Title: Cognitive Behavioural Therapy to reduce anxiety and depression in patients with atrial fibrillation (CBT-AF)
Funder: Department of Health and Social Care

Abstract: Background: Elevated symptoms of anxiety and depression are prevalent in 25-40% of AF patients, persisting over time, resulting in poorer health-related quality of life (HRQoL) among AF patients, greater AF-symptom severity and AF recurrences. Current clinical practice, both primary and secondary care, does not routinely screen AF patients for anxiety/depression, or provide specific interventions to reduce psychological distress in this patient group. The CBT approach has become the favoured intervention for anxiety and depression and is considered an effective treatment option but to date there are no randomised trials testing CBT interventions that specifically target anxiety and depression in AF patients. Aims: To develop CBT interventions to reduce symptoms of anxiety and/or depression in AF patients, to assess the impact of these CBT interventions on patient s HRQoL, AF-symptom reporting, use of healthcare resources (in primary and secondary care) and patient s satisfaction with CBT, and to determine whether CBT is cost-effective compared to usual care for AF patients. Main research question: Does CBT, either therapist-led or home-based self-help, significantly reduce symptoms of anxiety and/or depression in AF patients compared to usual care? Plan of investigation: Design: A pragmatic, prospective randomised controlled trial (RCT). Patients from 83 general practices in the West Midlands will be individually randomised on a 1:1:1 basis to (1) therapist-led CBT, (2) home-based self-help CBT, or (3) usual care. Cluster randomisation at the GP practice level was deemed unnecessary since there will be an average of only 2 participants recruited per practice and the intervention will be conducted by one therapist at an independent location; the potential for treatment contamination is therefore very low. Patients: Patients aged &ge;18 years with newly-diagnosed AF (duration &le;12 months) identified from each practice will be screened for anxiety and/or depression using the Hospital Anxiety and Depression Scale (HADS); only those defined as cases (score &ge;8 on either HADS subscale) will be randomised into the trial. 55 patients will be randomised to each group. Interventions: (1) Individual therapist-led CBT, 8 weekly sessions lasting 60 minutes; (2) Home-based self-help CBT, facilitated by CBT manual (hard-copy or on-line version) which patients complete at home by themselves, with weekly telephone calls from an Arrhythmia Nurse with CBT training to discuss work-sheet based activities; or (3) usual care from their GP. Main outcome measures: Primary outcome measures are reduction in anxiety and depression, assessed by the HADS at three time-points: immediately post-CBT (2-months), 6- and 12-months. Secondary outcome measures are HRQoL [AFeQT [9], SF-12 [10], EQ-5D-5L [11]], functional status [AFSS [12]], patient satisfaction [questionnaire and qualitative sub-study], and healthcare resource utilisation. Potential benefits to patients and the NHS This research has the potential to develop two CBT interventions which if shown to be more effective than usual care in reducing anxiety and/or depression among AF patients will be available to help improve patient s mental health and well-being. Assuming that both CBT interventions are equally effective, the option of either therapist-led or home-based self-help CBT intervention could facilitate greater translation of the research into practice, giving patient s choice. Potential availability of two new effective CBT interventions to reduce psychological distress would provide GPs/physicians with other treatment options in an arena where psychological service provision is currently limited. Availability of self-help CBT would increase the access of CBT to the NHS and wider healthcare community as it negates the need for therapists and could utilise cardiovascular nurse specialists with relevant CBT training. Improving patients mental health and well-being would also hopefully improve HRQoL and reduce utilisation of other healthcare resources (GP visits, AF-related hospitalisations) and may prove to be a clinical and cost-effective intervention for patients with AF.

Lay abstract: All patients who have been diagnosed with an irregular heart rhythm, called atrial fibrillation (AF), within the last 12 months, from 83 general practices in the West Midlands will be invited to take part in this study. If they agree, a set of questionnaires will be sent to complete, including one on anxiety and depression. Patients who are found to be anxious and/or depressed using this questionnaire will be randomly allocated to receive either cognitive-behavioural therapy (CBT), a talking therapy led by a psychologist; self-help CBT, completed at home either on the computer or using a manual (depending on patient preference); or usual care (care decided by the patient s GP). Patients in the therapist-led CBT group will attend 8 individual sessions and complete worksheets. Patients in the self-help CBT group will complete 8 sessions at home and receive a weekly telephone call from a nurse with CBT training. All patients, including those receiving usual care will complete the same questionnaires 8 weeks after treatment starts and again 6- and 12-months later. The main aim of the study is to investigate whether or not the CBT interventions help to reduce anxiety and/or depression among patients with atrial fibrillation compared to people who receive usual care. We also want to discover if one CBT treatment is better than the other and if these treatments help to improve a patients quality of life, reduce their AF-symptoms and mean that they see their GP or attend the hospital less often than those receiving usual care. We will also ask if patients were satisfied with the interventions and interview some patients to discuss what they felt was useful or unhelpful about the treatments and their suggestions for changes. We will also record how much each of the treatment costs to see if they are cost-effective.

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