Internet-Based Intervention for Occupational Stress Among Medical Professionals

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Psychological, Occupational, Burnout, Professional

Intervention / Treatment
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* Behavioral: Personal resources' enhancement: self-efficacy and perceived social support
* Behavioral: Personal resources' enhancement: perceived social support and self-efficacy
* Behavioral: Personal resources' enhancement: self-efficacy
* Behavioral: Personal resources' enhancement: perceived social support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years Professionally active medical providers Internet connection Exclusion Criteria: No access to a device with Internet connection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Efficacy and Perceived Social Support<br> | Behavioral: Personal resources' enhancement: self-efficacy and perceived social support<br>* 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.<br>|
| Experimental: Perceived Social Support and Self-Efficacy<br> | Behavioral: Personal resources' enhancement: perceived social support and self-efficacy<br>* 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.<br>|
| Active Comparator: Self-Efficacy<br> | Behavioral: Personal resources' enhancement: self-efficacy<br>* 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.<br>|
| Active Comparator: Perceived Social Support<br> | Behavioral: Personal resources' enhancement: perceived social support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-mental health, stress, burnout, self-efficacy, social support