Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease—Feasibility of a randomized controlled trial under pandemic circumstances

Abstract

IntroductionMind-body medicine (MBM) focuses on stress reduction and lifestyle changes. The primary objective of this pilot trial was to test study feasibility of a complex integrative MBM program for patients with Crohn's disease (CD), especially in rural regions, and under pandemic conditions.MethodsPatients were stratified and randomized to the intervention group (IG) or the control group (CG). The intervention included a weekly 6-h session for 10 weeks. The CG (waiting list) received an initial 90-min workshop and started the intervention 9 months later. The primary outcome for study feasibility was recruitment and retention rates, as well as reasons for drop-out. The trial took place in Bamberg, Germany (September 2020 to December 2021).ResultsTotally 700 members of the German Crohn's and Colitis Organization—DCCV—were contacted. A total of 15% (102/700; 95% CI 12–17%) expressed interest to participate. Following screening, 41% (95% CI 32–50) were randomized to IG (n = 22) and CG (n = 20). The patients were on average (±standard deviation) 48 ± 13 years old, 67% were female, and have been suffering from CD for 20 ± 12 years. Patients traveled 71.5 ± 48.7 km (range: 9–227 km) to the intervention with no differences between IG and CG. At the 6-month follow-up, 36/42 (86%, 95% CI 74–95%) participants completed final assessment and 19/22 (86%, 95% CI 70–100%) the intervention. The most important reasons for non-responding were work-related (12/60; 20%) and for or drop-out pandemic-related anxiety (3/6). No patient and staff member became infected with SARS-CoV-2 during the study.ConclusionThe feasibility of the MBM study was confirmed in terms of predefined recruitment and retention criteria, both despite difficult conditions (including the rural setting) and patients' fears associated with the pandemic. It was crucial to develop appropriate hygiene and safety concepts that enable chronically ill patients to participate in helpful group-based interventions even under pandemic conditions.Clinical trial registrationClinicalTrials.gov, identifier: NCT05182645.

Evaluation of a Multimodal Stress Management and Comprehensive Lifestyle Modification Program on Quality of Life and Gastrointestinal Symptoms in Patients with Crohn’s Disease: A Randomized Controlled Pilot Trial with 9-Month Follow-Up

“…So, the drop-out rates until 9-month follow-up-assessment (week 36) differed slightly between IG (0%) and CG (6%). Further information on treatment adherence and drop-out rate including reasons for dropping out was previously published [14].…”

“…Those in the IG were presumably not causally related to the intervention of the trial. More detailed information was published previously [14].…”

“…Second, to our knowledge, this is the only outpatient treatment program in Germany that is offered specifically for patients with IBD. The intervention’s content was composed of five of the seven most frequently indicated complementary and alternative medicine (CAM) procedures for patients with IBD in Germany [42] Third, a lifestyle modification and stress management intervention is considered as a rather save intervention, with no or few adverse events that may be caused by the intervention [14]. Fourth, we applied commonly used and validated measurement tools.…”

“…Exclusion criteria were a current highly acute course, a complete colectomy, severe mental illness (e.g., major depression, addiction, or schizophrenia), severe somatic comorbidities (e.g., diabetes, cancer), pregnancy and participation in stress reduction programs or clinical studies with psychological intervention during the study period. Detecting the possible recruitment rate was part of the study objective [14].…”

“…Subsequent analyses will address cytokine stimulation, stress test, interviews, confocal laser endo-microscopy, and microbiome parameters. Details of the trial design as well as the evaluation of the feasibility were published previously [14].…”