BurnoutNCT05343208
Effectiveness of Online Therapy to Prevent Burnout
A study testing EFP Psychometric assessment to determine level of afflication in people with Burnout and Risk Reduction, run by SciensCollege at 1 site in Sweden.
Trial summary
This study aims to address the reliability and validity of the Empowerment for Participation (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online interventions to provide proactive rehabilitation using Cognitive Behavioral Therapy (CBT) and floating to achieve improved mental health… Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Burnout, Risk Reduction, Cognitive Change
- What is being tested?
- EFP Psychometric assessment to determine level of afflication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 5 Sep 1916to 4 Apr 2022
- 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 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employees assessed on the EFP Burnout Scale as having:
- a Moderate Risk of Burnout
- a High Risk of Burnout
- A Burned out Risk (Mental Health Exhaustion)
- Employees with a current Bunrout diagnosis from a hospital, outpatient or psychiatric cllinic
- A fully employed person with a member organization
- No other inclusion criteria.
Who cannot join
- Employees assessed on the EFP Burnout Scale as having:
- No evidence of Burnout
- Low Risk of Burnout.
- Unemployed persons
- No other exclusion critera was used.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to address the reliability and validity of the Empowerment for Participation (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online interventions to provide proactive rehabilitation using Cognitive Behavioral Therapy (CBT) and floating to achieve improved mental health and wellbeing.
Read the detailed description
An Empirical design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group. The aim is to test whether or not there is a statistically significant difference in the effectiveness on online therapy to reduce the Risk for Burnout compared to that of a Control Group. Fifty participants were randomly selected. The rehabilitation and control Group consisted of twenty-five normally distributed employees (N25) each. The rehabilitation group received therapy, and the control had not yet received any form of therapy. SPSS was used to analyze the data collected, a Repeated Measure ANOVA, an ANCOVA, a Discriminant analysis, and a Construct Validity analysis were used to test for Reliability and Validity.
The group was randomly selected from a list of employees within the My-E-Health ecosystem. The group (N50) normally distributed group met all assumptions and consisted of a Control Group (N25) and a Therapy Group (N25). The post assessment value was used as the dependent variable.
The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP) batch of assessments (110 questions). All assessments and CBT were done digitally online and floating was done at a designated location. The full EFP assessment is integrated into a digital ecosystem designed for this purpose and therapy. The online digital system is an integrity-based platform offering both the employee and caregiver a secure and encrypted ecosystem or secure data tunnel or channel between the therapists and patients.
- Conditions
- Burnout, Risk Reduction, Cognitive Change
- Being tested
- EFP Psychometric assessment to determine level of afflication
- Keywords
- Prevention, Mental Health, Cognitive Behavioral Therapy, Interactive Online Therapy, TeleHealth
- Medical subject headings
- Burnout, Psychological, Risk Reduction Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFP Psychometric assessment to determine level of afflicationDiagnostic test
Patients were asked to complete a psychometric assessment in relation to their psychological wellbeing. Results were presented to the patient and validdated by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | The group received online Cognitive Behavioral Therapy via the My-E-Health. Patients were issued a preTest psychometric assessment and a post therapy assessment using the Burnout Psychometrics provided within the My-E-Health's online ecosystem. All patients were required to validate the accuracy of the assessments during a follow-up of their results. Receives: Diagnostic Test: EFP Psychometric assessment to determine level of afflication |
| Control Group | No intervention | The Control Group received no online therapy. Patients were issued a preTest psychometric assessment and a post therapy assessment using the Burnout Psychometrics provided within the My-E-Health's online ecosystem. All patients were required to validate the accuracy of the assessments during a follow-up of their results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the difference between a pre- and post-assessment score for Burnout in a Control Group versus a Therapy Group.
The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP) batch of assessments using Visual Analog Scales (VAS) online. A straight line with a beginning and end point. As the slider moves from left to right, the text positioned at either end of the line increases as the opposite end decreases. The position where the slider stops is represented by a number from 0-20.
The risk assessment scale (0-600) determines the level of intervention and preventive care.
There are five risk levels of Burnout in relation to the total score following a lineal guide: 0-99 points (M=0-3.300) = No evidence of Burnout, 100-199 points (M=3.333-6.6333) = Low risk for Burnout, 200-299 points (M=6.6667-9.9667) = Moderate risk for Burnout, 300-399 points (M=10.00-13.300) = High risk for Burnout, and 400-600 points (M=13.3333-20) = Burnout. Patient content validation and score accuracy is required after each assessment.
Measured: From admission to discharge, up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start5 Sep 1916
- Primary completion11 Jan 2021
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An empirical and parallel design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciensCollege
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karlstad University, My-E-Health UK LImited
- Responsible party
- Sponsor
- Investigators
- Clive S Michelsen, M.Sc., Principal investigator, SciensCollege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343208
- Sponsor's protocol ID
- SC-EOTPB-1
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication. SPSS files.
Publications
Michelsen C, Kjellgren A. The Effectiveness of Web-Based Psychotherapy to Treat and Prevent Burnout: Controlled Trial. JMIR Form Res. 2022 Aug 11;6(8):e39129. doi: 10.2196/39129.
PubMed 35802001
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Therapy to Prevent Burnout
- ClinicalTrials.gov ID
- NCT05343208
- Acronym / sponsor ID
- SC-EOTPB-1
- Conditions
- Burnout, Risk Reduction, Cognitive Change
- Keywords
- Prevention, Mental Health, Cognitive Behavioral Therapy, Interactive Online Therapy, TeleHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SciensCollegeIndustry (pharma, biotech, devices)
- Collaborators
- Karlstad University, My-E-Health UK LImited
- Study start
- 5 Sep 1916 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 25 Apr 2022 (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.
This study aims to address the reliability and validity of the Empowerment for Participation (EFP) batch of assessments to measure Burnout risk in relation to the efficacy of online interventions to provide proactive rehabilitation using Cognitive Behavioral Therapy (CBT) and floating to achieve improved mental health and wellbeing.
Detailed description
An Empirical design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group. The aim is to test whether or not there is a statistically significant difference in the effectiveness on online therapy to reduce the Risk for Burnout compared to that of a Control Group. Fifty participants were randomly selected. The rehabilitation and control Group consisted of twenty-five normally distributed employees (N25) each. The rehabilitation group received therapy, and the control had not yet received any form of therapy. SPSS was used to analyze the data collected, a Repeated Measure ANOVA, an ANCOVA, a Discriminant analysis, and a Construct Validity analysis were used to test for Reliability and Validity.
The group was randomly selected from a list of employees within the My-E-Health ecosystem. The group (N50) normally distributed group met all assumptions and consisted of a Control Group (N25) and a Therapy Group (N25). The post assessment value was used as the dependent variable.
The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP) batch of assessments (110 questions). All assessments and CBT were done digitally online and floating was done at a designated location. The full EFP assessment is integrated into a digital ecosystem designed for this purpose and therapy. The online digital system is an integrity-based platform offering both the employee and caregiver a secure and encrypted ecosystem or secure data tunnel or channel between the therapists and patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An empirical and parallel design using raw EFP psychometric data to measure the effectiveness of online therapy to reduce the risk for Burnout between a control group and an online therapy group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Group | Experimental | Diagnostic Test: EFP Psychometric assessment to determine level of afflicationThe group received online Cognitive Behavioral Therapy via the My-E-Health. Patients were issued a preTest psychometric assessment and a post therapy assessment using the Burnout Psychometrics provided within the My-E-Health's online ecosystem. All patients were required to validate the accuracy of the assessments during a follow-up of their results. |
| Control Group | No intervention | –The Control Group received no online therapy. Patients were issued a preTest psychometric assessment and a post therapy assessment using the Burnout Psychometrics provided within the My-E-Health's online ecosystem. All patients were required to validate the accuracy of the assessments during a follow-up of their results. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a Moderate Risk of Burnout
- a High Risk of Burnout
- A Burned out Risk (Mental Health Exhaustion)
- Employees with a current Bunrout diagnosis from a hospital, outpatient or psychiatric cllinic
- A fully employed person with a member organization
Key exclusion criteria (5 listed)
- No evidence of Burnout
- Low Risk of Burnout.
- Unemployed persons
- No other exclusion critera was used.
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 |
|---|---|---|
| EFP Psychometric assessment to determine level of afflicationPatients were asked to complete a psychometric assessment in relation to their psychological wellbeing. Results were presented to the patient and validdated by the patient. | Diagnostic test | Cognitive Behavioral Therapy Group |
Primary outcome
To measure the difference between a pre- and post-assessment score for Burnout in a Control Group versus a Therapy Group.
Time frame: From admission to discharge, up to 3 months.
The Burnout measure (30 questions) is obtained from the Empowerment for Participation (EFP) batch of assessments using Visual Analog Scales (VAS) online. A straight line with a beginning and end point. As the slider moves from left to right, the text positioned at either end of the line increases as the opposite end decreases. The position where the slider stops is represented by a number from 0-20. The risk assessment scale (0-600) determines the level of intervention and preventive care. There are five risk levels of Burnout in relation to the total score following a lineal guide: 0-99 points (M=0-3.300) = No evidence of Burnout, 100-199 points (M=3.333-6.6333) = Low risk for Burnout, 200-299 points (M=6.6667-9.9667) = Moderate risk for Burnout, 300-399 points (M=10.00-13.300) = High risk for Burnout, and 400-600 points (M=13.3333-20) = Burnout. Patient content validation and score accuracy is required after each assessment.
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 25 Apr 2022.
- Derived from this study: PubMed 35802001Michelsen C, Kjellgren A. The Effectiveness of Web-Based Psychotherapy to Treat and Prevent Burnout: Controlled Trial. JMIR Form Res. 2022 Aug 11;6(8):e39129. doi: 10.2196/39129.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication. SPSS files.
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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.
Clive S Michelsen, M.Sc. principal investigator
SciensCollege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFP Psychometric assessment to determine level of afflication in people with Burnout and Risk Reduction, run by SciensCollege at 1 site in Sweden.
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 7 inclusion and 5 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 25 Apr 2022. 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 Sweden. 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?
To measure the difference between a pre- and post-assessment score for Burnout in a Control Group versus a Therapy Group. (time frame: From admission to discharge, up to 3 months.). 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 NCT05343208, which also lists 1 linked publication.
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 25 Apr 2022.