Abstract
OBJECTIVES: Psychological and behavioral therapies are being increasingly used for symptom management in patients with irritable bowel syndrome (IBS). The aims of this study were to compare two delivery modes for a comprehensive self-management (CSM) intervention, primarily by telephone vs. entirely in person, and to compare each with usual care (UC). METHODS: Adults with IBS were recruited through community advertisement. Subjects (N=188) were randomly assigned to three groups: one in which all nine weekly CSM sessions were delivered in person, one in which six of the nine sessions were conducted over telephone, and one in which subjects received UC. Primary outcome measures were a gastrointestinal (GI) symptom score based on six symptoms from a daily diary and disease-specific quality of life (QOL). These and other outcomes were assessed at baseline and at 3, 6, and 12 months after randomization. Mixed model analyses tested for differences between the three groups in each outcome variable at the three follow-up occasions, controlling for the baseline level of each outcome. RESULTS: Both GI symptom score and QOL showed significantly greater improvement in the two CSM groups than in the UC group (P<0.001), with the magnitude of this difference being quite similar for the three follow-up time points. The two CSM groups experienced a very similar degree of improvement, and there were no statistically significant differences between the two. CONCLUSIONS: A CSM program is efficacious whether delivered primarily by telephone or totally in person, and there is no evidence that replacing six of the in-person sessions by telephone sessions reduces the efficacy of the intervention.