- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898413
Group-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia in Japan
December 7, 2023 updated by: Hiroshi Morimoto, Meiji Gakuin University
Group-based Acceptance and Commitment Therapy and Group-based Cognitive Behavior Therapy for Family Caregivers of People With Dementia in Japan
Along with more people worldwide having dementia, the number of people with dementia and their family caregivers have increased in Japan.
However, psychological support for family caregivers of people with dementia is still limited in Japan.
The purpose of this pilot study is to examine feasibility and preliminary efficacy of a group-based acceptance and commitment therapy (ACT) for family caregivers of people with dementia in Japan compared to a group-based cognitive behavior therapy (CBT).
This study also preliminarily examines the efficacy of combining psychological intervention for family caregivers (group-based ACT/CBT) with psychological intervention for their care recipients (group-based reminiscence therapy).
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study employs quasi-experimental design to investigate the feasibility and preliminary efficacy of the group-based ACT for family caregivers of people with dementia compared to the group-based CBT.
Both interventions consist of eight sessions, each lasting about 90 minutes, through face-to-face or Zoom video conferencing over the course of four months.
Family caregivers will be assigned to either the ACT or CBT interventions.
Pre-, post-intervention, and 6 month follow-up measurements assess depression, anxiety, quality of life, cognitive appraisal of caregiving (i.e., subjective burden and positive aspect of caregiving), possible process factors (i.e., caregiving self-efficacy, experiential avoidance, and commitment), care recipients' behavioral and psychological symptoms of dementia (BPSD), and so on.
This study also preliminarily examines the efficacy of combining psychological intervention for family caregivers (i.e., the group-based ACT/CBT) with those for their care recipients (i.e., group-based reminiscence therapy).
The group-based reminiscence therapy will be held once or twice a month, each lasting about 60-90 minutes, over the course of about three months.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
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Minato-Ku, Tokyo, Japan, 108-8636
- Recruiting
- Meiji Gakuin University
-
Contact:
- Hiroshi Morimoto, Ph.D
- Phone Number: +81-3-5421-5305
- Email: hmori@psy.meijigakuin.ac.jp
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Principal Investigator:
- Hiroshi Morimoto, Ph.D
-
Sub-Investigator:
- Nobutake Nomura, Ph.D
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Sub-Investigator:
- Takashi Muto, Ph.D
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Family caregivers:
- providing care for a family member with dementia or mild cognitive impairment
- being able to speak and read Japanese
- being 20 years of age or older.
Care recipients (group-based reminiscence therapy):
- having a clear intention to participate in the intervention
- being able to speak Japanese
- being diagnosed with mild cognitive impairment or mild stage of dementia and MoCA scores ≥ 11
- obtaining consent from their family caregiver and their doctor to participate in the intervention.
Exclusion Criteria:
Family caregivers:
- having psychiatric disorder at the time of participation in the intervention.
Care recipients (group-based reminiscence therapy):
- having insufficient capacity to give consent to participate in the intervention
- being diagnosed with moderate to severe stage of dementia or MoCA scores < 11.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group-based acceptance and commitment therapy (ACT)
Participants assigned to the group-based ACT intervention will receive eight sessions through face-to-face or Zoom video conferencing over the course of four months.
Participants will also receive individualized support between sessions to help them better understand the program using phone or Zoom video conferencing.
If participants' care recipient hopes to receive psychological treatment, they will be invited to participate in a group-based reminiscence therapy held once or twice a month, each lasting about 60-90 minutes, over the course of about three months.
|
Group-based ACT intervention by professional psychotherapist consists of four modules: (a) psychoeducation about dementia and experiential avoidance in caregiving, (b)mindfulness and acceptance of aversive emotions, sensations, and thoughts, (c) behavior management for care recipients' BPSD, and (d) clarifying and choosing one's value, and taking actions toward the chosen values.
Each session lasts about 90 minutes and will be held every two weeks.
Group-based reminiscence therapy for care recipients will be conducted by a professional psychotherapist other than the one conducting group-based ACT intervention.
|
Active Comparator: Group-based cognitive behavior therapy (CBT)
Participants assigned to the group-based CBT intervention will receive eight sessions through face-to-face or Zoom video conferencing over the course of four months.
Participants will also receive individualized support between sessions to help them better understand the program using phone or Zoom video conferencing.
If participants' care recipient hopes to receive psychological treatment, they will be invited to participate in a group-based reminiscence therapy held once or twice a month, each lasting about 60-90 minutes, over the course of about three months.
|
Group-based CBT intervention by professional psychotherapist consists of four modules: (a) psychoeducation about dementia and distress in caregiving, (b) cognitive restructuring and relaxation, (c) behavior management for care recipients' BPSD, and (d) increasing pleasant activities.
Each session lasts about 90 minutes and will be held every two weeks.
Group-based reminiscence therapy for care recipients will be conducted by a professional psychotherapist other than the one conducting group-based CBT intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline depression and anxiety at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the Hospital Anxiety and Depression Scale.
This scale comprises two seven-item subscales: depression and anxiety.
Scale scores range from 0 to 21 for each subscale, where higher scores indicate worse outcome.
|
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Change from baseline quality of life (QOL) at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the WHOQOL26.
This scale comprises 26 items on four subscales: physical domain, psychological domain, social relationships, environment, and general health/QOL.
Scale scores range from 7 to 35 for physical domain, 6 to 30 for psychological domain, 3 to 15 for social relationships, 8 to 40 for environment, and 2 to 10 for general health/QOL.
Higher scores indicate better outcome.
|
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline subjective burden at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the Zarit Burden Interview.
This scale comprises 22 items, ranging from 0 to 88.
Higher scores indicate worse outcome.
|
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Change from baseline positive aspects of caregiving at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Measured by the Cognitive Caregiving Appraisal Scale.
This scale comprises 26 items on three negative appraisal subscales (feelings of restriction of social life, anxiety about continuing caregiving, and distress of the relationships with others) and three positive appraisal subscales (fulfillment of caregiving roles, affection toward the caretakers, and self-growth by caregiving).
Positive appraisal subscales are used.
Scale scores range from 6 to 24 for fulfillment of caregiving roles, 4 to 16 for affection toward the caretakers, and 3 to 12 for self-growth by caregiving.
Higher scores indicate better outcome.
|
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Change from baseline caregiving self-efficacy at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the Revised Scale for Caregiving Self-efficacy.
This scale comprises 15 items on three subscales: obtaining respite, responding to disruptive behaviors, and controlling upsetting thoughts.
Scale scores range from 0 to 100 for each subscale, where higher scores indicate better outcome.
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Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Change from baseline experiential avoidance in caregiving at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Measured by the Experiential Avoidance in Caregiving Questionnaire.
This scale comprises 15 items on three subscales: active avoidant behaviors, intolerance of negative thoughts and emotions, and apprehension concerning negative internal experiences related to caregiving.
Scale scores range from 6 to 30 for active avoidant behaviors, 4 to 16 for intolerance of negative thoughts and emotions, and 5 to 25 for apprehension concerning negative internal experiences related to caregiving.
Higher scores indicate worse outcome.
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Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Change from baseline commitment to values at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Measured by the Values Questionnaire.
This scale comprises 10 items on two subscales: obstruction and progress.
Scale scores range from 0 to 30 for each subscale.
Higher scores for the obstruction indicate lower commitment (i.e., worse outcome), and higher scores for the progress indicate higher commitment (i.e., better outcome).
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Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the Neuropsychiatric Inventory Questionnaire.
This scale comprises 12 items measuring various BPSD.
Participants (i.e., family caregivers) rated state of their care recipient.
Scale scores range from 0 to 60, where higher scores indicate worse outcome.
|
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline caregiving demands at 4 and 10 months
Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
|
Measured by the Caregiver Burden Scale.
This scale comprises 26 items on seven subscales measuring support for care recipient's activities of daily living, burden of behavioral and psychological symptoms, concern about future caregiving burden, lack of informal support, lack of formal support, caregiving interference with other roles, and financial burden of caregiving.
Higher scores indicate worse outcome.
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Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
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Usability of the intervention
Time Frame: Immediately after the intervention
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Measured by 10 items.
Scale scores range from 10 to 50, where higher scores indicate higher levels of perceived usability of the intervention (i.e., better outcome).
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Immediately after the intervention
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Change from baseline care recipient's cognitive function at 3 and 6 months
Time Frame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
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Measured by the Montreal Cognitive Assessment.
This instrument is a cognitive screening test for the detection of mild cognitive impairment and Alzheimer's disease.
Scale scores range from 0 to 30, where higher scores indicate better outcome.
This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
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Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
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Change from baseline care recipient's depression at 3 and 6 months
Time Frame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
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Measured by the Japanese version of the Geriatric Depression Scale Short Version.
This scale comprises 15 items, ranging from 0 to 15.
Higher scores indicate worse outcome.
This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
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Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
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Change from baseline care recipient's psychological distress at 3 and 6 months
Time Frame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
|
Measured by the Stress Response Scale.
This scale comprises 18 items on three subscales: depression/anxiety, irritability/anger, and helplessness.
Scale scores range from 0 to 18 for each subscale.
Higher scores indicate worse outcome.
This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
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Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
|
Baseline care recipient's cognitive function
Time Frame: Baseline
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Measured by the Mini-Mental State Examination.
This instrument is a cognitive screening test for the detection of dementia.
Scale scores range from 0 to 30, where higher scores indicate better outcome.
This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of a face-to-face setting.
|
Baseline
|
Baseline care recipient's cognitive function
Time Frame: Baseline
|
Measured by the Hasegawa Dementia Scale-Revised.
This instrument is a cognitive screening test for the detection of dementia.
Scale scores range from 0 to 30, where higher scores indicate better outcome.
This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of an online setting.
|
Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
May 13, 2021
First Submitted That Met QC Criteria
May 18, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MG21PS0401
- 21K03094 (Other Grant/Funding Number: Japan Society for the Promotion of Science)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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