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

NCT ID: NCT04898413

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-03-15

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.

Conditions

Dementia; Family Caregivers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 Type: EXPERIMENTAL

Group-based acceptance and commitment therapy (ACT)

Intervention Type: BEHAVIORAL

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 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 Type: ACTIVE_COMPARATOR

Group-based cognitive behavioral therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meiji Gakuin University

OTHER

Sponsor Role: lead

Responsible Party

Hiroshi Morimoto

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meiji Gakuin University

Minato-Ku, Tokyo, Japan

Countries

Japan

Other Identifiers

21K03094

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MG21PS0401

Identifier Type: -

Identifier Source: org_study_id