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临床试验/NCT02991183
NCT02991183已完成不适用

A Feasibility Study of Acceptance and Commitment Therapy (ACT) to Promote the Wellbeing of Carers of People With Dementia

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Fidelity

研究概览

简要总结

Background: Acceptance and Commitment Therapy (ACT) is a therapy that helps people to notice and accept difficult thoughts and emotions. ACT also helps people to identify what they value in life (e.g. a good relationship with their partner) and make changes to their behaviour to promote these values. Carers of people with dementia may experience reduced wellbeing associated with their role. Those whose wellbeing is greater than previously are said to be 'flourishing'.

Aim: The aim of this feasibility study is to evaluate the potential value of ACT as a group intervention for carers of people with dementia.

Methods: Participants will include adult carers of people with dementia. Study participants will be identified from two older people community mental health teams. Informed consent will be sought prior to group invitations being sent out. There will be two groups in total (12 in each group) and both groups will attend three 2.5 hour sessions of ACT. All participants will complete questionnaires at the beginning and 21 days later (asking questions about their thoughts and feelings, flourishing and about being a carer). Eight group participants will be invited to a focus group to understand what they found more helpful and less helpful.

Applications: Results from this study will potentially provide useful information to enable a further study with more participants to be conducted. The outcomes of this study will be shared with older people community mental health teams, dementia and carer specialist groups and potentially published in a relevant journal.

详细描述

Participants: two groups of participants will receive the ACT group intervention (Total n=24; n/Group = 12). One group of participants (n=8) who attend the ACT intervention will be invited to a focus group exploring intervention acceptability.

Recruitment Procedures: prior to recruitment commencing the researcher will present details of the study (recruitment procedures, eligibility criteria etc.) to the relevant Community Mental Health Teams (CMHTs) and at the Older Adult Psychology Team meeting. Carers of People with Dementia (CPwD) will be identified by National Health Service (NHS) staff working in Older People's CMHTs.

Potential participants will receive patient information sheet at routine appointments they attend with the person with dementia for whom they care. Carers will provide permission for their contact details to be passed to the research team using 'Notice of Interest' slip. The researcher will then arrange to meet with the carer to recruit them to the study. Informed consent will be sought and a member of the research team will complete a consent form with participants after they have had time to read the Participant Information Sheet. Consenting participants will be sent appointment letters with further details of the group.

Measures: participants will complete the following measures at the beginning and end of the ACT group intervention:

  1. Demographic questionnaire (including age, gender, length of time being in a caring role, fulltime or part-time carers, any other employment, number of individuals they care for, and their relationship to the individual they care for (e.g. spouse, sibling, child, other).
  2. Acceptance and Action Questionnaire: (AAQII). The AAQII is a 7 item questionnaire, which measures psychological flexibility on a 7 point Likert scale.
  3. Mental Health Continuum-Short Form (MHC-SF). The MHC-SF is a 14 item questionnaire, measuring wellbeing on a 6 point Likert scale.
  4. Experiential Avoidance in Caregiving Questionnaire (EACQ) The EACQ is a 15 item questionnaire, which measures experiential avoidance on a 5 point Likert scale.
  5. Caregiver Burden Scale (CBS).The CBS is a 21 item questionnaire, which measures the overall level of burden carers experience in relation to their spouse or relative on a 5 point Likert scale.
  6. Recruitment and retention parameters: A sample size of at least 12 people per group for pilot pharmaceutical studies will be an indicator of sufficient recruitment. However, 8 has been suggested as the optimum number of group participants in psychological interventions. Therefore, a figure of no more than 33% attrition from baseline to final assessment will be used to indicate that the ACT group intervention is feasible in terms of retention.
  7. Group Evaluation Form: A brief survey will be completed with Likert scales and free text boxes for reflections on participants experience of attending the ACT groups.
  8. Focus group: A smaller number of participants (n = 8) will also be invited to attend a focus group to explore their view of taking part in the ACT groups. This will be audio-recorded and transcribed for analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 116 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • carers of people with a diagnosis of any type of dementia
  • primary caregiver of the person with dementia for 3 months or more
  • informed consent
  • adequate English language skills

排除标准

  • receiving any type of concurrent psychotherapy
  • diagnosis of a severe or acute mental health problem (such as psychosis, anxiety, depression) when consent to participate is sought

研究组 & 干预措施

Acceptance and Commitment Therapy

Experimental

Two half day (2.5 hours) group ACT sessions delivered one week apart followed by a third session 2 weeks following the second session.

干预措施: ACT (Behavioral)

结局指标

主要结局

Fidelity

时间窗: 4 weeks

Fidelity of the intervention to the ACT approach (measure developed by research team)

Well-being

时间窗: Time 0 and week 4

Change in score from Mental Health Continuum Short Form questionnaire

Number of participants recruited and retained to study completion

时间窗: 4 weeks

Acceptability

时间窗: 4 weeks

Qualitative responses to Acceptability questionnaire devised by research team

次要结局

  • Caregiver Burden(Time 0 and week 4)
  • Psychological Flexibility in Caregivers(Time 0 and week 4)
  • Psychological Flexibility(Time 0 and week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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