A randomised CONtrolled trial of Tailored Acceptance and Commitment Therapy for older people with treatment resistant Generalised Anxiety Disorder (CONTACT-GAD)

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. 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. 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. DESIGN: A multicentre, single-blind, parallel RCT, with a 9-month internal pilot and clear stop/go criteria for progression to the full RCT. SETTINGS: Primary and secondary care settings and the community in the UK and Australia. 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). 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. 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. COMPARATOR: Usual care. 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. 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. 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. 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. DATA ANALYSIS: Quantitative, qualitative and health economic data analyses will be conducted. 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. 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. 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. DISSEMINATION: Results will be disseminated through international open-access academic journals, blogs, conferences, talks, social media and training seminars. 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.