Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial

Matilda Cederberg, Sara Alsén, Lilas Ali, Inger Ekman, Kristina Glise, Ingibjörg H Jonsdottir, Hanna Gyllensten, Karl Swedberg, Andreas Fors, Matilda Cederberg, Sara Alsén, Lilas Ali, Inger Ekman, Kristina Glise, Ingibjörg H Jonsdottir, Hanna Gyllensten, Karl Swedberg, Andreas Fors

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 return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care.

Objective: The aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs.

Methods: A randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform.

Results: At the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave.

Conclusions: A person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave.

Trial registration: ClinicalTrials.gov NCT03404583; https://ichgcp.net/clinical-trials-registry/NCT03404583.

Keywords: anxiety; depression; intervention; mHealth; mobile phone; patient-centered care; person-centered care; randomized controlled trial; sickness absence; stress; telehealth.

Conflict of interest statement

Conflicts of Interest: None declared.

©Matilda Cederberg, Sara Alsén, Lilas Ali, Inger Ekman, Kristina Glise, Ingibjörg H Jonsdottir, Hanna Gyllensten, Karl Swedberg, Andreas Fors. Originally published in JMIR Mental Health (https://mental.jmir.org), 15.03.2022.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) diagram. ITT: intention-to-treat; PCC: person-centered care; PP: per-protocol.

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