Title: The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): A randomised controlled trial with ethnically diverse family carers
Funder: Department of Health and Social Care

Abstract: Aim of the research This large trial has two main aims, to find out: 1) if internet-delivered self-help Acceptance and Commitment Therapy (online ACT) for family carers of people with dementia is helpful in reducing anxiety and affordable; 2) how online ACT can be successfully delivered to diverse carer populations and in different healthcare settings. Background to the research Family carers are at higher risk of anxiety and depression. Offering treatments online improves availability for people who have mobility problems, live remotely or cannot leave home. This makes it more accessible to everyone and easier to provide, so could be rolled out nationally, reducing inequalities in access to care. We conducted a first study to explore if we could deliver ACT for family carers of people with dementia online within GPs and NHS mental health services, and family carer views of it (acceptability). This was successful and more than 100 potential participants were referred to the study in just six months. Thirty-three eligible participants received online ACT, more than originally planned. We now need a larger trial involving enough carers to establish whether online ACT can reduce carer anxiety and is affordable, and whether it should be widely rolled out in the NHS. Design and methods used Phase 1: Using feedback from the first study we will refine online ACT with Patient and Public Involvement input so that it is more acceptable to carers from ethnic minority groups. We will test the refined programme with a small group of carers from ethnic minority groups and make further improvements if needed. Phase 2: We will recruit 496 family carers with anxiety, as that is the number we need to be sure that online ACT is adequately tested. Recruitment will target community groups, and GPs and NHS mental health services with a specific focus on underrepresented people from ethnic minority groups. This is a randomised trial, where a computer allocates half the people to intervention and half to control group (standard care). People in the online ACT group will be asked to complete the intervention at their own pace with feedback from the therapist to support them for each completed session. Participants in both groups will be asked to complete questionnaires assessing anxiety and depression before and after the intervention and three months after that. We will also interview participants, therapists and clinicians involved in recruitment to gain in-depth insights into their views on the intervention and its implementation. Patient and public involvement (PPI) PPI members are part of our research team, involved in every part of the project. PPI members from ethnic minority groups suggested including one-to-one interactions with the therapist via telephone or video call would make the intervention more acceptable and accessible. We will try this during Phase 1. We will also take up PPI members suggestions of broader recruitment strategies such as involving places of worship to maximise recruitment of participants from ethnic minority groups. Dissemination We will hold a national event with our PPI members for health and social care services professionals, people with dementia and their carers, to share our findings. If online ACT is effective, we will organise a workshop where key stakeholders will co-produce a roll out manual outlining for wide NHS use.

Lay abstract: Research question What is the clinical and cost effectiveness of iACT4CARERS plus treatment-as-usual (TAU) in comparison to TAU alone for reducing anxiety in family carers of people with dementia? Background Despite the high prevalence of anxiety and depression, many family carers of people with dementia are not able to access timely psychological support due to various barriers. To address this challenge of accessibility, we received funding from the NIHR to develop internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS) and test its feasibility and acceptability. This feasibility study was successful, meeting all pre-defined criteria for progression from the feasibility study to a full-scale trial. Therefore, randomised controlled trial (RCT) evidence on clinical- and cost-effectiveness of this new intervention is now required. Aims and objectives 1. To finalise iACT4CARERS based on recommendations from our feasibility study and Patient and Public Involvement (PPI) work. 2. To establish the clinical and cost effectiveness of iACT4CARERS plus TAU compared to TAU alone in an RCT with an internal pilot phase. 3. To assess fidelity and quality of implementation, establish causal mechanisms and identify contextual factors associated with variation in outcomes using the process evaluation approach. Methods Phase 1: Following feedback from the pilot and PPI input, the manual for the additional element of the programme (brief one-to-one sessions via telephone/video call outside the online sessions) will be co-produced so that iACT4CARERS is more acceptable to a diverse population. The refined programme will be piloted with 10 carers from ethnic minority groups to gain preliminary feedback and agree on final refinements. Phase 2: A multi-site, parallel, 2-arm RCT with a 10-month internal pilot will be conducted to assess the clinical and cost effectiveness. 496 family carers including carers from ethnic minority groups will be recruited from community groups, GPs and NHS mental health services. Participants will be randomised to iACT4CARERS plus TAU or TAU alone. Participants in both arms will be asked to complete outcome measures at baseline (0 months) and 3 and 6 months post-randomisation. The primary outcome and timepoint will be anxiety at 3 months. Individual interviews will also be conducted with carers, therapists and referrers to understand factors that may influence implementation and/or outcomes. Timelines for delivery Months 1-18: Pilot and finalise the refined intervention (Phase 1); identify and train non-expert therapists (Phase 2); Set up study sites and advertise the study (Phase 2). Months 19-44: Recruit participants; collect data including follow up assessments (Phase 2). Months 45-48: Write up the results; organise and deliver dissemination events (Phase 2). Anticipated impact and dissemination An end of study dissemination event will be organised. If the intervention is effective, we will organise a workshop where key stakeholders will be invited to co-produce the procedural manual for implementation. The successful completion of a full-scale RCT could result in immediate impacts which include: 1) the provision of a new evidence-based online intervention for carers; and 2) the expansion of the knowledge base about how this intervention can be implemented within healthcare services, and what factors hamper the implementation and achievement of outcomes.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH