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CompletedNCT03475290Med-StressUpdated Nov 4, 2020

Internet-Based Intervention for Occupational Stress Among Medical Professionals

An interventional study of Personal resources' enhancement: self-efficacy and perceived social support and Personal resources' enhancement: perceived social support and self-efficacy in Stress, Psychological, Occupational and Burnout, Professional, sponsored by University of Social Sciences and Humanities, Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by University of Social Sciences and Humanities, Warsaw · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress, Psychological, Occupational
  • Burnout, Professional

Keywords

  • e-mental health
  • stress
  • burnout
  • self-efficacy
  • social support
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No access to a device with Internet connection
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,240 participants (actual)

Study arms

  • Experimental
    Self-Efficacy and Perceived Social Support

    Behavioral: Personal resources' enhancement: self-efficacy and perceived social support

  • Experimental
    Perceived Social Support and Self-Efficacy

    Behavioral: Personal resources' enhancement: perceived social support and self-efficacy

  • Active comparator
    Self-Efficacy

    Behavioral: Personal resources' enhancement: self-efficacy

  • Active comparator
    Perceived Social Support

    Behavioral: Personal resources' enhancement: perceived social support

Interventions

  • BehavioralPersonal 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.

  • BehavioralPersonal 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.

  • BehavioralPersonal 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.

  • BehavioralPersonal 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline on PSS-14 (3 or 6 weeks depending on the study condition)

  2. 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.

    Time frame: Change from baseline on PSS-14 (6 months)

  3. 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.

    Time frame: Change from baseline on PSS-14 (12 months)

  4. 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.

    Time frame: Change from baseline on OLBI (3 or 6 weeks depending on the study condition)

  5. 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.

    Time frame: Change from baseline on OLBI (6 months)

  6. 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.

    Time frame: Change from baseline on OLBI (12 months)

Secondary outcomes

  1. 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.

    Time frame: Change from baseline on UWES-3 (3 or 6 weeks depending on the study condition)

  2. 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.

    Time frame: Change from baseline on UWES-3 (6 months)

  3. 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.

    Time frame: Change from baseline on UWES-3 (12 months)

  4. 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.

    Time frame: Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)

  5. 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.

    Time frame: Change from baseline on PHQ-9 (6 months)

  6. 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.

    Time frame: Change from baseline on PHQ-9 (12 months)

  7. 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.

    Time frame: Change from baseline on PCL-5 (3 or 6 weeks depending on the study condition)

  8. 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.

    Time frame: Change from baseline on PCL-5 (6 months)

  9. 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.

    Time frame: Change from baseline on PCL-5 (12 months)

Other outcomes

  1. 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.

    Time frame: Change from baseline on WSBSES (3 or 6 weeks depending on the study condition)

  2. 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.

    Time frame: Change from baseline on WSBSES (6 months)

  3. 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.

    Time frame: Change from baseline on WSBSES (12 months)

  4. 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.

    Time frame: Change from baseline on BSSS, Subscale 3 (3 or 6 weeks depending on the study condition)

  5. 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.

    Time frame: Change from baseline on BSSS, Subscale 3 (6 months)

  6. 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.

    Time frame: Change from baseline on BSSS, Subscale 3 (12 months)

  7. 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.

    Time frame: Change from baseline on Who Can You Count On Scale (3 or 6 weeks depending on the study condition)

  8. 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.

    Time frame: Change from baseline on Who Can You Count On Scale (6 months)

  9. 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.

    Time frame: Change from baseline on Who Can You Count On Scale (12 months)

  10. 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.

    Time frame: Baseline

  11. 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.

    Time frame: Baseline

06

Study locations

1 site
  • SWPS University of Social Sciences and Humanities
    Warsaw, 00-864, Poland
07

References and documents

Publications

  • 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. PubMed 15350854 ↗
  • 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. PubMed 24177477 ↗
  • 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. PubMed 10828153 ↗
  • 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. PubMed 6668417 ↗
  • 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. PubMed 20604629 ↗
  • 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. PubMed 11132119 ↗
  • 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. PubMed 11556941 ↗
  • 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
  • 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.
  • 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. PubMed 33427674 ↗
  • 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. PubMed 31182128 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03475290
Lead sponsor
University of Social Sciences and Humanities, Warsaw
Collaborators
Linkoeping University, Stockholm University
Responsible party
Ewelina Smoktunowicz (Principal Investigator, University of Social Sciences and Humanities, Warsaw) — Principal investigator
First posted
Mar 23, 2018
Start date
Oct 8, 2018
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020
Last update
Nov 4, 2020

Study contacts

Ewelina Smoktunowicz, PhD
principal investigator · SWSP University of Social Sciences and Humanities, Department of Psychology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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