E-IMR: E-health added to face-to-face delivery of Illness Management & Recovery programme for people with severe mental illness, an exploratory clustered randomized controlled trial

Abstract

Background: E-mental health holds promise for people with severe mental illness, but has a limited evidence base. This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery Programme (e-IMR). Method: In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n = 60; 41 in intervention group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management, self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T 0 ), halfway (T 1 ), and at twelve months (T 2 ). The data were analysed using mixed model for repeated measurements in four models: in 1) we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled for interaction effects, and in 4) we performed sub-group analyses within the intervention group. Results: Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management (p =.01) and recovery (p =.02) at T 1 , and for general health perception (p =.02) at T 2 , all in favour of the intervention group. In model 2, the confounding covariate gender explained the effects at T 1 and T 2 , except for self-management. In model 3, the interacting covariate non-completer explained the effects for self-management (p =.03) at T 1 . In model 4, the sub-group analyses of e-IMR-users versus non-users showed no differences in effect. Conclusion: Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process evaluation of the intervention. Trial registration: The Dutch Trial Register (NTR4772)