Health Care ProvidersNCT05607758
Digital Stress Management Intervention for Health Care Providers
A study testing StressProffen©™ in people with Health Care Providers and Stress, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose with this study is to test if the app-based stress management program StressProffen, can be of interest and support for stress management among health care providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Providers, Stress, Psychological
- What is being tested?
- StressProffen©™
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteNorway
- Study dates
- 10 Nov 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health care providers (included but not restricted to, registered nurses, physicians, physiotherapists, occupational therapists, dietitians, social workers, health workers).
- Working with patient treatment or follow up at Oslo University Hospital
- Having their own smart phone or tablet
- Being able to write/read/speak Norwegian
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose with this study is to test if the app-based stress management program StressProffen, can be of interest and support for stress management among health care providers.
Read the detailed description
For health care providers, work-related stress can be a major challenge that can lead to frustration, lower motivation, reduced quality of life and burnout, and the last year's COVID-19 pandemic particularly emphasized the challenges in the stressful everyday life faced by health care providers.
There are, however, interventions that can be of support, both for the prevention of stress and for coping with stress in challenging situations, and in recent years there has also been an increased focus on stress in working life in this setting. Several studies have also recently been carried out which aim to deliver such interventions via applications (apps) to promote employees' physical and mental health, as well as their ability to cope with stress. However, there is a need for more research in the field, especially with a focus that content in such apps should be based on evidence-based theory, and that interviews and a similar qualitative approach should be included in studies to gain increased insight into the need for and usefulness of digital tools among health care providers.
This study will therefore test the effect of an app-based program for stress management, StressProffen, among health care providers, in a single arm study. The app contains 10 modules distributed over four weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises.
StressProffen was initially developed and tested for stress management in patients with cancer, with good results. Among other things, a randomized controlled trial showed a statistically significant reduction in perceived stress, anxiety, depression and self-regulation fatigue, as well as increased health-related quality of life, for participants in the intervention group compared to the control group. The aim of this study is to test whether StressProffen can be of interest and support for stress management among health care providers.
- Conditions
- Health Care Providers, Stress, Psychological
- Being tested
- StressProffen©™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StressProffen©™Behavioural
Also called Stress Management
An app-based program for stress management consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
| Study group | Role | What they receive |
|---|---|---|
| App for Stress management | Experimental | Participants will:
* Participate in a physical introduction to the app-based stress management program
* Get access to the app-based program, and a new module every third day (total 10 modules). The app consists of stress management education, cognitive behavioral interventions and relaxation training exercises.
* Receive two phone follow-up calls from study personnel (about 3 and 6 weeks after the physical introduction) Receives: Behavioral: StressProffen©™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Perceived Stress Scale (PSS-14)
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
Measured: Change from baseline to f-up month 3
The Perceived Stress Scale (PSS-14)
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
Measured: Change from baseline to f-up month 6
Secondary outcomes (6)
The Hospital Anxiety and Depression Scale (HADS)
14 item scale measuring anxiety and depression. The Scale has a total score with a scale range of 0 to 42 and an anxiety (HADS-A) and a depression (HADS-D) subscale, both with scale range of 0 to 21.
Sub scale scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: Change from baseline to f-up month 3
The Hospital Anxiety and Depression Scale (HADS)
14 item scale measuring anxiety and depression. The Scale has a total score with a scale range of 0 to 42 and an anxiety (HADS-A) and a depression (HADS-D) subscale, both with scale range of 0 to 21.
Sub scale scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: Change from baseline to f-up month 6
SF-36 Item Short Form Health Survey (RAND-36 version)
36 item scale measuring health related quality of life (HRQoL). The scale has 8 subscales and 1 single item score. Scale and single item range: 0 to 100. Higher scores indicate higher HRQoL.
Measured: Change from baseline to f-up month 3
SF-36 Item Short Form Health Survey (RAND-36 version)
36 item scale measuring health related quality of life (HRQoL). The scale has 8 subscales and 1 single item score. Scale and single item range: 0 to 100. Higher scores indicate higher HRQoL.
Measured: Change from baseline to f-up month 6
The Self-Regulatory Fatigue-18 (SRF-18)
18 item scale measuring self-regulation. Scale range: 18 to 90. A higher score indicates higher self-regulatory fatigue
Measured: Change from baseline to f-up month 3
The Self-Regulatory Fatigue-18 (SRF-18)
18 item scale measuring self-regulation. Scale range: 18 to 90. A higher score indicates higher self-regulatory fatigue
Measured: Change from baseline to f-up month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start10 Nov 2022
- Primary completion16 May 2025
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care ProvidersStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elin Børøsund, Oslo University Hospital
- Investigators
- Lise Solberg Nes, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607758
- Sponsor's protocol ID
- 22/21663
- Status last verified
- May 2025
- First submitted
- 2 Nov 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Stress Management Intervention for Health Care Providers
- ClinicalTrials.gov ID
- NCT05607758
- Acronym / sponsor ID
- 22/21663
- Conditions
- Health Care Providers, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose with this study is to test if the app-based stress management program StressProffen, can be of interest and support for stress management among health care providers.
Detailed description
For health care providers, work-related stress can be a major challenge that can lead to frustration, lower motivation, reduced quality of life and burnout, and the last year's COVID-19 pandemic particularly emphasized the challenges in the stressful everyday life faced by health care providers.
There are, however, interventions that can be of support, both for the prevention of stress and for coping with stress in challenging situations, and in recent years there has also been an increased focus on stress in working life in this setting. Several studies have also recently been carried out which aim to deliver such interventions via applications (apps) to promote employees' physical and mental health, as well as their ability to cope with stress. However, there is a need for more research in the field, especially with a focus that content in such apps should be based on evidence-based theory, and that interviews and a similar qualitative approach should be included in studies to gain increased insight into the need for and usefulness of digital tools among health care providers.
This study will therefore test the effect of an app-based program for stress management, StressProffen, among health care providers, in a single arm study. The app contains 10 modules distributed over four weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises.
StressProffen was initially developed and tested for stress management in patients with cancer, with good results. Among other things, a randomized controlled trial showed a statistically significant reduction in perceived stress, anxiety, depression and self-regulation fatigue, as well as increased health-related quality of life, for participants in the intervention group compared to the control group. The aim of this study is to test whether StressProffen can be of interest and support for stress management among health care providers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App for Stress management | Experimental | Behavioral: StressProffen©™Participants will: * Participate in a physical introduction to the app-based stress management program * Get access to the app-based program, and a new module every third day (total 10 modules). The app consists of stress management education, cognitive behavioral interventions and relaxation training exercises. * Receive two phone follow-up calls from study personnel (about 3 and 6 weeks after the physical introduction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Health care providers (included but not restricted to, registered nurses, physicians, physiotherapists, occupational therapists, dietitians, social workers, health workers).
- Working with patient treatment or follow up at Oslo University Hospital
- Having their own smart phone or tablet
- Being able to write/read/speak Norwegian
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StressProffen©™Also: Stress ManagementAn app-based program for stress management consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training. | Behavioural | App for Stress management |
Primary outcome
The Perceived Stress Scale (PSS-14)
Time frame: Change from baseline to f-up month 3
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
The Perceived Stress Scale (PSS-14)
Time frame: Change from baseline to f-up month 6
14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.
6 secondary outcomes
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to f-up month 3
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to f-up month 6
SF-36 Item Short Form Health Survey (RAND-36 version)
Time frame: Change from baseline to f-up month 3
SF-36 Item Short Form Health Survey (RAND-36 version)
Time frame: Change from baseline to f-up month 6
The Self-Regulatory Fatigue-18 (SRF-18)
Time frame: Change from baseline to f-up month 3
The Self-Regulatory Fatigue-18 (SRF-18)
Time frame: Change from baseline to f-up month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Solberg Nes, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StressProffen©™ in people with Health Care Providers and Stress, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Perceived Stress Scale (PSS-14) (time frame: Change from baseline to f-up month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.