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)

Introduction The 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 ap...

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Main Authors: Ingibjörg H Jonsdottir, Hanna Gyllensten, Lilas Ali, Andreas Fors, Karl Swedberg, Inger Ekman, Matilda Cederberg, Kristina Glise
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e037515.full
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author Ingibjörg H Jonsdottir
Hanna Gyllensten
Lilas Ali
Andreas Fors
Karl Swedberg
Inger Ekman
Matilda Cederberg
Kristina Glise
author_facet Ingibjörg H Jonsdottir
Hanna Gyllensten
Lilas Ali
Andreas Fors
Karl Swedberg
Inger Ekman
Matilda Cederberg
Kristina Glise
author_sort Ingibjörg H Jonsdottir
collection DOAJ
description Introduction The 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 analysis This 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 dissemination This 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 number NCT03404583.
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spelling doaj-art-a2c573610c1a4eb0a9dff1c802c210662025-01-07T13:10:08ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037515Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)Ingibjörg H Jonsdottir0Hanna Gyllensten1Lilas Ali2Andreas Fors3Karl Swedberg4Inger Ekman5Matilda Cederberg6Kristina Glise7School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenCentre for Person-Centred Care, University of Gothenburg, Gothenburg, SwedenRegion Västra Götaland, Sahlgrenska University Hospital, Psychiatric Department, Goteborg, SwedenResearch and Development, Primary Health Care, Region Västra Götaland, Gothenburg, SwedenInstitute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenInstitute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenInstitute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenThe Institute of Stress Medicine, Region Västra Götaland, Gothenburg, SwedenIntroduction The 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 analysis This 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 dissemination This 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 number NCT03404583.https://bmjopen.bmj.com/content/10/9/e037515.full
spellingShingle Ingibjörg H Jonsdottir
Hanna Gyllensten
Lilas Ali
Andreas Fors
Karl Swedberg
Inger Ekman
Matilda Cederberg
Kristina Glise
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)
BMJ Open
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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
url https://bmjopen.bmj.com/content/10/9/e037515.full
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