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Outcome Study of the ReDO Intervention for Women With Stress-related Disorders

Primary Purpose

Adjustment Disorders, Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Redesigning Daily Occupations
Care as usual
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorders

Eligibility Criteria

20 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Adjustment disorder or Burnout
  • Being on sick-leave for > 2 months (full time or part time)
  • Having an employment

Exclusion Criteria:

  • Other main diagnosis than Adjustment disorder or Burnout

Sites / Locations

  • Halland County Concil primary health care services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Redesigning Daily Occupations

Care as usual

Arm Description

The ReDO intervention focuses on how people compose their everyday lives. Supporting people in how to change and modify their patterns of daily occupations is a new intervention method for people with stress-related disorders, but it has been shown to be effective in improving quality of life and self-rated health in other target groups. The basic idea is that re-structuring of an individual's lifestyle and pattern of daily occupations will lead to a healthier balance between the occupations of everyday life, and that this balance will promote wellness and improved work capacity. The program is group based and comprises 16 weeks, with sessions 2 x 2 hours per week, followed by 3-4 booster sessions.

Standard rehabilitation provided by the Social Insurance Office, such as stress management, physical therapy, mindfulness training.

Outcomes

Primary Outcome Measures

Return to work
Return to work

Secondary Outcome Measures

Perceived stress
Perceived stress

Full Information

First Posted
November 2, 2010
Last Updated
November 13, 2012
Sponsor
Lund University
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT01234961
Brief Title
Outcome Study of the ReDO Intervention for Women With Stress-related Disorders
Official Title
Outcomes of the Work Rehabilitation Method Redesigning Daily Occupations (ReDO) - a Quasi-experimental Study Among Women With Stress-related Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project evaluates the outcomes of a work rehabilitation program, Redesigning Daily Occupations (ReDO), for women with stress-related disorders. The ReDO intervention focuses on how people compose their everyday lives. The basic idea is that re-structuring of an individual's lifestyle and pattern of daily occupations will lead to a healthier balance between the occupations of everyday life, and that this balance will promote wellness and increased work capacity. The program is group based and comprises 16 weeks. The aim is to evaluate ReDO for women with stress-related disorders. The project, which covers the time period from entering the program to a 12-month follow-up, is a quasi-experimental study. 42 women who entered the program and fitted the selection criteria were included. A matched comparison group was selected among those clients at the Social Insurance Office who get "care-as-usual" (CAU). Both groups are followed prospectively and are compared regarding return to work, sick leave, and different aspects of health and well-being. The hypothesis is that the ReDO group will improve more than the CAU group in all these respects.
Detailed Description
This project is about developing and evaluating a novel work rehabilitation program, Redesigning Daily Occupations (ReDO), for women with stress-related disorders. It is a co-operation project between Lund University, the Social Insurance Office, and the health care services of the County of Halland. The ReDO intervention focuses on how people compose their everyday lives. Supporting people in how to change and modify their patterns of daily occupations is a new intervention method for people with stress-related disorders, but it has been shown to be effective in improving quality of life and self-rated health in other target groups. The basic idea is that re-structuring of an individual's lifestyle and pattern of daily occupations will lead to a healthier balance between the occupations of everyday life, and that this balance will promote wellness and increased work capacity. The program is group based and comprises 16 weeks, with sessions 2 x 2 hours per week, followed by 3-4 booster sessions. The aim of the research project is to evaluate the outcomes of ReDO for women with stress-related disorders. The hypothesis is that the ReDO group will improve more than a comparison group receiving "care-as-usual" (CAU) regarding return to work, sick leave, and different aspects of health and well-being. group in all these respects. The project is a quasi-experimental study. It covers the time period from entering the program to a 12-month follow-up. According to initial plans, the first 50 women who entered the ReDO program and fitted the selection criteria would be included. A power analysis indicated that 40 individuals in each group were needed to detect a medium effect size (of 0.6) with 80% power at p<.05. Forty-two women were actually recruited to the ReDO intervention. A matched comparison group was selected among those clients at the Social Insurance Office who get (CAU). The match was made on specific diagnosis, age, family situation (civil status and number of children), type of occupation and duration of sick leave. Thus, in all 84 women take part in the project. The data consist of registry information from the Social Insurance Office (SIO) and questionnaires targeting socio-demographics, perceived stress, and different aspects of health and well-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorders, Burnout, Professional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Redesigning Daily Occupations
Arm Type
Experimental
Arm Description
The ReDO intervention focuses on how people compose their everyday lives. Supporting people in how to change and modify their patterns of daily occupations is a new intervention method for people with stress-related disorders, but it has been shown to be effective in improving quality of life and self-rated health in other target groups. The basic idea is that re-structuring of an individual's lifestyle and pattern of daily occupations will lead to a healthier balance between the occupations of everyday life, and that this balance will promote wellness and improved work capacity. The program is group based and comprises 16 weeks, with sessions 2 x 2 hours per week, followed by 3-4 booster sessions.
Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
Standard rehabilitation provided by the Social Insurance Office, such as stress management, physical therapy, mindfulness training.
Intervention Type
Behavioral
Intervention Name(s)
Redesigning Daily Occupations
Intervention Description
The ReDO is a 16-week group-based programme, comprising three phases. Phase I covers five weeks and has a special focus on occupational self-analysis, while Phase II, also comprising five weeks, is concentrated around goal setting and strategies for accomplishing desired changes in the patterns of everyday activities. During these ten weeks the group meets twice a week and each session lasts for 2½ hrs. Phase III consists of work placement for six weeks, if possible in relation to the woman's ordinary work but otherwise at another relevant work place. During Phase III the group meets three times (weeks two, four and six) in order to monitor the group placement. The groups are led by two licensed occupational therapists specifically trained for the ReDO programme.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
The CAU group gets follow-ups by an officer at the Social Insurance Office, including contacts with the employer, but the additional support varies largely, from receiving relevant medical care, if any, to physical therapy and to more comprehensive rehabilitation programmes.
Primary Outcome Measure Information:
Title
Return to work
Time Frame
baseline
Title
Return to work
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Perceived stress
Time Frame
baseline
Title
Perceived stress
Time Frame
12-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Adjustment disorder or Burnout Being on sick-leave for > 2 months (full time or part time) Having an employment Exclusion Criteria: Other main diagnosis than Adjustment disorder or Burnout
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Eklund
Organizational Affiliation
Department of Health Sciences, Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halland County Concil primary health care services
City
Halmstad
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887461
Citation
Eklund M, Erlandsson LK, Wastberg BA. A longitudinal study of the working relationship and return to work: perceptions by clients and occupational therapists in primary health care. BMC Fam Pract. 2015 Apr 10;16:46. doi: 10.1186/s12875-015-0258-1.
Results Reference
derived
Links:
URL
http://www.med.lu.se/english/hvs/activity_and_health
Description
Link to the home page of the research group (currently under construction)

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Outcome Study of the ReDO Intervention for Women With Stress-related Disorders

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