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

This study has been completed.
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by (Responsible Party):
Mona Eklund, Lund University
ClinicalTrials.gov Identifier:
NCT01234961
First received: November 2, 2010
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Adjustment Disorders
Burnout, Professional
Behavioral: Redesigning Daily Occupations
Other: Care as usual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes of the Work Rehabilitation Method Redesigning Daily Occupations (ReDO) - a Quasi-experimental Study Among Women With Stress-related Disorders

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Return to work [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Return to work [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived stress [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Perceived stress [ Time Frame: 12-months ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Redesigning Daily Occupations
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.
Behavioral: Redesigning Daily Occupations
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.
Active Comparator: Care as usual
Standard rehabilitation provided by the Social Insurance Office, such as stress management, physical therapy, mindfulness training.
Other: Care as usual
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234961

Locations
Sweden
Halland County Concil primary health care services
Halmstad, Sweden
Sponsors and Collaborators
Lund University
Swedish Council for Working Life and Social Research
Investigators
Principal Investigator: Mona Eklund Department of Health Sciences, Lund University
  More Information

Additional Information:
No publications provided

Responsible Party: Mona Eklund, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01234961     History of Changes
Other Study ID Numbers: FAS2005_ME, 2004-0615
Study First Received: November 2, 2010
Last Updated: November 13, 2012
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Adjustment Disorders
Psychophysiologic Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014