DementiaNCT04898413
Group-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia in Japan
A study testing Group-based acceptance and commitment therapy (ACT) and Group-based cognitive behavioral therapy (CBT) in people with Dementia and Family Caregivers, run by Meiji Gakuin University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Family Caregivers
- What is being tested?
- Group-based acceptance and commitment therapy (ACT) and Group-based cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2021to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Dementia, Family Caregivers
- Being tested
- Group-based acceptance and commitment therapy (ACT), Group-based cognitive behavioral therapy (CBT)
- Keywords
- Dementia, Family caregivers, Acceptance and commitment therapy, Cognitive behavior therapy, Reminiscence therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based acceptance and commitment therapy (ACT)Behavioural
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.
Group-based cognitive behavioral therapy (CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group-based acceptance and commitment therapy (ACT) | Experimental | 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. Receives: Behavioral: Group-based acceptance and commitment therapy (ACT) |
| Group-based cognitive behavior therapy (CBT) | Active comparator | 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. Receives: Behavioral: Group-based cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline depression and anxiety at 4 and 10 months
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.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Change from baseline quality of life (QOL) at 4 and 10 months
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.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary outcomes (6)
Change from baseline subjective burden at 4 and 10 months
Measured by the Zarit Burden Interview. This scale comprises 22 items, ranging from 0 to 88. Higher scores indicate worse outcome.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Change from baseline positive aspects of caregiving at 4 and 10 months
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.
Measured: 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
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.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Change from baseline experiential avoidance in caregiving at 4 and 10 months
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.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Change from baseline commitment to values at 4 and 10 months
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).
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months
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.
Measured: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2021
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Gakuin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroshi Morimoto, Meiji Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898413
- Sponsor's protocol ID
- MG21PS0401
- Other IDs
- 21K03094
- Status last verified
- Mar 2025
- First submitted
- 13 May 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Acceptance and Commitment Therapy and Group-based Cognitive Behavior Therapy for Family Caregivers of People With Dementia in Japan
- ClinicalTrials.gov ID
- NCT04898413
- Acronym / sponsor ID
- MG21PS0401
- Conditions
- Dementia, Family Caregivers
- Keywords
- Dementia, Family caregivers, Acceptance and commitment therapy, Cognitive behavior therapy, Reminiscence therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Meiji Gakuin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based acceptance and commitment therapy (ACT) | Experimental | Behavioral: 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 cognitive behavior therapy (CBT) | Active comparator | Behavioral: Group-based cognitive behavioral 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- having a clear intention to participate in the intervention
- being able to speak Japanese
Key exclusion criteria (5 listed)
- having psychiatric disorder at the time of participation in the intervention.
- having insufficient capacity to give consent to participate in the intervention
- being diagnosed with moderate to severe stage of dementia or MoCA scores < 11.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based acceptance and commitment therapy (ACT)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. | Behavioural | Group-based acceptance and commitment therapy (ACT) |
| Group-based cognitive behavioral therapy (CBT)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. | Behavioural | Group-based cognitive behavior therapy (CBT) |
Primary outcome
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.
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.
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based acceptance and commitment therapy (ACT) and Group-based cognitive behavioral therapy (CBT) in people with Dementia and Family Caregivers, run by Meiji Gakuin University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.