Study design
Insomnia
MAY, RECRUITMENT
This randomized parallel, single-blinded clinical study enrolled 53 participants with MS who were randomly assigned (1:1) to attend ten, two-hour weekly sessions of MBSI-I or a one-hour counseling session on SH. Repeated assessments were performed at baseline, 10 and 16 weeks. The evaluator was blinded to treatment group assignment. The study was conducted at Griffin Hospital, a community hospital in the lower Naugatuck valley, in central CT, USA, in collaboration with the Yale Stress Center at the Yale School of Medicine in New Haven, CT. The study was approved by the Griffin Hospital Institutional Review Board (IRB) and registered on clinicaltrials.gov (NCT03949296) before initiating recruitment. The recruitment period commenced from May, 2019 to September, 2019.Participants were assigned to one of two cohorts: one comprised of small groups of six to 11 persons who attended ten weekly sessions of MBSI-I (Mindfulness Based Stress Intervention for Insomnia) and the other, similar groups of participants who attended one sleep hygiene session conducted by the Griffin Hospital Sleep Wellness Center staff. MBSI-I is an adaptation of MBSR. Eighty percent attendance at the MBSI-I program was considered good compliance. Because of the lower than expected number of participants at the end of the randomized portion of the study, participants from the sleep hygiene cohort were offered participation in the MBSI-I course and repeated 10 and 16 week assessments after the course, i.e., the expanded MBSI-I, or eMBSI-I cohort. This was done to increase the statistical power of the results.