Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome
PROMISE
1 other identifier
interventional
220
1 country
1
Brief Summary
The goal of the research project PROMISE is to translate the person-centred care (PCC) principles into an eHealth (the use of information and communication technologies for health) context. A developed PCC eHealth platform will be used as a tool to identify patients´ resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives. The PCC eHealth platform will not replace, but instead be used as add on treatment to usual care (guideline directed care).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedStudy Start
First participant enrolled
February 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 27, 2020
August 1, 2020
3 years
January 12, 2018
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite score of changes
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 6 months reduced sick leave and increased general self-efficacy by ≥ 5 units A patient is classified as deteriorated if: at 6 months increased sick leave or (if on full-time sick leave at inclusion reduced general self-efficacy by ≥ 5 units) Those who have neither deteriorated nor improved are considered unchanged
baseline, 3, 6, 12, 18, 24 months
Secondary Outcomes (12)
Sick leave
baseline, 3, 6, 12, 18, 24 months
General self-efficacy scale
baseline, 3, 6, 12, 18, 24 months
Health-related quality of Life (EQ-5D)
baseline, 3, 6, 12, 18, 24 months
Hospital anxiety and depression scale (HADS)
baseline, 3, 6, 12, 18, 24 months
Symptom burden (Shirom-Melamed Burnout Measure)
baseline, 3, 6, 12, 18, 24 months
- +7 more secondary outcomes
Study Arms (2)
Person-centred care at distance
EXPERIMENTALPerson-centred care at distance through an eHealth platform
Usual Care
NO INTERVENTIONEvidence-based care
Interventions
Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives
Eligibility Criteria
You may qualify if:
- Men and women fulfilling criteria for any of the following diagnoses: stress, depression or anxiety and on sick leave since ≤30 days
- Paid professional work, at least part time, during the last 9 months and willing to participate
You may not qualify if:
- Sick leave \>14 days for any of the above mentioned diagnoses during the last 3 months.
- Severe impairment that prevents patient from using the eHealth support
- No registered address
- Not willing to participate
- Any severe disease with an expected survival \<12 months
- Cognitive impairment
- Ongoing documented diagnosis of alcohol or drug abuse
- Other severe disease that can interfere with follow-up or if the intervention is assessed as a burden
- Patient participating in another conflicting randomized study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary health care
Gothenburg, Sweden
Related Publications (5)
Alsen S, Cederberg M, Fors A. A person-centred care intervention provided via eHealth to reduce fatigue in patients with common mental disorders - secondary outcome analysis from a randomized controlled trial. Scand J Prim Health Care. 2025 Jul 24:1-10. doi: 10.1080/02813432.2025.2533997. Online ahead of print.
PMID: 40702943DERIVEDCederberg M, Barenfeld E, Ali L, Ekman I, Goulding A, Fors A. A lowered threshold to partnerships: a mixed methods process evaluation of participants' experiences of a person-centred eHealth intervention. BMC Health Serv Res. 2023 Nov 2;23(1):1193. doi: 10.1186/s12913-023-10190-7.
PMID: 37919705DERIVEDAlsen S, Hadzibajramovic E, Jonsdottir IH, Ali L, Fors A. Effectiveness of a person-centred eHealth intervention in reducing symptoms of burnout in patients with common mental disorders - secondary outcome analysis of a randomized controlled trial. BMC Prim Care. 2023 Oct 19;24(1):210. doi: 10.1186/s12875-023-02172-9.
PMID: 37858032DERIVEDCederberg M, Alsen S, Ali L, Ekman I, Glise K, Jonsdottir IH, Gyllensten H, Swedberg K, Fors A. Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial. JMIR Ment Health. 2022 Mar 15;9(3):e30966. doi: 10.2196/30966.
PMID: 35289756DERIVEDCederberg M, Ali L, Ekman I, Glise K, Jonsdottir IH, Gyllensten H, Swedberg K, Fors A. 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. 2020 Sep 1;10(9):e037515. doi: 10.1136/bmjopen-2020-037515.
PMID: 32873675DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Fors, PhD
Institute of health and care sciences, Centre for person-centred care (GPCC)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2018
First Posted
January 19, 2018
Study Start
February 14, 2018
Primary Completion
January 31, 2021
Study Completion
June 30, 2022
Last Updated
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share