Stress, Psychological, OccupationalMed-StressNCT03475290
Internet-Based Intervention for Occupational Stress Among Medical Professionals
A study testing Personal resources' enhancement: self-efficacy and perceived social support, Personal resources' enhancement: perceived social support and self-efficacy and Personal resources' enhancement: self-efficacy in people with Stress, Psychological, Occupational and Burnout, Professional, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Occupational, Burnout, Professional
- What is being tested?
- Personal resources' enhancement: self-efficacy and perceived social support, Personal resources' enhancement: perceived social support and self-efficacy and Personal resources' enhancement: self-efficacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 1 sitePoland
- Study dates
- 8 Oct 2018to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of at least 18 years
- Professionally active medical providers
- Internet connection
Who cannot join
- No access to a device with Internet connection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial
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.
- Being tested
- Personal resources' enhancement: self-efficacy and perceived social support, Personal resources' enhancement: perceived social support and self-efficacy, Personal resources' enhancement: self-efficacy, Personal resources' enhancement: perceived social support
- Keywords
- e-mental health, stress, burnout, self-efficacy, social support
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal resources' enhancement: self-efficacy and perceived social supportBehavioural
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-efficacyBehavioural
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-efficacyBehavioural
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 supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Efficacy and Perceived Social Support | Experimental | Not described Receives: Behavioral: Personal resources' enhancement: self-efficacy and perceived social support |
| Perceived Social Support and Self-Efficacy | Experimental | Not described Receives: Behavioral: Personal resources' enhancement: perceived social support and self-efficacy |
| Self-Efficacy | Active comparator | Not described Receives: Behavioral: Personal resources' enhancement: self-efficacy |
| Perceived Social Support | Active comparator | Not described Receives: Behavioral: Personal resources' enhancement: perceived social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline on OLBI (12 months)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline on PCL-5 (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start8 Oct 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Stress, Psychological, OccupationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Stockholm University
- Responsible party
- Principal investigator, Ewelina Smoktunowicz, University of Social Sciences and Humanities, Warsaw
- Investigators
- Ewelina Smoktunowicz, PhD, Principal investigator, SWSP University of Social Sciences and Humanities, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475290
- Sponsor's protocol ID
- I.N.16 Med-Stress
- Acronym
- Med-Stress
- Status last verified
- Nov 2020
- First submitted
- 28 Feb 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15350854Cieslak 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 24177477Widerszal-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 10828153Cohen 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 6668417Demerouti 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 20604629Devilly 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 11132119Kroenke 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 11556941Lua 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 33427674Smoktunowicz 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Internet-Based Intervention for Occupational Stress Among Medical Professionals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03475290
- Acronym / sponsor ID
- Med-Stress / I.N.16 Med-Stress
- Keywords
- e-mental health, stress, burnout, self-efficacy, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,240 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- Linkoeping University, Stockholm University
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of at least 18 years
- Professionally active medical providers
- Internet connection
Key exclusion criteria (1 listed)
- No access to a device with Internet connection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal resources' enhancement: self-efficacy and perceived social supportThe 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. | Behavioural | Self-Efficacy and Perceived Social Support |
| Personal resources' enhancement: perceived social support and self-efficacyThe 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. | Behavioural | Perceived Social Support and Self-Efficacy |
| Personal resources' enhancement: self-efficacyThe 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. | Behavioural | Self-Efficacy |
| Personal resources' enhancement: perceived social supportThe 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. | Behavioural | Perceived Social Support |
Primary outcome
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.
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.
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.
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.
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.
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.
9 secondary outcomes
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)
Change on Utrecht Work Engagement Scale (UWES-3)
Time frame: Change from baseline on UWES-3 (6 months)
Change on Utrecht Work Engagement Scale (UWES-3)
Time frame: Change from baseline on UWES-3 (12 months)
Change on Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline on PHQ-9 (3 or 6 weeks depending on the study condition)
Change on Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline on PHQ-9 (6 months)
Change on Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline on PHQ-9 (12 months)
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)
Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: Change from baseline on PCL-5 (6 months)
Change on Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: Change from baseline on PCL-5 (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 15350854Benight 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.
- Background: PubMed 24177477Cieslak 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.
- Background: PubMed 10828153Widerszal-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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 20604629Demerouti 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.
- Background: PubMed 11132119Devilly 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.
- Background: PubMed 11556941Kroenke 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.
- BackgroundLua 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.
- BackgroundSchaufeli, 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.
- BackgroundSchwarzer, 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
- BackgroundSchwarzer R, Schulz U (2000) Berlin Social Support Scale (BSSS). Retrieved from http://userpage.fu-berlin.de/~health/bsss.htm
- BackgroundWeathers, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewelina Smoktunowicz, PhD principal investigator
SWSP University of Social Sciences and Humanities, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal resources' enhancement: self-efficacy and perceived social support, Personal resources' enhancement: perceived social support and self-efficacy and Personal resources' enhancement: self-efficacy in people with Stress, Psychological, Occupational and Burnout, Professional, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475290, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.