NCT03475290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

February 28, 2018

Last Update Submit

November 3, 2020

Conditions

Keywords

e-mental healthstressburnoutself-efficacysocial support

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (9)

  • Change on Utrecht Work Engagement Scale (UWES-3)

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

  • Change on Utrecht Work Engagement Scale (UWES-3)

    Change from baseline on UWES-3 (6 months)

  • Change on Utrecht Work Engagement Scale (UWES-3)

    Change from baseline on UWES-3 (12 months)

  • Change on Patient Health Questionnaire (PHQ-9)

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

  • Change on Patient Health Questionnaire (PHQ-9)

    Change from baseline on PHQ-9 (6 months)

  • +4 more secondary outcomes

Other Outcomes (11)

  • Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)

    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)

    Change from baseline on WSBSES (6 months)

  • Change on Work Stress and Job Burnout Self-Efficacy Scale (WSBSES)

    Change from baseline on WSBSES (12 months)

  • +8 more other outcomes

Study Arms (4)

Self-Efficacy and Perceived Social Support

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

Perceived Social Support and Self-Efficacy

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

Self-Efficacy

ACTIVE COMPARATOR
Behavioral: Personal resources' enhancement: self-efficacy

Perceived Social Support

ACTIVE COMPARATOR
Behavioral: Personal resources' enhancement: perceived social support

Interventions

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.

Self-Efficacy and Perceived Social Support

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.

Perceived Social Support and 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.

Self-Efficacy

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.

Perceived Social Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No access to a device with Internet connection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SWPS University of Social Sciences and Humanities

Warsaw, 00-864, Poland

Location

Related Publications (14)

  • 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.

    PMID: 15350854BACKGROUND
  • 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.

    PMID: 24177477BACKGROUND
  • 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.

    PMID: 10828153BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 20604629BACKGROUND
  • 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.

    PMID: 11132119BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Ewelina Smoktunowicz, PhD

    SWSP University of Social Sciences and Humanities, Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 23, 2018

Study Start

October 8, 2018

Primary Completion

April 15, 2020

Study Completion

April 15, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations