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Effectiveness of Online Therapy to Prevent Burnout

Primary Purpose

Burnout, Risk Reduction, Cognitive Change

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
EFP Psychometric assessment to determine level of afflication
Sponsored by
SciensCollege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout focused on measuring Prevention, Mental Health, Cognitive Behavioral Therapy, Interactive Online Therapy, TeleHealth

Eligibility Criteria

22 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SciensCollege

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
April 22, 2022
Sponsor
SciensCollege
Collaborators
Karlstad University, My-E-Health
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1. Study Identification

Unique Protocol Identification Number
NCT05343208
Brief Title
Effectiveness of Online Therapy to Prevent Burnout
Official Title
Effectiveness of Online Therapy to Prevent Burnout
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 1916 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciensCollege
Collaborators
Karlstad University, My-E-Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Risk Reduction, Cognitive Change
Keywords
Prevention, Mental Health, Cognitive Behavioral Therapy, Interactive Online Therapy, TeleHealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Randomly selected from an employer list
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
EFP Psychometric assessment to determine level of afflication
Intervention Description
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.
Primary Outcome Measure Information:
Title
To measure the difference between a pre- and post-assessment score for Burnout in a Control Group versus a Therapy Group.
Description
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.
Time Frame
From admission to discharge, up to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clive S Michelsen, M.Sc.
Organizational Affiliation
SciensCollege
Official's Role
Principal Investigator
Facility Information:
Facility Name
SciensCollege
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21124
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication. SPSS files.
IPD Sharing Time Frame
The data is available from April 15, 2022 for one year until April 14th, 2023
IPD Sharing Access Criteria
contact clive@scienscollege.se with your reason for this research and your contact details. You'll be forwarded the SPSS data file.
Citations:
PubMed Identifier
35802001
Citation
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.
Results Reference
derived

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Effectiveness of Online Therapy to Prevent Burnout

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