- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343208
Effectiveness of Online Therapy to Prevent Burnout
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Skåne
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Malmö, Skåne, Sweden, 21124
- SciensCollege
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Behavioral Therapy Group
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.
|
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.
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No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
From admission to discharge, up to 3 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clive S Michelsen, M.Sc., SciensCollege
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-EOTPB-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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