Patient-tailored modular treatment of multiple functional somatic syndromes (STreSS-5): Observational cohort study of 174 consecutive patients

Background Various psychological and pharmacological interventions are used to treat severe multisystem functional somatic disorders (FSD). The use of patient-tailored treatment strategies taking individual problems, underlying causes and patient preferences into account may potentially increase patient engagement and enhance overall treatment effect. In this study we therefore aimed to test the feasibility of a patient-tailored modular treatment for patients with severe FSD. Methods This is an uncontrolled cohort study (STReSS-5) on patients with multisystem FSD between 20 and 60 years old. Patients were recruited between 2015 and 2016. Measurements were obtained at baseline, before and after each treatment module, and at end-point (58 weeks after baseline). Treatments modules were: 1) Assessment and group-based psycho-education, 2) Group-based psychotherapy (either Acceptance and Commitment Therapy, ACT, or Mindfulness Based Stress Reduction, MBSR), and 3) a second course Results In all, 174 were included and completed the first psycho-education module. Of those, 144 patients were referred to the second module, either ACT or MBSR. Next, 53 was referred to the third treatment module, ACT or MBSR. The main hypothesis was not met (ITT 0.39, 95% CI [0.30; 047]). Conclusion This patient-tailored modular treatment did not prove feasible in terms of improving treatment effect further compared to previous trials (STReSS 1,2,3, and 4). Plans on testing this program in a larger controlled trial is terminated.