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

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ClinicalTrials.gov Identifier: NCT04898413
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Hiroshi Morimoto, 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).

Condition or disease Intervention/treatment Phase
Dementia Family Caregivers Behavioral: Group-based acceptance and commitment therapy (ACT) Behavioral: Group-based cognitive behavioral therapy (CBT) Not Applicable

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 a month, each lasting about 60-90 minutes, over the course of about nine months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Group-based Acceptance and Commitment Therapy and Group-based Cognitive Behavior Therapy for Family Caregivers of People With Dementia in Japan
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: 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 a month, each lasting about 60-90 minutes, over the course of about nine months.
Behavioral: 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.

Active Comparator: 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 a month, each lasting about 60-90 minutes, over the course of about nine months.
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.




Primary Outcome Measures :
  1. Change from baseline depression and anxiety at 4 and 10 months [ Time Frame: 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.

  2. Change from baseline quality of life (QOL) at 4 and 10 months [ Time Frame: 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 :
  1. Change from baseline subjective burden at 4 and 10 months [ Time Frame: 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.

  2. Change from baseline positive aspects of caregiving at 4 and 10 months [ Time Frame: 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.

  3. Change from baseline caregiving self-efficacy at 4 and 10 months [ Time Frame: 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.

  4. Change from baseline experiential avoidance in caregiving at 4 and 10 months [ Time Frame: 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.

  5. Change from baseline commitment to values at 4 and 10 months [ Time Frame: 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).

  6. Change from baseline care recipients' behavioral and psychological symptoms of dementia (BPSD) at 4 and 10 months [ Time Frame: 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.


Other Outcome Measures:
  1. Change from baseline caregiving demands at 4 and 10 months [ Time Frame: Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up) ]
    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.

  2. Usability of the intervention [ Time Frame: Immediately after the intervention ]
    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).

  3. Change from baseline care recipient's cognitive function at 3, 6, 9 months [ Time Frame: Baseline, 3 months (during the intervention), 6 months (during the intervention), 9 months (immediately after the intervention) ]
    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).

  4. Change from baseline care recipient's depression at 3, 6, 9 months [ Time Frame: Baseline, 3 months (during the intervention), 6 months (during the intervention), 9 months (immediately after the intervention) ]
    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).

  5. Change from baseline care recipient's psychological distress at 3, 6, 9 months [ Time Frame: Baseline, 3 months (during the intervention), 6 months (during the intervention), 9 months (immediately after the intervention) ]
    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).

  6. Baseline care recipient's cognitive function [ Time Frame: Baseline ]
    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).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Family caregivers:

  • providing care for a co-resident family member with dementia
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898413


Locations
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Japan
Meiji Gakuin University Recruiting
Minato-Ku, Tokyo, Japan, 108-8636
Contact: Hiroshi Morimoto, Ph.D    +81-3-5421-5305    hmori@psy.meijigakuin.ac.jp   
Principal Investigator: Hiroshi Morimoto, Ph.D         
Sub-Investigator: Nobutake Nomura, Ph.D         
Sub-Investigator: Takashi Muto, Ph.D         
Sponsors and Collaborators
Meiji Gakuin University
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Responsible Party: Hiroshi Morimoto, Associate professor, Meiji Gakuin University
ClinicalTrials.gov Identifier: NCT04898413    
Other Study ID Numbers: MG21PS0401
21K03094 ( Other Grant/Funding Number: Japan Society for the Promotion of Science )
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hiroshi Morimoto, Meiji Gakuin University:
Dementia
Family caregivers
Acceptance and commitment therapy
Cognitive behavior therapy
Reminiscence therapy
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders