Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)

Abstract

IntroductionThe number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.Methods and analysisThis study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.Ethics and disseminationThis study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.Trial registration numberNCT03404583.

Self-Efficacy to Manage Chronic Disease (SEMCD) scale: translation and evaluation of measurement properties for a swedish version

“…The translation and cultural adaptation of the SEMCD was performed according to international recommendations [ 31 ]. The data used in this study derived from baseline assessments from two different interventional studies: a single-center quasi-experimental study evaluating a person-centered practice after surgery for patients with pituitary tumors (PT) [ 32 ]; hereafter, this sample is referred to as the PT-cohort; and a randomized controlled study evaluating the effects of a person-centered eHealth intervention (combined digital platform and phone support) for patients on sick leave due to common mental disorders (CMD) [ 16 , 33 ]; hereafter, this sample is referred to as the CMD-cohort. …”

“…a randomized controlled study evaluating the effects of a person-centered eHealth intervention (combined digital platform and phone support) for patients on sick leave due to common mental disorders (CMD) [ 16 , 33 ]; hereafter, this sample is referred to as the CMD-cohort.…”

“…Exclusion criteria were: sick leave > 14 days due to depression, anxiety disorders, stress reactions and disorders during the past 3 months; severe impairments impeding use of the eHealth intervention; ongoing alcohol or drug abuse; severe disease with an expected survival of < 12 months or that could interfere with follow-up or if the intervention was assessed as a burden; or the patient was participating in a conflicting study. Details about the data collection can be found in Cederberg et al [ 16 , 33 ].…”

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

“…In addition to usual care, the intervention group received PCC through a web-based platform and telephone support during the 6-month intervention period. A detailed description of the intervention has been published elsewhere [ 44 ]. The intervention aims to operationalize person-centered ethics by safeguarding the relational aspects of personhood and care according to PCC [ 39 , 45 ].…”

The interactive work of narrative elicitation in person‐centred care: Analysis of phone conversations between health care professionals and patients with common mental disorders

“…The present study is part of a larger randomized controlled trial (RCT) evaluating the effects of remote PCC as additional support, complementary to usual care, for patients on sick leave due to common mental disorders (CMDs). 30 The RCT took place in an urban region in Sweden, and patients were recruited from nine primary health care centres. The intervention was administered remotely, through access to an interactive digital platform and through phone support with HCPs trained in PCC.…”