Digital Stress Management Intervention for Health Care Providers

May 27, 2025 updated by: Elin Børøsund, Oslo University Hospital
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.

Study Overview

Status

Active, not recruiting

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

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0588
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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)
An app-based program for stress management consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
Other Names:
  • Stress Management

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lise Solberg Nes, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Actual)

May 16, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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