- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05607758
Digital Stress Management Intervention for Health Care Providers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0588
- Oslo University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: App for Stress management
Participants will:
|
An app-based program for stress management consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from baseline to f-up month 3
|
|
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.
|
Change from baseline to f-up month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from baseline to f-up month 3
|
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). |
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
|
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). |
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
|
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.
|
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
|
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.
|
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
|
18 item scale measuring self-regulation.
Scale range: 18 to 90.
A higher score indicates higher self-regulatory fatigue
|
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
|
18 item scale measuring self-regulation.
Scale range: 18 to 90.
A higher score indicates higher self-regulatory fatigue
|
Change from baseline to f-up month 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention commentary
Time Frame: 3 months
|
A six item brief measure of participant's intervention reactions.
The first 3 items gauged participants' program perception on a scale from 1 to 5, with 5 indicating better perception.
The next 3 items were open ended questions: * What did you like best?
* What did you like the least?
* Suggestions for improvement?
|
3 months
|
|
Sleep
Time Frame: Change from baseline to f-up month 3
|
Four questions related to number of hours of sleep per 24 hours, how much sleep participants need to feel rested, experienced quality of sleep an impact of shift-work on sleep
|
Change from baseline to f-up month 3
|
|
Sleep
Time Frame: Change from baseline to f-up month 6
|
Four questions related to number of hours of sleep per 24 hours, how much sleep participants need to feel rested, experienced quality of sleep an impact of shift-work on sleep
|
Change from baseline to f-up month 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lise Solberg Nes, PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22/21663
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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