family caregivers of people with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hospital Anxiety and Depression Scale: HADS

Key secondary outcomes

Japanese version of Zarit Burden Index: J-ZBI-8
EuroQoL-5Dimension-5L: EQ-5D-5L
Japanese version of Caregiving Gratification Scale
Subjective Well-Being Scale
Neuropsychiatric Inventory Questionnaire: NPI-Q
the Japanese version of the Self-Compassionate Reactions Inventory; SCRI-J
Clinical Dementia Rating(CDR) and level of independnce of people with dementia


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Multi-component group intervention based on cognitive behavioral therapy and positive psychology (6 session, every two weeks)

Interventions/Control_2

wait-list control

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

1.Family caregiver of people with dementia
2.Communicable in Japanese
3.Written informed consent

Key exclusion criteria

Physical, psychiatric or cognitive disorders that hampers full commitment to the program

Target sample size

128


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Fujisawa

Organization

Keio University School of Medicine

Division name

Division of Patient Safety / Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3971

Email

dfujisawa@keio.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Tamura

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3971

Homepage URL


Email

tamura.n@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sakuragaoka Memorial Hospital
National Center of Neurology and Psychiatry
Tokyo Metropolitan Matsuzawa Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.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

慶應義塾大学病院(東京都)、桜ヶ丘記念病院(東京都)、国立精神・神経医療研究センター(東京都)、都立松沢病院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 08 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037070

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/psyg.12919

Number of participants that the trial has enrolled

64

Results

In the whole sample (n = 64), no significant effect was observed on HADS. There was medium effect on role strain (p = 0.04, partial eta2 = 0.08). Positive feelings increased after the intervention but were not maintained at follow-up. In the subgroup analysis of caregivers <65 years, a statistically significant effect was observed for personal strain (p = 0.03, partial eta2 = 0.16). Like the whole sample analysis, positive feelings increased after the intervention but were not maintained at follow-up.

Results date posted

2022 Year 12 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants
Average age: 64.9 years (SD: 12.4)
Male 28.6%, Female 71.4%
No significant difference in social background between the intervention group and the wail-list control group. The QOL was significantly higher in the intervention group.

Care recipients
Average age: 80.6 years (SD: 7.8)
Male 39.1%, Female 60.9%
Alzheimer's dementia: 76.2%
Home care: 90.6%
There was no significant difference in social and clinical background between the groups.

Participant flow

Participants were recruited and received informed consent at other related institutions. Sixty-four people who gave consent were randomized according to age(under 65, over 65) and caregiving status(at home or institutionalized).
The intervention group(n = 32) received six sessions(2 hours each) every 2 weeks. The wail-list control group(n=32) received a 10-week observation period and was invited to join the program after the study period.

Adverse events

No serious adverse event was observed.

Outcome measures

Assessments were conducted at three-time points: baseline, 10 weeks, 14 weeks.
Primary outcome: HADS (Hospital Anxiety and Depression Scale)
Secondary outcomes:
J-ZBI-8 (The Japanese version of the Zarit Burden Index-short version)
NPI-Q (Neuropsychiatric Inventory Questionnaire)
EQ-5D-5L (EuroQoL-5Dimension-5L)
DCPFS (Dementia Caregiver Positive Feeling Scale)
SWS (Subjective Well-Being Scale)
SCRI-J (Self Compassion Reaction Inventory)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 05 Month 08 Day

Date of IRB

2018 Year 05 Month 11 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2021 Year 06 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 08 Day

Last modified on

2022 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037070


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name