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Active, Not Recruiting

NCT Number: NCT05607758

Digital Stress Management Intervention for Health Care Providers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Health Care Providers Psychological Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University hospital

Oslo, 0588, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StressProffen©™

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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

  6. 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

Other outcomes

  1. 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?

  2. 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

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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