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Mental HealthPROMISENCT03404583

Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome

A study testing Person-centred care at distance through an eHealth platform in people with Mental Health, run by Göteborg University at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Person-centred care at distance through an eHealth platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteSweden
Study dates
14 Feb 2018to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Primary health care

    Gothenburg

Other trials in Sweden

About this study

Official title: Person-centred eHealth for Treatment and Rehabilitation of Severe Stress and Burnout Syndrome - a Randomized Controlled Trial in Primary Health Care

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).

Read the detailed description

A pilot study and collaboration between patients, relatives and professionals in the research program has clarified the need to develop a PCC eHealth platform. Previous research has shown that eHealth support, where the users are not involved in the process, has a low impact and has highlighted several limitations with respect to: patients' participation in the design process; its anchorage in the home and local environment and opportunities for communication rather than information. Therefore this study has a participatory design which assumes that all users (patients, relatives and health care professionals) are involved in the study design which facilitates implementation. An end-user perspective as a starting point increases the chances that users adapt a positive attitude towards the new system. Person-centred care combined with an eHealth support along the chain of health care showed a 4-fold chance of improved self-efficacy in combination with return to work or prior activity level after an event of acute coronary syndrome.

The aim of this project is that PCC can be delivered at distance and make health care more effective above and beyond usual care. Inclusion of the principles of PCC in an eHealth support for patients with stress, depression or anxiety will improve return to work rates, reduced relapse, reduce costs and improved self-efficacy.

In the PCC approach, the aims, capabilities and needs of each patient, will be the starting point. Self-care strategies will be reinforced and empowered.

This study is a randomized, open, parallel group intervention study where patients are eligible when they start their sick leave period due to stress, depression or anxiety. They will be asked about participation after being diagnosed and their sick leave has been approved.

Patients will be randomized into either the control or the intervention arm 1:1. The control group will receive usual care. The intervention group will receive usual care plus a PCC intervention through an eHealth platform. Randomization will be done through computer generated lists and stored in sealed envelopes.

Patients listed in primary care with a confirmed diagnosis of stress, depression or anxiety will be screened and sent an informing letter about the study from the chief at each centre. Specially trained registered nurses (RNs) will then screen patients against study inclusion and exclusion criteria and by phone contact eligible patients and inform the patient about the aims of the study and ask if they are interested to participate. If the patient wants to participate a consent form is sent to the patient and then returned to the RN. Written informed consent will then be obtained. Then the randomization procedure is performed which is stratified for age (≥ 50y) and diagnosis (stress, depression and anxiety) and the patient will be informed about the outcome by phone. Patients randomized to the intervention group will need a computer, smart phone or iPad to participate in the study.

Two dedicated full-time RNs follow the procedures closely. A monitor controls the protocol adherence. All case record forms, questionnaires and referrals will be constructed (for intervention and usual care groups).

Follow-up questionnaires on general self-efficacy, self-efficacy (self-care) quality of life, anxiety and depression, symptom burden and daily functional level will be sent out to all patients in both groups after 3,6,12,18 and 24 months after randomization.

Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in treatment guidelines and followed as usual at their local primary care centre.

Patients will be contacted by a RN who has received special training in PCC communication at distance through the eHealth platform, for an initial person-centred dialogue by phone. Based on the patient narrative patient´s goals, resources and needs are identified. The patient (sometimes maybe together with relatives) and the RN formulate a person-centred health plan. This plan is part of and will be up-loaded to the eHealth platform which also contains individual notes and information about stress, depression and anxiety. The plan will be the point of departure for the forthcoming dialogue at distance via the eHealth platform that the patient and the RN will have during the study period (6 months).

The eHealth support contains headings that may inspire the patient to make notes on "a good day" respectively "a bad day" and register daily health related status. The health plan contain three parts; 1. "My goal is to feel or be able to do". 2. "To be able to reach my goal I will." 3."Support I need to reach my goal". In the communication during the study period between the RN and patient, the personal health plan is discussed and any needs of reformulating the goals may be discussed. The overall goal is to help the patient to identify their own capabilities/resources such as a strong will, social relations etc. and formulate goals that help them increase their self-efficacy and to cope with their condition in daily life.

The RN presents the eHealth support for communication (computer, iPad, smart phone) and they agree on how they will be in contact thereafter. The RN invites the patient and activates their account where he/she can login via an individual user name and formulate, comment, evaluate or develop the health plan. Access to the diary will be password protected. The RN can see the patient´s account and make comments. The patient can add or delete staff or private persons that have access to the account, and the patient can also limit the access for each user invited.

Conditions
Mental Health
Being tested
Person-centred care at distance through an eHealth platform
Keywords
Person-centred care
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-centred care at distance through an eHealth platformBehavioural

    Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives

Study groups in NCT03404583
Study groupRoleWhat they receive
Person-centred care at distanceExperimentalPerson-centred care at distance through an eHealth platform
Receives: Behavioral: Person-centred care at distance through an eHealth platform
Usual CareNo interventionEvidence-based care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, 3, 6, 12, 18, 24 months

Secondary outcomes (12)
  1. Sick leave

    Grade of sick leave

    Measured: baseline, 3, 6, 12, 18, 24 months

  2. General self-efficacy scale

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  3. Health-related quality of Life (EQ-5D)

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  4. Hospital anxiety and depression scale (HADS)

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  5. Symptom burden (Shirom-Melamed Burnout Measure)

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  6. Perceived stress scale (PSS)

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  7. Self-rated burnout syndrome (s-UMS)

    Questionnaire

    Measured: baseline, 3, 6, 12, 18, 24 months

  8. Health care utilization

    Health care utilization

    Measured: 3, 6, 12, 18, 24 months

  9. Incremental cost-utility ratios

    Incremental cost-utility ratios

    Measured: 3, 6, 12, 18, 24 months

  10. Multidimensional fatigue symptom inventory (MFI-20)

    Questionnaire

    Measured: 3, 6, 12, 18, 24 months

  11. Sheehan disability scale (SDS)

    Questionnaire

    Measured: 3, 6, 12, 18, 24 months

  12. Self-efficacy (self-care)

    Questionnaire

    Measured: 3, 6, 12, 18, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start14 Feb 2018
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03404583
Sponsor's protocol ID
PROMISE
Acronym
PROMISE
Status last verified
Aug 2020
First submitted
12 Jan 2018
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harvey BP, Kebede TT, Fors A, Cederberg M, Alsen S, Barenfeld E, van Dijk ML, Gyllensten H. Group-based trajectory modelling of multiple health outcomes in a cost-consequence framework: a randomized controlled trial of a remote person-centred care intervention for people with common mental disorders in Sweden. J Patient Rep Outcomes. 2026 Mar 20;10(1):54. doi: 10.1186/s41687-026-01043-y.

    PubMed 41860652
  • 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. 2026 Dec;44(1):1-10. doi: 10.1080/02813432.2025.2533997. Epub 2025 Jul 24.

    PubMed 40702943
  • Cederberg 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.

    PubMed 37919705
  • Alsen 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.

    PubMed 37858032
  • Cederberg 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.

    PubMed 35289756
  • Cederberg 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.

    PubMed 32873675

Questions about this trial

What is this clinical trial studying?

A study testing Person-centred care at distance through an eHealth platform in people with Mental Health, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite score of changes (time frame: baseline, 3, 6, 12, 18, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03404583, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

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