Title: A feasibility study of Acceptance and Commitment Therapy for older people with treatment-resistant generalised anxiety disorder (FACTOID)
Funder: Department of Health and Social Care

Abstract: PHASE 1: Conduct qualitative interviews in London and Oxfordshire to explore previous experiences of psychotherapy and the acceptability of Acceptance and Commitment Therapy (ACT) to older people with generalised anxiety disorder (GAD). Use these data and discussions with experts in the field to develop an ACT manual, tailored to the needs of older people using age-appropriate cognitive behavioural therapy and gerontological theory principles. Conduct further qualitative interviews to explore the acceptability of our manual and ways of optimising engagement. Make modifications to our manual in partnership with our Service User Advisory Group. Conduct a nationwide survey of service users' and clinicians' views of usual care for treatment-resistant GAD in older people. PHASE 2: DESIGN: Open uncontrolled feasibility study. PARTICIPANTS: 40 older people aged 65+ with treatment-resistant GAD will be recruited via community self-referral, GPs (direct and via list searches), Improving Access to Psychological Therapies services, and Community Mental Health Teams for older people in London. INCLUSIONS: Will include aged 65+, primary diagnosis of treatment-resistant GAD, living in the community, and able to provide informed consent. EXCLUSIONS: Will include diagnosis of dementia or evidence of an undiagnosed condition (other psychiatric comorbidities will not be excluded), and currently receiving psychotherapy. INTERVENTION: An anticipated 16 sessions over 18 weeks of individual ACT based on the acceptance model of GAD, delivered within GP surgeries, outpatient clinics or service users' homes by therapists in Psychological Therapies services in primary and secondary care. Therapists will receive training and regular supervision. All sessions will be recorded and a random selection assessed for treatment fidelity. Usual care will be delineated using the Client Service Receipt Inventory. CO-PRIMARY OUTCOMES: Acceptability (60%+ attendance, number of ‘satisfactory’ ratings of therapy) and feasibility (80%+ of target recruitment within 10 months, 60%+ retention rate). SECONDARY OUTCOMES: Other measures of acceptability and feasibility, including qualitative interviews with therapists and service users, and clinical and cost-effectiveness patient-reported outcomes. TIMING OF OUTCOMES: 18 weeks or 10 months for acceptability/feasibility; 0 and 18 weeks for patient-reported outcomes. PHASE 3: Analyse data, refine manual, and disseminate results. Key projected outputs will include a patient-centred manualised intervention following MRC (2008) guidelines, estimates of the acceptability and feasibility of our intervention, and clarification of usual care and other key study design parameters. OUR TEAM: Has expertise in: developing psychotherapy manuals for older people (GL, MS, PW, RG); ACT and mindfulness-based approaches (MS, RG); primary care (KW); qualitative research (VL); statistics (RJ); and trial methodology (GL, KW, MS, PW, RG, RH). Our team has experience of working together (all members), and of leading NIHR-funded studies (GL, KW, MS, RH). Our collaborators have research/clinical/personal expertise or experience in GAD in older people. TIMETABLE: -6-0 mths: Obtain ethical approval. 1-3 mths: Orientation; conduct survey; develop manual. 4-9 mths: Conduct interviews; develop manual. 7-20 mths: Train therapists; recruit; deliver ACT; collect data. 19-24 mths: Analyse data; revise manual; disseminate results.

Lay abstract: BACKGROUND: Generalised anxiety disorder (GAD), characterised by a tendency to worry, is the most common anxiety disorder in older people. It is associated with distress, difficulty in coping, poor quality of life and increased disability. Medication and talking therapy are usually offered to older people experiencing GAD, but many do not respond. Guidance as to how best manage treatment-resistant GAD in older people is lacking. AIMS: We will assess how acceptable and feasible it is to develop and deliver a new form of evidence-based talking therapy called Acceptance and Commitment Therapy (ACT). ACT helps people to learn different ways of coping with distressing thoughts and feelings, and how to take part in more activities that are meaningful to them. It is helpful for reducing distress in other conditions including anxiety, depression, life-limiting illness and chronic pain. It may be particularly suited to older people with treatment-resistant GAD as many experience difficulties with chronic ill health and other problems. Conventional talking therapy tries to help improve these difficulties, but this is not always possible. ACT, with its focus on helping people learn how to best live with such difficulties, may be more helpful. METHODS: In Phase 1 we will develop an ACT manual in partnership with service users (via qualitative interviews and our advisory group), tailored to the specific needs of older people. A nationwide survey with service users and clinicians will identify what care older people with treatment-resistant GAD usually receive. In Phase 2 we will test how acceptable and feasible our manual is with 40 older people with treatment-resistant GAD (those who have not responded to medication and/or conventional talking therapy). Participants will be identified from self-referrals, GPs, talking therapy services, and specialist mental health services. Those who are eligible will receive face-to-face ACT in their own home, clinic or GP surgery depending on physical mobility and level of anxiety. Therapists from talking therapy and specialist mental health services will receive training in ACT and regular supervision. We will assess progress by asking participants at 0 and 18 weeks to complete questionnaires in a range of areas including anxiety, worry, depression, quality of life, and satisfaction with therapy. Therapists and participants will also be invited to complete interviews afterwards to further assess how acceptable and feasible our manualised therapy is. Our evaluation of whether ACT is acceptable to older people with treatment-resistant GAD and feasible to deliver in the NHS will be determined by the number of sessions that people attend, satisfaction ratings, and recruitment/retention rates. In Phase 3 we will refine our manual, analyse data and disseminate results. PATIENT & PUBLIC INVOLVEMENT: The design of our study, PPI input and lay communication have been informed by discussions with service users and clinicians. We will involve service users in manual development, research management, data analysis, training of therapists, and dissemination. DISSEMINATION: We will disseminate our findings through journal articles, press releases, conference presentations, and talks. IMPLICATIONS: Our results will provide timely and much needed guidance to the NHS regarding the management of treatment-resistant GAD in older people, and will allow us to plan and deliver more effective clinical services for them.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH