NCT05343208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 1916

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 1916

Completed
104.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

104.4 years

First QC Date

April 14, 2022

Last Update Submit

April 22, 2022

Conditions

Keywords

PreventionMental HealthCognitive Behavioral TherapyInteractive Online TherapyTeleHealth

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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.

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.

Interventions

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.

Cognitive Behavioral Therapy Group

Eligibility Criteria

Age22 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Employees assessed on the EFP Burnout Scale as having:
  • No evidence of Burnout
  • Low Risk of Burnout.
  • Unemployed persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SciensCollege

Malmo, Skåne County, 21124, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, PsychologicalRisk Reduction BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Clive S Michelsen, M.Sc.

    SciensCollege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Randomly selected from an employer list
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 25, 2022

Study Start

September 5, 1916

Primary Completion

January 11, 2021

Study Completion

April 4, 2022

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication. SPSS files.

Shared Documents
SAP
Time Frame
The data is available from April 15, 2022 for one year until April 14th, 2023
Access Criteria
contact clive@scienscollege.se with your reason for this research and your contact details. You'll be forwarded the SPSS data file.

Locations