Group-based Acceptance and Commitment Therapy and Group-based Cognitive Behavior Therapy for Family Caregivers of People with Dementia in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline depression and anxiety at 4 and 10 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Group-based acceptance and commitment therapy (ACT) (Behavioral)
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.
干预措施: Group-based cognitive behavioral therapy (CBT) (Behavioral)
结局指标
主要结局
Change from baseline depression and anxiety at 4 and 10 months
时间窗: 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.
Change from baseline quality of life (QOL) at 4 and 10 months
时间窗: 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.
次要结局
- 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))
- 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 care recipients' behavioral and psychological symptoms of dementia (BPSD) 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 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))
研究者
Hiroshi Morimoto
Associate professor
Meiji Gakuin University