Clinical trial NCT03475290: Internet-Based Intervention for Occupational Stress Among Medical Professionals
Official title: Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological, Occupational
Burnout, Professional
Keywords: e-mental health
stress
burnout
self-efficacy
social support
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Stockholm University
First posted: 2018-03-23
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No access to a device with Internet connection

Primary outcomes:
measure: Change on Perceived Stress Scale 14 (PSS-14)
timeFrame: Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)
measure: Change on Perceived Stress Scale 14 (PSS-14)
timeFrame: Change from baseline on PSS-14 (6 months)
measure: Change on Perceived Stress Scale 14 (PSS-14)
timeFrame: Change from baseline on PSS-14 (12 months)
measure: Change on Oldenburg Burnout Inventory (OLBI)
timeFrame: Change from baseline on OLBI (3 or 6 weeks depending on the study condition)
measure: Change on Oldenburg Burnout Inventory (OLBI)
timeFrame: Change from baseline on OLBI (6 months)
measure: Change on Oldenburg Burnout Inventory (OLBI)
timeFrame: Change from baseline on OLBI (12 months)
Secondary outcomes:
measure: Change on Utrecht Work Engagement Scale (UWES-3)
timeFrame: Change from baseline on UWES-3 (3 or 6 weeks depending on the study condition)
measure: Change on Utrecht Work Engagement Scale (UWES-3)
timeFrame: Change from baseline on UWES-3 (6 months)
measure: Change on Utrecht Work Engagement Scale (UWES-3)
timeFrame: Change from baseline on UWES-3 (12 months)
measure: Change on Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)
measure: Change on Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline on PHQ-9 (6 months)
measure: Change on Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline on PHQ-9 (12 months)
measure: Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Change from baseline on PCL-5 (3 or 6 weeks depending on the study condition)
measure: Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Change from baseline on PCL-5 (6 months)
measure: Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Change from baseline on PCL-5 (12 months)
Other outcomes:
measure: Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
timeFrame: Change from baseline on WSBSES (3 or 6 weeks depending on the study condition)
measure: Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
timeFrame: Change from baseline on WSBSES (6 months)
measure: Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)
timeFrame: Change from baseline on WSBSES (12 months)
measure: Change on Berlin Social Support Scales (BSSS), Subscale 3
timeFrame: Change from baseline on BSSS, Subscale 3 (3 or 6 weeks depending on the study condition)
measure: Change on Berlin Social Support Scales (BSSS), Subscale 3
timeFrame: Change from baseline on BSSS, Subscale 3 (6 months)
measure: Change on Berlin Social Support Scales (BSSS), Subscale 3
timeFrame: Change from baseline on BSSS, Subscale 3 (12 months)
measure: Change on Who Can You Count On Scale
timeFrame: Change from baseline on Who Can You Count On Scale (3 or 6 weeks depending on the study condition)
measure: Change on Who Can You Count On Scale
timeFrame: Change from baseline on Who Can You Count On Scale (6 months)
measure: Change on Who Can You Count On Scale
timeFrame: Change from baseline on Who Can You Count On Scale (12 months)
measure: Secondary Trauma Exposure Scale (STES)
timeFrame: Baseline
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline
Locations:
city: Warsaw
country: Poland
facility: SWPS University of Social Sciences and Humanities
Study officials:
affiliation: SWSP University of Social Sciences and Humanities, Department of Psychology
name: Ewelina Smoktunowicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Schwarzer R, Schulz U (2000) Berlin Social Support Scale (BSSS). Retrieved from http://userpage.fu-berlin.de/~health/bsss.htm
citation: 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.
citation: 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.
citation: 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.