Accepted for/Published in: JMIR Mental Health
Date Submitted: Jun 4, 2021
Date Accepted: Nov 23, 2021
Effects of a person-centred eHealth intervention for patients on sick leave due to common mental disorders (PROMISE): An open randomised controlled trial
ABSTRACT
Background:
Sick leave due to common mental disorders (CMDs) is a public health problem in several countries including Sweden. Given that symptom relief does not necessarily correspond to RTW, healthcare interventions focusing on factors that have proven important to influence the RTW process; such as self-efficacy and a specific focus on RTW, are warranted. Self-efficacy is also a central concept in person-centred care (PCC).
Objective:
To evaluate the effects of a person-centred eHealth intervention for patients on sick leave due to common mental disorders.
Methods:
A randomised controlled trial of 209 patients allocated to either a control (n=107) or intervention group (n=102) was conducted. The control group received usual care while the intervention group received usual care with addition of a person-centred eHealth intervention. The intervention built on PCC principles and consisted of phone support and an interactive digital platform. The primary outcome was a composite score of change in general self-efficacy (GSE) and level of sick leave at a 6-month follow-up. An intention-to-treat (ITT) analysis included all participants and a per-protocol (PP) analysis consisted of those using both the phone support and the digital platform.
Results:
At a 3-month follow-up, in the ITT analysis, more patients in the intervention group improved on the composite score than the control group (19.6%, n=20 versus 9.3%, n=10, odds ratio (OR) 2.37, 95% confidence interval (CI): 1.05; 5.34, P=.038). At 6-month follow-up, the difference was no longer significant between the groups (31.0%, n=31 versus 23.4%, n=25, OR 1.47, CI: 0.80; 2.73, P=.218). In the PP analysis a significant difference was observed between the intervention and control groups at the 3-month follow-up (21.2%, n=18 versus 9.3%, n=10, OR 2.6, CI: 1.13; 6.00, P=.024), but not at 6 months (35.7%, n=30 versus 23.4%, n=25, OR 1.8, CI: 0.97; 3.43, P=.063). Changes in GSE drove the effects in the composite score and the intervention did not affect the level of sick leave.
Conclusions:
A person-centred eHealth intervention for patients on sick leave due to CMDs improves self-efficacy but does not affect the level of sick leave. Clinical Trial: The trial was registered in the ClinicalTrials.gov (Identifier NCT03404583)
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