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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Poland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self-Efficacy and Perceived Social Support
Behavioral: Personal resources' enhancement: 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
Behavioral: Personal resources' enhancement: 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
Behavioral: Personal resources' enhancement: 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
Behavioral: Personal resources' enhancement: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Social Sciences and Humanities, Warsaw

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Stockholm University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I.N.16 Med-Stress

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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