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

Primary Purpose

Dementia, Family Caregivers

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Group-based acceptance and commitment therapy (ACT)
Group-based cognitive behavioral therapy (CBT)
Sponsored by
Meiji Gakuin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Family caregivers, Acceptance and commitment therapy, Cognitive behavior therapy, Reminiscence therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Family caregivers:

  • providing care for a co-resident 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.

Sites / Locations

  • Meiji Gakuin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group-based acceptance and commitment therapy (ACT)

Group-based cognitive behavior therapy (CBT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.

Full Information

First Posted
May 13, 2021
Last Updated
July 15, 2022
Sponsor
Meiji Gakuin University
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1. Study Identification

Unique Protocol Identification Number
NCT04898413
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meiji Gakuin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Family Caregivers
Keywords
Dementia, Family caregivers, Acceptance and commitment therapy, Cognitive behavior therapy, Reminiscence therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-based acceptance and commitment therapy (ACT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group-based cognitive behavior therapy (CBT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based acceptance and commitment therapy (ACT)
Intervention Description
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
Intervention Name(s)
Group-based cognitive behavioral therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline depression and anxiety at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline quality of life (QOL) at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary Outcome Measure Information:
Title
Change from baseline subjective burden at 4 and 10 months
Description
Measured by the Zarit Burden Interview. This scale comprises 22 items, ranging from 0 to 88. Higher scores indicate worse outcome.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline positive aspects of caregiving at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline caregiving self-efficacy at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline experiential avoidance in caregiving at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline commitment to values at 4 and 10 months
Description
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).
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months
Description
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.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Other Pre-specified Outcome Measures:
Title
Change from baseline caregiving demands at 4 and 10 months
Description
Measured by the Caregiver Burden Scale. This scale comprises 26 items on seven subscales measuring support for care recipient's activities of daily living, burden of behavioral and psychological symptoms, concern about future caregiving burden, lack of informal support, lack of formal support, caregiving interference with other roles, and financial burden of caregiving. Higher scores indicate worse outcome.
Time Frame
Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Title
Usability of the intervention
Description
Measured by 10 items. Scale scores range from 10 to 50, where higher scores indicate higher levels of perceived usability of the intervention (i.e., better outcome).
Time Frame
Immediately after the intervention
Title
Change from baseline care recipient's cognitive function at 3 and 6 months
Description
Measured by the Montreal Cognitive Assessment. This instrument is a cognitive screening test for the detection of mild cognitive impairment and Alzheimer's disease. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
Time Frame
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Title
Change from baseline care recipient's depression at 3 and 6 months
Description
Measured by the Japanese version of the Geriatric Depression Scale Short Version. This scale comprises 15 items, ranging from 0 to 15. Higher scores indicate worse outcome. This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
Time Frame
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Title
Change from baseline care recipient's psychological distress at 3 and 6 months
Description
Measured by the Stress Response Scale. This scale comprises 18 items on three subscales: depression/anxiety, irritability/anger, and helplessness. Scale scores range from 0 to 18 for each subscale. Higher scores indicate worse outcome. This scale will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in both face-to-face and online settings.
Time Frame
Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Title
Baseline care recipient's cognitive function
Description
Measured by the Mini-Mental State Examination. This instrument is a cognitive screening test for the detection of dementia. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of a face-to-face setting.
Time Frame
Baseline
Title
Baseline care recipient's cognitive function
Description
Measured by the Hasegawa Dementia Scale-Revised. This instrument is a cognitive screening test for the detection of dementia. Scale scores range from 0 to 30, where higher scores indicate better outcome. This test will be used for participants in the care recipient's program (i.e., group-based reminiscence therapy) in the case of an online setting.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family caregivers: providing care for a co-resident 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.
Facility Information:
Facility Name
Meiji Gakuin University
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
108-8636
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Morimoto, Ph.D
Phone
+81-3-5421-5305
Email
hmori@psy.meijigakuin.ac.jp
First Name & Middle Initial & Last Name & Degree
Hiroshi Morimoto, Ph.D
First Name & Middle Initial & Last Name & Degree
Nobutake Nomura, Ph.D
First Name & Middle Initial & Last Name & Degree
Takashi Muto, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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