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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05343208
Other study ID # SC-EOTPB-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 1916
Est. completion date April 4, 2022

Study information

Verified date April 2022
Source SciensCollege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 and wellbeing.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 4, 2022
Est. primary completion date January 11, 2021
Accepts healthy volunteers No
Gender All
Age group 22 Years to 68 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
EFP Psychometric assessment to determine level of afflication
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.

Locations

Country Name City State
Sweden SciensCollege Malmö Skåne

Sponsors (3)

Lead Sponsor Collaborator
SciensCollege Karlstad University, My-E-Health

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
From admission to discharge, up to 3 months.
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