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The ExACT Trial – The effectiveness of Exercise combined with Acceptance and Commitment Therapy compared to a standalone supervised exercise intervention for chronic pain – A randomised controlled trial

The aim of this RCT is to compare the effectiveness of supervised exercise combined with Acceptance and Commitment Therapy (ACT) with a standalone supervised exercise intervention for chronic pain. Exercise is well established as an effective treatment for chronic pain and there is emerging evidence to suggest that ACT is an effective psychological approach. This will be the first RCT to assess the effectiveness of a combined exercise and ACT intervention for chronic pain and will build on pilot work already undertaken. Participants with chronic pain (N=160) will be recruited from a hospital pain clinic and will be randomised to either a combined treatment group or a standalone exercise group. Both groups will complete an 8-week intervention, attending for treatment one day each week. The combined treatment will include ACT based psychology sessions delivered by a psychologist and supervised exercise activities (gym based and aquatic exercise) led by a physiotherapist. The standalone exercise group will participate in the same Physiotherapy led supervised exercise activities. Participants will be assessed pre-intervention, post-intervention and at 6-month follow up. The primary outcome will be pain interference. Secondary outcomes will include self-perception of change, pain intensity, self-efficacy, pain catastrophizing, fear avoidance, depression and anxiety. Physical activity including average daily step count, distance walked and active minutes will be measured using a FitBit ZipTM physical activity monitor. An embedded qualitative study will facilitate interpretation of the trial results. Linear mixed models on the outcome measures over time will be fitted to evaluate the effectiveness of both interventions. Qualitative data will be analysed using the Framework Analysis method. This RCT will inform patients and healthcare professionals regarding the effectiveness of these interventions and has the potential to positively impact the lives of people with chronic pain including increased activity engagement and enhanced quality of life.