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

NCT04898413 | Completed

• 2 other identifiers: MG21PS040121K03094
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia; Family Caregivers

Keywords

Dementia; Family caregivers; Acceptance and commitment therapy; Cognitive behavior therapy; Reminiscence therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)

Other Outcomes (7)

• Change from baseline caregiving demands at 4 and 10 months

  Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)

• Usability of the intervention

  Immediately after the intervention

• Change from baseline care recipient's cognitive function at 3 and 6 months

  Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)

Study Arms (2)

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.

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.

Behavioral: Group-based cognitive behavioral therapy (CBT)

Interventions

Group-based acceptance and commitment therapy (ACT) 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 acceptance and commitment therapy (ACT)

Group-based cognitive behavioral therapy (CBT) 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.

Group-based cognitive behavior therapy (CBT)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meiji Gakuin University: lead

Study Sites (1)

Meiji Gakuin University

Minato-Ku, Tokyo, 108-8636, Japan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 24, 2021
• Study Start: June 1, 2021
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)