- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475290
Internet-Based Intervention for Occupational Stress Among Medical Professionals (Med-Stress)
Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
- Behavioral: Personal resources' enhancement: self-efficacy and perceived social support
- Behavioral: Personal resources' enhancement: perceived social support and self-efficacy
- Behavioral: Personal resources' enhancement: self-efficacy
- Behavioral: Personal resources' enhancement: perceived social support
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Warsaw, Poland, 00-864
- SWPS University of Social Sciences and Humanities
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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Experimental: Self-Efficacy and Perceived Social Support
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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.
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Experimental: Perceived Social Support and Self-Efficacy
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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.
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Active Comparator: Self-Efficacy
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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
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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.
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Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)
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|
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)
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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)
|
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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.
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Change from baseline on OLBI (3 or 6 weeks depending on the study condition)
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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.
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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)
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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.
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Change from baseline on UWES-3 (3 or 6 weeks depending on the study condition)
|
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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)
|
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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.
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Change from baseline on UWES-3 (12 months)
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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.
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Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)
|
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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.
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Change from baseline on PHQ-9 (6 months)
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|
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.
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Change from baseline on PHQ-9 (12 months)
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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.
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Change from baseline on PCL-5 (3 or 6 weeks depending on the study condition)
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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.
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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.
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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.
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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.
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Change from baseline on WSBSES (12 months)
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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)
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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.
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Change from baseline on BSSS, Subscale 3 (3 or 6 weeks depending on the study condition)
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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.
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Change from baseline on BSSS, Subscale 3 (6 months)
|
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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.
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Change from baseline on BSSS, Subscale 3 (12 months)
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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)
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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.
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Change from baseline on Who Can You Count On Scale (3 or 6 weeks depending on the study condition)
|
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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
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Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Ewelina Smoktunowicz, PhD, SWSP University of Social Sciences and Humanities, Department of Psychology
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
- Benight CC, Bandura A. Social cognitive theory of posttraumatic recovery: the role of perceived self-efficacy. Behav Res Ther. 2004 Oct;42(10):1129-48. doi: 10.1016/j.brat.2003.08.008.
- Cieslak R, Anderson V, Bock J, Moore BA, Peterson AL, Benight CC. Secondary traumatic stress among mental health providers working with the military: prevalence and its work- and exposure-related correlates. J Nerv Ment Dis. 2013 Nov;201(11):917-25. doi: 10.1097/NMD.0000000000000034.
- Widerszal-Bazyl M, Cieslak R. Monitoring psychosocial stress at work: development of the Psychosocial Working Conditions Questionnaire. Int J Occup Saf Ergon. 2000;Spec No:59-70. doi: 10.1080/10803548.2000.11105108.
- Demerouti E, Mostert K, Bakker AB. Burnout and work engagement: a thorough investigation of the independency of both constructs. J Occup Health Psychol. 2010 Jul;15(3):209-222. doi: 10.1037/a0019408.
- Lua H.J. The mediating role of work stress and burnout management self-efficacy in the job demand - resources model [dissertation]. SWPS University of Social Sciences and Humanities, Warsaw 2008.
- Schaufeli, W.B., Shimazu, A., Hakanen, J., Salanova, M., & De Witte, H. (2017). An ultra-short measure for work engagement: The UWES-3. Validation across five countries. European Journal of Psychological Assessment. Advance online publication. doi:10.1027/1015-5759/a000430.
- Schwarzer, R., & Knoll, N. (2007). Functional roles of social support within the stress and coping process: A theoretical and empirical overview. International journal of psychology, 42(4), 243-252. doi: 10.1080/00207590701396641
- Schwarzer R, Schulz U (2000) Berlin Social Support Scale (BSSS). Retrieved from http://userpage.fu-berlin.de/~health/bsss.htm
- Smoktunowicz E, Lesnierowska M, Carlbring P, Andersson G, Cieslak R. Resource-Based Internet Intervention (Med-Stress) to Improve Well-Being Among Medical Professionals: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 11;23(1):e21445. doi: 10.2196/21445.
- Smoktunowicz E, Lesnierowska M, Cieslak R, Carlbring P, Andersson G. Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial. Trials. 2019 Jun 10;20(1):338. doi: 10.1186/s13063-019-3401-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I.N.16 Med-Stress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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