Internet-Based Intervention for Occupational Stress Among Medical Professionals

Burnout, Professional Clinical Trial

— Med-Stress  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475290
• Other study ID #: I.N.16 Med-Stress
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: November 2020
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1240
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of at least 18 years

• Professionally active medical providers

• Internet connection

Exclusion Criteria:

• No access to a device with Internet connection

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Occupational Stress
• Stress, Psychological
• Stress, Psychological, Occupational

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Poland	SWPS University of Social Sciences and Humanities	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw	Linkoeping University, Stockholm University

Country where clinical trial is conducted

Poland, 

References & Publications (12)

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. — View 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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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. — View Citation

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View 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. — View 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.

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, Schulz U (2000) Berlin Social Support Scale (BSSS). Retrieved from http://userpage.fu-berlin.de/~health/bsss.htm

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

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.

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)	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)
Other	Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)	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)
Other	Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)	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)
Other	Change on Berlin Social Support Scales (BSSS), Subscale 3	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)
Other	Change on Berlin Social Support Scales (BSSS), Subscale 3	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)
Other	Change on Berlin Social Support Scales (BSSS), Subscale 3	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)
Other	Change on Who Can You Count On Scale	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)
Other	Change on Who Can You Count On Scale	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)
Other	Change on Who Can You Count On Scale	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)
Other	Secondary Trauma Exposure Scale (STES)	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
Other	Credibility and Expectancy Questionnaire (CEQ)	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
Primary	Change on Perceived Stress Scale 14 (PSS-14)	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)
Primary	Change on Perceived Stress Scale 14 (PSS-14)	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)
Primary	Change on Perceived Stress Scale 14 (PSS-14)	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)
Primary	Change on Oldenburg Burnout Inventory (OLBI)	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)
Primary	Change on Oldenburg Burnout Inventory (OLBI)	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)
Primary	Change on Oldenburg Burnout Inventory (OLBI)	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	Change on Utrecht Work Engagement Scale (UWES-3)	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)
Secondary	Change on Utrecht Work Engagement Scale (UWES-3)	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)
Secondary	Change on Utrecht Work Engagement Scale (UWES-3)	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)
Secondary	Change on Patient Health Questionnaire (PHQ-9)	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)
Secondary	Change on Patient Health Questionnaire (PHQ-9)	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)
Secondary	Change on Patient Health Questionnaire (PHQ-9)	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)
Secondary	Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)	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)
Secondary	Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)	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)
Secondary	Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)	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)