Title: Addressing a Critical Need: Feasibility of Acceptance and Commitment Therapy for Bariatric Surgery Patients at 15-18 months post surgery
Funder: Department of Health and Social Care

Abstract: There is a critical unmet need for psychological support after bariatric surgery, especially in the longer term, which has cost implications. Bariatric surgery is an effective treatment for obesity and its comorbidities in long-term follow-up. However, approximately 20% of patients will regain lost weight leading to the return of both physical comorbidities associated with obesity, and psychological difficulties such as depression, or the emergence of alternative addictive behaviour such as alcohol dependency. Many of these difficulties arise and increase from 1 year post-surgery and, paradoxically, when they are being discharged from follow-up by bariatric services (2 years post-surgery). This is therefore a time of critical need for psychological support. Acceptance and Commitment therapy (ACT) is a third wave cognitive behavioural therapy which incorporates teaching mindfulness of unconscious motivators of behaviour and acquiring the skills to accept distress, whilst mindfully holding meaningful goals in-line with personal values as motivators for sustained lifestyle change. The interaction of bariatric surgery on food reward pathways is established. The goals and mechanism of action of ACT may help bariatric patients cope with the specific reward deficit brought about by losing the emotional reward from food and may prevent the costly problem of weight regain. The benefits of ACT in weight-management have been established, but only one small controlled trial has used ACT for post-bariatric surgery patients with suggested improvements in disordered eating, body dissatisfaction and quality of life. Process analyses identified enhanced psychological flexibility and reduced reward-driven eating as mediating factors. The participants of that study were at a wide range of months post-surgery (4-38); benefits may be increased if ACT is focused at a recognised time of critical need. Aim: To assess the feasibility of a definitive trial examining whether ACT reduces weight regain and promotes psychological health when delivered at recognised time of critical need after bariatric surgery. The study will provide information regarding recruitment and characteristics of proposed outcome measures to inform a definitive trial. To achieve this we will: examine weight regain in bariatric surgery patients before and after usual treatment or an ACT group intervention; examine impact on other outcomes of interest including psychological and physical health and healthy lifestyle behaviours; monitor recruitment and attrition; explore participant and staff views about acceptability; gather preliminary information to inform economic evaluation; gather process data to inform potential mechanisms by which ACT may be effective in this population. Plan of investigation: This feasibility study will compare in a randomized controlled trial, 29 patients who receive 10 group sessions of manualized ACT with 29 patients who receive 10 sessions of treatment as usual (unstructured support group) over the same length of time (3 months), delivered by the same therapist. Recruitment rate and attrition will be recorded. Weight and physical and psychological co-morbidity, alcohol use, quality of life, physical activity, and health service usage will be measured. Process variables relating to the ACT model will be measured and qualitative interviews, in a subsample, will provide further information on acceptability of the intervention and trial procedures. Potential benefit to patients and the NHS: Weight regain and psychological complications after bariatric surgery carry cost implications for the NHS and can be personally devastating for patients. Our study will inform the development of an RCT to add to the limited current evidence to develop appropriate psychological regimens for post-operative patients. In this way, we hope to reduce the problem of weight regain, the need for revision surgeries, and dangerous psychological sequelae such as depression or alcohol or drug misuse so that more patients will optimally benefit from bariatric surgery long-term in quality of life and improved health.

Lay abstract: We will test whether people who have had bariatric surgery at least one year ago find 10 weeks of Acceptance and Commitment Therapy (ACT) an acceptable treatment and whether it would be feasible to conduct, in future, a trial to test whether ACT works. This project will tell us whether the methods, such as how people are recruited, asked for consent, allocated to the ACT group and how data is collected, are likely to work on a bigger scale. Trials big enough to inform us whether treatments work are costly, so this small study is needed to work out the best methods for the future. We will also interview some of those who have taken part to understand their views more fully. Being very overweight causes many problems. Bariatric surgery is the most effective long term solution for very overweight people. However it is expensive and can be unpleasant, so it is a shame that about one in five people who have this surgery end up putting weight back on. The British Obesity Surgery Patient Association (BOSPA) runs support groups for these patients. We have worked with a BOSPA carer/facilitator and bariatric patients to develop this work. Depression, addiction problems and weight regain commonly develop later on after surgery. Not being able to enjoy food, losing the comfort from food, finding it hard to resist food and focussing too much on feeling hungry make this more likely. ACT is a type of psychological therapy which tackles these processes and has worked in other conditions. For instance, ACT teaches awareness of thoughts and feelings which influence behavior, compassion and mindful holding of meaningful goals in line with the person s values.This project is the first step in testing whether ACT can help people who have had bariatric surgery.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CARDIOVASCULAR;CANCER AND NEOPLASMS;STROKE;ORAL AND GASTROINTESTINAL;METABOLIC AND ENDOCRINE