Clinical trial NCT01234961: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorders
Burnout, Professional
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2010-11-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Return to work
timeFrame: baseline
measure: Return to work
timeFrame: 12-months
Secondary outcomes:
measure: Perceived stress
timeFrame: baseline
measure: Perceived stress
timeFrame: 12-months
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Halland County Concil primary health care services
Study officials:
affiliation: Department of Health Sciences, Lund University
name: Mona Eklund
role: PRINCIPAL_INVESTIGATOR
References:
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.