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Completed

NCT Number: NCT03475290

Internet-Based Intervention for Occupational Stress Among Medical Professionals

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.

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Key information

Conditions

Stress, Psychological, Occupational Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological Occupational Diseases Occupational Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SWPS University of Social Sciences and Humanities

Warsaw, 00-864, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No access to a device with Internet connection

Treatment and study plan

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

    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.

  5. 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.

  6. 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.

  7. 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)

    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.

  8. 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.

  9. 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.

  10. 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.

  11. Credibility and Expectancy Questionnaire (CEQ)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Social Sciences and Humanities, Warsaw

Other

Collaborators

  • Linkoeping University
  • Stockholm University

Registry information

Official study title

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

Acronym: Med-Stress

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2018
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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