A randomized pilot study of Rhythms And You (RAY): An internet-based program for bipolar disorder administered with and without clinical helper support in primary care.

Abstract Background Rhythms And You (RAY) is an online intervention for bipolar disorders (BD) based on Interpersonal and Social Rhythm Therapy. We examined RAY's feasibility and acceptability for individuals with BD recruited from primary care. Because online interventions may be more effective when paired with human support, we evaluated RAY with and without weekly brief (∼5 min) calls from clinical helpers (CH). Methods Participants (n = 47) meeting criteria for BD I, II or other specified BD, presenting for primary care, were randomly assigned to RAY, RAY-CH, or Adjunctive Reading Material (ARM) control. RAY consisted of 12 weekly online modules. ARM consisted of 12 weekly emails. Participants were assessed at baseline, 4, 8, and 12 weeks. Results RAY showed high completion rates and Client Satisfaction Questionnaire scores (36/47, 77% and 25.1 ± 5.5, respectively; no group differences). Effect sizes for RAY- CH ranged from small [Internal State Scale-Activation Subscale (ISS-ACT); d = 0.3] to large [SF-12 Mental Health Composite Score (SF-12 MHC); d = 1.3]. ARM also showed moderate effects (ISS-ACT d = 0.7; Quick Inventory of Depressive Symptoms, d = 0.8). SF-12 MHC scores showed a time*group interaction (F = 2.38, df = 6,32, p = 0.05) favoring RAY-CH. Number of logins trended toward significant association with improved social rhythm regularity (F = 4.09, df = 1, 17, p = 0.06). Limitations Sample size is small, limiting conclusions that can be drawn. Conclusions Remote delivery of RAY for individuals with BD is feasible and acceptable. More time spent engaged in RAY was associated with greater improvement in social rhythm regularity. Preliminary evidence suggests adding brief human support to RAY may yield better outcomes.