Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|King's College London|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dr Wladyslawa Czuber-Dochan|
|Principal Investigator Affiliation||KCL|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Chronic Pain, Crohn Disease|
Aims: This study aims to assess the feasibility of ACT for reducing the impact of abdominal pain and its associated psychological burden in people with Crohn's disease (CD). The study 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. Design and setting: The design is a crossover randomised controlled trial of ACT versus treatment-as-usual (TAU) in people with CD and chronic abdominal pain. The researchers 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 recruited. Sample size and recruitment: This is a feasibility study and power calculations for a treatment effect are not applicable. Based on an expected follow-up rate of at least 75%, a two-sided confidence interval will extend no more than 12.5% of the observed proportion with a sample size of 48 patients, thus providing adequate precision estimates. Based on pilot work in the IBD clinics and our previous experience of running RCTs for psychological therapy in IBD, the researchers conservatively estimate that 25% of people approached will be both willing and eligible to participate. As such, a total of 192 people will be approached to meet the recruitment target. WCD will chair biweekly study meetings where recruitment will be reviewed and intensified if falling behind this trajectory. Randomisation: Participants will be randomly allocated (1:1) to the intervention or TAU control group using a web-based randomisation service, which employs block randomisation with randomly varying block sizes. Randomisation will be stratified by male/female sex. The researcher analysing the data will not be able to access the data until final database lock. Intervention: Half of the cohort (n=24) will be randomised initially to TAU, which will comprise usual care from the CD team and GP but no specific pain intervention except a CCUK information sheet on pain in CD. After completing 24 weeks of TAU, these patients will then crossover to the intervention. The other half (n=24) will be randomised initially to the intervention group. In addition to TAU, the intervention group will undergo eight 90-minute sessions of weekly ACT in groups of 8 patients, all led by a single clinical psychologist accredited in ACT. The course is based on contemporary ACT models and tailored toward people with IBD with an emphasis on reducing the impact of pain on functioning and quality of life. The research team will develop a manual and observe the sessions for assessment of fidelity. The manual will be adapted from one developed by co-applicant AD for use with people with IBD. It will be peer-reviewed by experienced ACT practitioners to ensure adherence to the model. Treatment commences with the therapist aiming to foster the therapeutic alliance; exploring the developing of chronic pain; and explaining the treatment model. Subsequent sessions will include exercises to increase patients' awareness of the long-term consequences of struggling to control pain; their willingness to experience pain; the development of personal value-based goals and their engagement in these. Treatment finishes with a review of progress and plans for barriers in future. Patients will be given weekly homework tasks to develop their individual value-based goals and explore barriers that appear for them. The aim of the sessions is to increase patients' awareness of misplaced control strategies and to relinquish these and to increase their value-based activities. The therapist will maintain a log of completed and non-completed sessions and any adverse events. The therapist will receive weekly supervision with an experienced ACT therapist (AD) to maintain adherence to the treatment protocol; to discuss issues arising from sessions; and plan for subsequent sessions. Any current treatment for pain will continue and be recorded. Changes to analgesia during the study are not restricted and will likewise be recorded. People randomised initially to the intervention group will not subsequently undergo transfer to the TAU group, as outcomes such as pain may already have been improved by the intervention.
Experimental: Intervention arm
Patients randomised into Group 1 will begin the 8 week group first.
Other: Control crossover group
Patients randomised into Group 2 will act as the control for the first 8 weeks and then cross over into the intervention arm.
Behavioral: - Acceptance and commitment therapy (ACT)
8 weekly 2 hour sessions of ACT group for CD patients with chronic pain. Manual available on request
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.