This study will assess the feasibility of a group-based Acceptance and Commitment Therapy (ACT) intervention to reduce the impact of abdominal pain and its associated psychological burden in people with Crohn’s disease (CD).
Background: Chronic abdominal pain is a common symptom for patients with Crohn's disease, causing significant negative impact on their daily quality of life. Moreover, the pain does not consistently corelate with their disease activity, with almost half of patients experiencing significant levels of pain in remission. This lack of association between the disease and one of the prevalent symptoms is distressing for patients, and causes difficulty with medical management, as the strategies are unsatisfactory. An alternative approach is emerging in the use of psychological techniques such as Acceptance and Commitment Therapy (ACT) for chronic pain treatment in other conditions. This feasibility trial aims to explore whether this approach could be used in this population.
Methods: A cross over randomised control trial with quantitative and qualitative evaluation will be conducted. We will recruit 48 patients to take part in three waves of an ACT based group intervention for chronic abdominal pain with specific adaptations tailored to its presentation in Crohn's disease. In each wave, we will randomise to an active group who will engage in the group intervention first, and a wait-list control group, who will start the intervention later. Both groups will complete measures at baseline, week 8-10 and week 24 after randomisation with the crossover arm completing two additional sets after their intervention. Separately, participants will be asked to take part in a qualitative feedback interview with the lead researcher to discuss their experiences. This data will be analysed by the research team and patient representatives.
Discussion: We will measure the success of the recruitment (recruitment rates number of approached, eligible and consenting patients), participants’ willingness to be randomised, and to complete the study (follow-up questionnaire rates). Refusal, withdrawal, and dropout rates from the study will be recorded and calculated for both groups.