NCT01234961

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

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 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

3.9 years

First QC Date

November 2, 2010

Last Update Submit

November 13, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • Return to work

    baseline

  • Return to work

    12-months

Secondary Outcomes (2)

  • Perceived stress

    baseline

  • Perceived stress

    12-months

Study Arms (2)

Redesigning Daily Occupations

EXPERIMENTAL

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

Care as usual

ACTIVE COMPARATOR

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

Other: Care as usual

Interventions

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.

Redesigning Daily Occupations

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.

Care as usual

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other main diagnosis than Adjustment disorder or Burnout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halland County Concil primary health care services

Halmstad, Sweden

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Adjustment DisordersBurnout, Professional

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Mona Eklund

    Department of Health Sciences, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 4, 2010

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations