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The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector (ReTA-model)

Primary Purpose

Burnout

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ReTA-model
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout focused on measuring Healthcare, Burnout, Stress, Return to work, Intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • currently on sick leave for burnout
  • employed in the Swedish healthcare services as a nurse or as a physician

Exclusion Criteria:

-

Sites / Locations

  • Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Controll

Arm Description

Will receive a rehabilitation intervention

Will receive conventional rehabilitation

Outcomes

Primary Outcome Measures

Return to work
At work part or full-time compare to no return to work
Karolinska Exhaustion Disorder Scale KEDS
Decreased points in the KEDS scale 1-19, qith higher scores reflecting greater exhaustion severity.
Symptom Checklist - 6
Decreased points on the SCL-6 scale, with a higher number reflecting depression.
Montgomery Åsberg Depression Rating Scale
Decreased points in the MADRAS scale with score ranging from 0 to 60, with higher scores reflecting greater depression severity.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
March 30, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05314530
Brief Title
The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector
Acronym
ReTA-model
Official Title
Validation of the ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

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

5. Study Description

Brief Summary
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.
Detailed Description
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout
Keywords
Healthcare, Burnout, Stress, Return to work, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Will receive a rehabilitation intervention
Arm Title
Controll
Arm Type
Active Comparator
Arm Description
Will receive conventional rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
ReTA-model
Intervention Description
Validating the rehabilitation model ReTA
Primary Outcome Measure Information:
Title
Return to work
Description
At work part or full-time compare to no return to work
Time Frame
12 months
Title
Karolinska Exhaustion Disorder Scale KEDS
Description
Decreased points in the KEDS scale 1-19, qith higher scores reflecting greater exhaustion severity.
Time Frame
12 months
Title
Symptom Checklist - 6
Description
Decreased points on the SCL-6 scale, with a higher number reflecting depression.
Time Frame
12 months
Title
Montgomery Åsberg Depression Rating Scale
Description
Decreased points in the MADRAS scale with score ranging from 0 to 60, with higher scores reflecting greater depression severity.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: currently on sick leave for burnout employed in the Swedish healthcare services as a nurse or as a physician Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Hagqvist, PhD
Phone
+46730526602
Email
emma.hagqvist@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Åke Nygren, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Hagqvist
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Outside U.S. And Canada
ZIP/Postal Code
171 77
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Hagqvist, Phd
Phone
+46730526602
Email
emma.hagqvist@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector

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