Clinical trial NCT04898413: Group-based Acceptance and Commitment Therapy for Family Caregivers of People With Dementia in Japan
Official title: Group-based Acceptance and Commitment Therapy and Group-based Cognitive Behavior Therapy for Family Caregivers of People With Dementia in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Family Caregivers
Keywords: Dementia
Family caregivers
Acceptance and commitment therapy
Cognitive behavior therapy
Reminiscence therapy
Lead sponsor: Meiji Gakuin University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline depression and anxiety at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline quality of life (QOL) at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary outcomes:
measure: Change from baseline subjective burden at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline positive aspects of caregiving at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline caregiving self-efficacy at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline experiential avoidance in caregiving at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline commitment to values at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Other outcomes:
measure: Change from baseline caregiving demands at 4 and 10 months
timeFrame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
measure: Usability of the intervention
timeFrame: Immediately after the intervention
measure: Change from baseline care recipient's cognitive function at 3 and 6 months
timeFrame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
measure: Change from baseline care recipient's depression at 3 and 6 months
timeFrame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
measure: Change from baseline care recipient's psychological distress at 3 and 6 months
timeFrame: Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
measure: Baseline care recipient's cognitive function
timeFrame: Baseline
measure: Baseline care recipient's cognitive function
timeFrame: Baseline
Locations:
city: Minato-Ku
country: Japan
facility: Meiji Gakuin University
state: Tokyo
Study officials:
References: