Group Acceptance & Commitment Therapy for Pain in Crohn's Disease
Pain is a common symptom of inflammatory bowel disease (IBD) and has a significant impact on patient quality of life. Up to 70% of patients experience pain in active disease, and up to half (20-50%) of patients will experience pain in remission. Pain in IBD is widely recognised as a biopsychosocial construct, with visceral hypersensitivity, as well as depressive symptoms, anxiety, stress and fear-avoidance, correlating positively with IBD pain. There is an increasing understanding of the psychological interaction and the need for psychological management within IBD. Although ACT (Acceptance and Commitment Therapy) has not been used specifically for pain in IBD, it has become a regular therapy in the management of chronic pain, particularly in relation to improving functioning, quality of life and physical wellbeing and decreasing distress.
This study is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with Crohn’s disease (CD) and chronic abdominal pain to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with CD. We will investigate the acceptability of ACT to people with CD and chronic pain, specifically testing issues of eligibility, recruitment, retention rates, patient experience and performance of proposed outcome measures. This will inform the design of a subsequent large multi-centre randomised controlled trial (RCT) with long-term follow-up.
- To examine the feasibility of a study of ACT in people with CD and abdominal pain including recruitment and retention rates.
- To determine whether patients with CD and abdominal pain view group ACT as acceptable and credible.
- To determine whether the methods and procedures in treatment can be delivered with fidelity and integrity
RCT feasibility study with quantitative and qualitative evaluation
The study design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. We will invite participants aged 18 and over with a diagnosis of CD attending outpatient clinics at Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust to participate. With ~90 patients with CD attending the clinics each week, this represents one of the largest CD cohorts in the UK. Patients with CD attending the outpatients department will be screened for the presence of chronic pain using standard questionnaires. Individual cases will then be reviewed by a gastroenterologist to assess whether their IBD is stable and they are suitable for the study or whether their pain is part of an acute flare which necessitates a change in medical treatment. Only patients where it is thought pain is part of stable chronic disease will be selected for randomisation.
Summary of Findings
Feasibility assessment will include assessment of Study design, Intervention and Outcome measures.
3.2.1 Assessment of the study design
We will measure the success of the recruitment (recruitment rates: number of approached, eligible and consenting patients), participants’ willingness to be randomised (attrition rates) and to complete the study (follow-up rates). Refusal, withdrawal and dropout rates from the study will be recorded and calculated for both groups.
3.2.2 Assessment of the intervention
As this is a feasibility study, our primary outcomes are designed to assess this element. However, we will be collecting a range of secondary clinical outcomes to assess the intervention.
We will also be conducting Evaluation interviews about the intervention content and format.
3.2.3 Assessment of outcome measures
Initial estimates of the intervention efficacy will be assessed by participants completing a set of questionnaires.
Guy's and St Thomas' NHS Foundation Trust
King's College Hospital NHS Foundation Trust
Funding Body: Crohn's and Colitis UK
Period: March 2022 - April 2024