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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898413
• Other study ID #: MG21PS0401
• Secondary ID: 21K03094
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Meiji Gakuin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Family Caregivers

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Meiji Gakuin University	Minato-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline caregiving demands at 4 and 10 months	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Other	Usability of 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).	Immediately after the intervention
Other	Change from baseline care recipient's cognitive function at 3 and 6 months	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.	Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Other	Change from baseline care recipient's depression at 3 and 6 months	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.	Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Other	Change from baseline care recipient's psychological distress at 3 and 6 months	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.	Baseline, 3 months (immediately after the intervention), 6 months (3 month follow-up)
Other	Baseline care recipient's cognitive function	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.	Baseline
Other	Baseline care recipient's cognitive function	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.	Baseline
Primary	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)
Primary	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	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary	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).	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)
Secondary	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.	Baseline (pre-intervention), 4 months (immediately after the intervention), and 10 months (6 month follow-up)