Digital Stress Management Intervention for Health Care Providers

Stress Clinical Trial

Official title:

Digital Stress Management Intervention for Health Care Providers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607758
• Other study ID #: 22/21663
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: Elin Børøsund, PhD
• Phone: 92667161
• Email: elin.borosund[@]rr-research.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Care Providers
• Psychological
• Stress

Intervention

Behavioral:
• StressProffen©™
An app-based program for stress management consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention commentary	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
Other	Sleep	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
Other	Sleep	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
Primary	The Perceived Stress Scale (PSS-14)	14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.	Change from baseline to f-up month 3
Primary	The Perceived Stress Scale (PSS-14)	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	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).	Change from baseline to f-up month 3
Secondary	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).	Change from baseline to f-up month 6
Secondary	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.	Change from baseline to f-up month 3
Secondary	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.	Change from baseline to f-up month 6
Secondary	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	Change from baseline to f-up month 3
Secondary	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	Change from baseline to f-up month 6