Group-based Acceptance and Commitment Therapy for Family Caregivers of People with Dementia in Japan

Not Applicable

Completed

• Conditions: Dementia; Family Caregivers
• Interventions: Behavioral: Group-based acceptance and commitment therapy (ACT); Behavioral: Group-based cognitive behavioral therapy (CBT)

• Registration Number: NCT04898413
• Lead Sponsor: Meiji Gakuin University

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.

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Study Start: 2021-06-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-based acceptance and commitment therapy (ACT)	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)	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline depression and anxiety at 4 and 10 months	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	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline experiential avoidance in caregiving at 4 and 10 months	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)	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.
Change from baseline commitment to values at 4 and 10 months	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)	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).
Change from baseline subjective burden at 4 and 10 months	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.
Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months	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.
Change from baseline caregiving self-efficacy at 4 and 10 months	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.
Change from baseline positive aspects of caregiving at 4 and 10 months	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)	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.

Trial Locations

Locations (1)

Meiji Gakuin University; 🇯🇵 Minato-Ku, Tokyo, Japan