Internet-Based Intervention for Occupational Stress Among Medical Professionals (Med-Stress)

November 3, 2020 updated by: Ewelina Smoktunowicz, University of Social Sciences and Humanities, Warsaw

Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial

The aim of this study is to assess the efficacy of internet intervention for reduction of occupational stress and its negative consequences (job burnout, depression) among medical professionals through the enhancement of the resources that are critical for coping with stress: self-efficacy and perceived social support.

Study Overview

Detailed Description

Medical professionals are at high risk for job stress and burnout. Research show that the negative effects of stress can be reduced through strengthening personal resources such as self-efficacy and perceived social support. In line with cultivation and enabling hypotheses (Schwarzer & Knoll, 2007; Benight & Bandura, 2004) either self-efficacy cultivates perceived support, or rather perceived support enables self-efficacy. This study aims at testing both hypotheses in experimental design by applying them as a theoretical framework for the Med-Stress: evidence-based, CBT-framed internet intervention to foster resource accumulation among medical professionals.

The effectiveness of intervention will be tested in a four-arm randomized controlled trial comparing the effects of: 1) self-efficacy and perceived support sequential enhancement (cultivation hypothesis), 2) perceived support and self-efficacy sequential enhancement (enabling hypothesis), 3) only self-efficacy, and 4) only social support enhancement (controls). Primary outcomes are job stress and burnout, secondary outcomes include work engagement, depression, and secondary traumatic stress. Self-efficacy and perceived support are expected to mediate the relationships between condition assignment and outcomes. Assessments include baseline (T1), three- or six-weeks post-test (depending on the condition, T2), as well as six- and twelve-months follow-ups (T3, T4). Intervention effect sizes and between-groups comparisons at post-test and follow-ups will be calculated.

This study will contribute to the findings on the role of personal resources in the development of job stress and burnout by demonstrating the cultivation vs enabling effects of self-efficacy and perceived social support.

Study Type

Interventional

Enrollment (Actual)

1240

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

      • Warsaw, Poland, 00-864
        • SWPS University of Social Sciences and Humanities

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of at least 18 years
  • Professionally active medical providers
  • Internet connection

Exclusion Criteria:

  • No access to a device with Internet connection

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Efficacy and Perceived Social Support
The condition reflects cultivation hypothesis and consists of 2 sequential modules with self-efficacy enhancement module (SE) preceding perceived social support enhancement module (SS). Each module is comprised of 3 evidence-based, CBT-framed exercises: 1) SE: mastery experience, vicarious experience, and action planning, 2) SS: received support & cognitive distortions, social skills & peer support, action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 6 weeks, 1 week per exercise.
Experimental: Perceived Social Support and Self-Efficacy
The condition reflects enabling hypothesis and consists of 2 sequential modules with perceived social support enhancement module (SS) preceding self-efficacy enhancement module (SE). Each module is comprised of 3 evidence-based, CBT-framed exercises: 1) SS: received support & cognitive distortions, social skills & peer support, and action planning, 2) SE: mastery experience, vicarious experience, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 6 weeks, 1 week per exercise.
Active Comparator: Self-Efficacy
The condition consists of self-efficacy enhancement module (SE) and is comprised of 3 evidence-based, CBT-framed exercises: mastery experience, vicarious experience, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 3 weeks, 1 week per exercise.
Active Comparator: Perceived Social Support
The condition consists of perceived social support enhancement module (SS) and is comprised of 3 evidence-based, CBT-framed exercises: received support & cognitive distortions, social skills & peer support, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 3 weeks, 1 week per exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Perceived Stress Scale 14 (PSS-14)
Time Frame: Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)
The PSS-14 is a measure of perceived stress. It consists of 14 items with response scale ranging from 0 to 4. Higher total score represents higher perceived stress. Instruction was adapted to refer to work-related stress.
Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)
Change on Perceived Stress Scale 14 (PSS-14)
Time Frame: Change from baseline on PSS-14 (6 months)
The PSS-14 is a measure of perceived stress. It consists of 14 items with response scale ranging from 0 to 4. Higher total score represents higher perceived stress. Instruction was adapted to refer to work-related stress.
Change from baseline on PSS-14 (6 months)
Change on Perceived Stress Scale 14 (PSS-14)
Time Frame: Change from baseline on PSS-14 (12 months)
The PSS-14 is a measure of perceived stress. It consists of 14 items with response scale ranging from 0 to 4. Higher total score represents higher perceived stress. Instruction was adapted to refer to work-related stress.
Change from baseline on PSS-14 (12 months)
Change on Oldenburg Burnout Inventory (OLBI)
Time Frame: Change from baseline on OLBI (3 or 6 weeks depending on the study condition)
The OLBI is a measure of job burnout. It consists of 16 items with response scale ranging from 1 to 4. The questionnaire consists of two subscales: exhaustion and disengagement, To compute total score subscales are summed. Higher total score represents higher job burnout.
Change from baseline on OLBI (3 or 6 weeks depending on the study condition)
Change on Oldenburg Burnout Inventory (OLBI)
Time Frame: Change from baseline on OLBI (6 months)
The OLBI is a measure of job burnout. It consists of 16 items with response scale ranging from 1 to 4. The questionnaire consists of two subscales: exhaustion and disengagement, To compute total score subscales are summed. Higher total score represents higher job burnout.
Change from baseline on OLBI (6 months)
Change on Oldenburg Burnout Inventory (OLBI)
Time Frame: Change from baseline on OLBI (12 months)
The OLBI is a measure of job burnout. It consists of 16 items with response scale ranging from 1 to 4. The questionnaire consists of two subscales: exhaustion and disengagement, To compute total score subscales are summed. Higher total score represents higher job burnout.
Change from baseline on OLBI (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Utrecht Work Engagement Scale (UWES-3)
Time Frame: Change from baseline on UWES-3 (3 or 6 weeks depending on the study condition)
The UWES-3 is a measure of work engagement. It consists of 3 items with response scale ranging from 0 to 6. Higher total score represents higher work engagement.
Change from baseline on UWES-3 (3 or 6 weeks depending on the study condition)
Change on Utrecht Work Engagement Scale (UWES-3)
Time Frame: Change from baseline on UWES-3 (6 months)
The UWES-3 is a measure of work engagement. It consists of 3 items with response scale ranging from 0 to 6. Higher total score represents higher work engagement.
Change from baseline on UWES-3 (6 months)
Change on Utrecht Work Engagement Scale (UWES-3)
Time Frame: Change from baseline on UWES-3 (12 months)
The UWES-3 is a measure of work engagement. It consists of 3 items with response scale ranging from 0 to 6. Higher total score represents higher work engagement.
Change from baseline on UWES-3 (12 months)
Change on Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)
The PHQ-9 is a measure of depression. It consists of 9 items with response scale ranging from 0 to 3. Higher total score represents higher depression.
Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)
Change on Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline on PHQ-9 (6 months)
The PHQ-9 is a measure of depression. It consists of 9 items with response scale ranging from 0 to 3. Higher total score represents higher depression.
Change from baseline on PHQ-9 (6 months)
Change on Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline on PHQ-9 (12 months)
The PHQ-9 is a measure of depression. It consists of 9 items with response scale ranging from 0 to 3. Higher total score represents higher depression.
Change from baseline on PHQ-9 (12 months)
Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time Frame: Change from baseline on PCL-5 (3 or 6 weeks depending on the study condition)
The PCL-5 is a measure of posttraumatic stress disorder. It consists of 20 items with response scale ranging from 0 to 4. The questionnaire consists of four subscales: intrusions, avoidance, negative alterations in cognition and mood, and arousal. To compute total score subscales are summed. Higher total score represents higher posttraumatic stress disorder. Instruction was adapted to refer to work-related secondary traumatic stress.
Change from baseline on PCL-5 (3 or 6 weeks depending on the study condition)
Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time Frame: Change from baseline on PCL-5 (6 months)
The PCL-5 is a measure of posttraumatic stress disorder. It consists of 20 items with response scale ranging from 0 to 4. The questionnaire consists of four subscales: intrusions, avoidance, negative alterations in cognition and mood, and arousal. To compute total score subscales are summed. Higher total score represents higher posttraumatic stress disorder. Instruction was adapted to refer to work-related secondary traumatic stress.
Change from baseline on PCL-5 (6 months)
Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time Frame: Change from baseline on PCL-5 (12 months)
The PCL-5 is a measure of posttraumatic stress disorder. It consists of 20 items with response scale ranging from 0 to 4. The questionnaire consists of four subscales: intrusions, avoidance, negative alterations in cognition and mood, and arousal. To compute total score subscales are summed. Higher total score represents higher posttraumatic stress disorder. Instruction was adapted to refer to work-related secondary traumatic stress.
Change from baseline on PCL-5 (12 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
Time Frame: Change from baseline on WSBSES (3 or 6 weeks depending on the study condition)
The WSBSES is a measure of self-efficacy to cope with work stress and job burnout. It consists of 28 items with the response scale ranging from 1 to 7. Higher total score represents higher self-efficacy.
Change from baseline on WSBSES (3 or 6 weeks depending on the study condition)
Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
Time Frame: Change from baseline on WSBSES (6 months)
The WSBSES is a measure of self-efficacy to cope with work stress and job burnout. It consists of 28 items with the response scale ranging from 1 to 7. Higher total score represents higher self-efficacy.
Change from baseline on WSBSES (6 months)
Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
Time Frame: Change from baseline on WSBSES (12 months)
The WSBSES is a measure of self-efficacy to cope with work stress and job burnout. It consists of 28 items with the response scale ranging from 1 to 7. Higher total score represents higher self-efficacy.
Change from baseline on WSBSES (12 months)
Change on Berlin Social Support Scales (BSSS), Subscale 3
Time Frame: Change from baseline on BSSS, Subscale 3 (3 or 6 weeks depending on the study condition)
The BSSS Subscale 3 measures social support seeking. Instruction and rating scale ware adapted to refer to social support self-efficacy. It consists of 5 items with response scale ranging from 1 to 7. Higher total score represents higher social support self-efficacy.
Change from baseline on BSSS, Subscale 3 (3 or 6 weeks depending on the study condition)
Change on Berlin Social Support Scales (BSSS), Subscale 3
Time Frame: Change from baseline on BSSS, Subscale 3 (6 months)
The BSSS Subscale 3 measures social support seeking. Instruction and rating scale ware adapted to refer to social support self-efficacy. It consists of 5 items with response scale ranging from 1 to 7. Higher total score represents higher social support self-efficacy.
Change from baseline on BSSS, Subscale 3 (6 months)
Change on Berlin Social Support Scales (BSSS), Subscale 3
Time Frame: Change from baseline on BSSS, Subscale 3 (12 months)
The BSSS Subscale 3 measures social support seeking. Instruction and rating scale ware adapted to refer to social support self-efficacy. It consists of 5 items with response scale ranging from 1 to 7. Higher total score represents higher social support self-efficacy.
Change from baseline on BSSS, Subscale 3 (12 months)
Change on Who Can You Count On Scale
Time Frame: Change from baseline on Who Can You Count On Scale (3 or 6 weeks depending on the study condition)
The scale measures perceived social support. It consists of 32 items with response scale ranging from 1 to 5. The questionnaire consists of 4 subscales: support form supervisors, support from friends, support from family, friends. To compute total score subscales are summed. Higher total score represents higher perceived social support.
Change from baseline on Who Can You Count On Scale (3 or 6 weeks depending on the study condition)
Change on Who Can You Count On Scale
Time Frame: Change from baseline on Who Can You Count On Scale (6 months)
The scale measures perceived social support. It consists of 32 items with response scale ranging from 1 to 5. The questionnaire consists of 4 subscales: support form supervisors, support from friends, support from family, friends. To compute total score subscales are summed. Higher total score represents higher perceived social support.
Change from baseline on Who Can You Count On Scale (6 months)
Change on Who Can You Count On Scale
Time Frame: Change from baseline on Who Can You Count On Scale (12 months)
The scale measures perceived social support. It consists of 32 items with response scale ranging from 1 to 5. The questionnaire consists of 4 subscales: support form supervisors, support from friends, support from family, friends. To compute total score subscales are summed. Higher total score represents higher perceived social support.
Change from baseline on Who Can You Count On Scale (12 months)
Secondary Trauma Exposure Scale (STES)
Time Frame: Baseline
The STES measures job-related indirect exposure to traumatic events. It consists of 12 items with response scale for 10 items ranging from 0 to 1 and for remaining 2 items from 0 to 7. Higher total score represents higher secondary trauma exposure.
Baseline
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline
The CEQ measures expectancy and credibility of the intervention. It consists of 6 items, with response scale for 4 items ranging from 1 to 9, and for remaining 2 items from 0% to 100%. Higher total score represents higher treatment credibility and user's expectancy for improvement.
Baseline

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ewelina Smoktunowicz, PhD, SWSP University of Social Sciences and Humanities, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 8, 2018

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 22, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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