Title: A randomised CONtrolled trial of Tailored Acceptance and Commitment Therapy for older people with treatment resistant Generalised Anxiety Disorder (CONTACT-GAD)
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Generalised anxiety disorder (GAD), characterised by a tendency to worry, is the most common anxiety disorder in older people. Medication and talking therapy are usually offered as forms of treatment, but many do not find them helpful. Guidance on how to help older people manage GAD when it does not respond to such treatments is lacking. In our earlier work (the FACTOID study), we developed and tailored a talking therapy intervention to the specific psychological, physical and cognitive needs of older people with treatment-resistant GAD (TR-GAD). This was based on Acceptance and Commitment Therapy (ACT); a form of talking therapy that helps people learn how best to live with distressing thoughts, feelings and sensations, while still doing things that really matter to them. ACT has been found to be helpful in other conditions including anxiety, depression and chronic pain, and may be particularly suited to older people with TR-GAD. We showed it was possible and acceptable to deliver our intervention in the NHS, and that it may help improve anxiety, depression and coping in this population._x000D_ _x000D_ AIMS: We would now like to find out whether tailored ACT is helpful for older people with TR-GAD and whether it represents value for money in a larger clinical trial._x000D_ _x000D_ PLAN: We will recruit 296 people aged 60+ years with TR-GAD that has failed to respond to previous drug and/or talking treatments or those with TR-GAD who have been unable to tolerate such treatments. We will recruit from GPs and psychological therapies services in primary and secondary care and the community across 15 sites in the UK and Australia. We will recruit participants from a broad range of diverse groups and under-represented populations so that we can ensure our findings are applicable to a broader population. Participants will be allocated at random to have tailored ACT plus usual care or usual care alone within a clinical trial. Participants will receive up to 14 sessions of therapy plus 1 booster session, 3 months after therapy. These will be delivered in person (either in the home or clinic) or via video/phone call, depending on participant preference, therapist availability and the pandemic. All therapists will receive training and supervision in tailored ACT. We will test whether tailored ACT plus usual care leads to a greater reduction in anxiety than usual care alone at 6 months. We will follow people up at 12 months to see if any gains are maintained. We will also look at ACT's value for money compared to usual care, as well as quality of life, depression, adverse effects, satisfaction, adherence and behaviour change. We will invite participants and therapists to complete a questionnaire at the end of therapy to examine how acceptable it was and things that helped or hindered participation._x000D_ _x000D_ PUBLIC INVOLVEMENT: Our study design has been informed by discussions with our Public Involvement Group. For example, they advised that change in anxiety should be our primary outcome. Our study design has also been informed by discussions with clinical services in primary and secondary care. We will continue to involve our Public Involvement Group in the refinement of our intervention, research management, study material and dissemination._x000D_ _x000D_ IMPLICATIONS: We hope our results will provide timely and much needed guidance to the NHS regarding the management of TR-GAD in older people and will allow us to plan and deliver more effective clinical services for them.

Lay abstract: BACKGROUND: Generalised anxiety disorder (GAD), characterised by excessive anxiety and worry, is the most common anxiety disorder in older people. It may persist for decades and is associated with multiple negative outcomes in older people, including poorer quality of life, increased disability and greater healthcare use. First-line treatments include pharmacotherapy (e.g. selective serotonin reuptake inhibitors) and psychological therapies (e.g. cognitive behavioural therapy and applied relaxation). However, many older people with GAD find these treatments ineffective or difficult to tolerate, leaving clinicians unsure how to best manage the condition. At present, there is little evidence to guide management._x000D_ _x000D_ Acceptance and Commitment Therapy (ACT) is a psychological therapy that helps people learn how best to live with distressing thoughts, feelings and bodily sensations, while continuing to do the things that really matter to them. To our knowledge, our feasibility study of tailored ACT for older people with treatment-resistant GAD (TR-GAD; FACTOID) is the only study to have developed a psychological intervention for the specific psychological, physical and cognitive needs of this population. We showed it was feasible and acceptable to deliver tailored ACT in the NHS, and that it may help reduce anxiety and depression symptoms in older people with TR-GAD._x000D_ _x000D_ AIMS: To test the clinical and cost effectiveness of tailored ACT plus usual care for reducing anxiety in comparison to usual care alone in older people with TR-GAD._x000D_ _x000D_ DESIGN: A multicentre, single-blind, parallel RCT, with a 9-month internal pilot and clear stop/go criteria for progression to the full RCT._x000D_ _x000D_ SETTINGS: Primary and secondary care settings and the community in the UK and Australia._x000D_ _x000D_ PARTICIPANTS: 296 people aged 60+ years with TR-GAD that has failed to respond adequately to previous pharmacotherapy and/or psychological therapy within steps 1-3 of the stepped care approach for GAD or those with TR-GAD who have been unable to tolerate such treatment: 218 participants will be recruited in the UK (from at least 11 sites) and 78 will be recruited in Australia (from 4 sites). Participants will be recruited from diverse groups and under-represented populations (with respect to race, ethnicity, gender, socio-economic status, etc)._x000D_ _x000D_ RANDOMISATION: Participants will be randomly allocated in a 1:1 ratio to tailored ACT plus usual care or usual care alone via the CTRU’s online system._x000D_ _x000D_ INTERVENTION: Participants will receive up to 14 sessions of tailored ACT plus usual care with 1 booster session, delivered in person (in the home or clinic) or via video call, depending on participant preference, therapist availability and COVID-19 pandemic restrictions. Therapists will receive training and supervision in intervention delivery._x000D_ _x000D_ COMPARATOR: Usual care._x000D_ _x000D_ PRIMARY OUTCOME: Change in anxiety on the Generalised Anxiety Disorder Assessment (GAD-7), as our Public Involvement group considered anxiety to be the most important outcome. _x000D_ _x000D_ SECONDARY OUTCOMES: Quality of life, depression, psychological flexibility, health and social care resource use, cost-effectiveness, adverse events, satisfaction with services, adherence and personally meaningful behaviour change. Qualitative questionnaires will examine barriers to implementation in participants/therapists._x000D_ _x000D_ TIMING OF OUTCOMES: 0, 6 and 12-months post-randomisation by a blind outcome assessor: the primary endpoint will be at 6 months post-randomisation, with final assessment at 12 months to examine whether potential gains are maintained beyond 6 months._x000D_ _x000D_ SAMPLE SIZE: 296 participants will allow detection of an effect size of 0.37 SDs with a 2-sided alpha of 5% and 90% power, assuming 20% attrition at 6 months, a 0.05 ICC among therapists and a 0.55 correlation between outcomes at 0 and 6 months._x000D_ _x000D_ DATA ANALYSIS: Quantitative, qualitative and health economic data analyses will be conducted._x000D_ _x000D_ PATIENT & PUBLIC INVOLVEMENT: Our study design is informed by interviews with older people with TR-GAD and therapists from our feasibility study, and discussions with our Public Involvement Group. We will continue to involve our Public Involvement Group in trial management, design of study materials, interpretation of qualitative data and dissemination of the findings._x000D_ _x000D_ TIMETABLE: -6-0 months: Identify therapists, develop documentation. 1-9 months: Orientation, obtain HRA approval, RCT set-up, train therapists. 10-18 months: Internal pilot. 19-36 months: Recruitment to full RCT. 10-48 months: Collect outcomes. 49-54 months: Database lock, analyses, dissemination._x000D_ _x000D_ TEAM: Our team has substantial expertise in conducting RCTs of psychotherapeutic interventions in older people and are well placed to achieve the successful completion of the proposed trial._x000D_ _x000D_ DISSEMINATION: Results will be disseminated through international open-access academic journals, blogs, conferences, talks, social media and training seminars._x000D_ _x000D_ IMPACT: This trial will evaluate a new psychological approach to the management of TR-GAD in older people. If clinical and/or cost effectiveness of this approach is demonstrated, then we will have sufficient evidence to provide timely and much needed guidance to the NHS and other international bodies. This will allow us to plan and deliver more effective clinical services for this population.

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