Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01234961
Other study ID # FAS2005_ME
Secondary ID 2004-0615
Status Completed
Phase N/A
First received November 2, 2010
Last updated November 13, 2012
Start date September 2007
Est. completion date August 2011

Study information

Verified date November 2012
Source Lund University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 64 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
Sweden Halland County Concil primary health care services Halmstad

Sponsors (2)

Lead Sponsor Collaborator
Lund University Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Return to work baseline No
Primary Return to work 12-months No
Secondary Perceived stress baseline No
Secondary Perceived stress 12-months No
See also
  Status Clinical Trial Phase
Completed NCT03614390 - Mindfulness for Medical Students N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Completed NCT03473353 - Doctor-Parent Interactions With Medical Scribes N/A
Recruiting NCT05483335 - Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates
Terminated NCT04132141 - VR Breaks on Shift-worker Alertness N/A
Completed NCT05519267 - Mindfulness-based Social Work and Self-Care (MBSWSC) N/A
Not yet recruiting NCT04665505 - Resource Optimization in the Intensive Care Unit Setting N/A
Completed NCT02455947 - IBSR Meditation Technique for Teachers' Burnout N/A
Completed NCT04004806 - Tracking Device Guided Feedback to Enhance Patient Physician Interaction N/A
Completed NCT04129632 - Evaluation of Institutional Resources and a Novel Mindfulness Tool on Burnout Intensity N/A
Completed NCT03303482 - A Randomized Controlled Trial of Trauma-awareness Training for Early Childhood Educators N/A
Recruiting NCT05011435 - Assessment of the Feasibility of Using a Smartphone Application for the Prevention and Screening of Burnout (BURNOUT ADVICE)
Active, not recruiting NCT04517136 - Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions
Active, not recruiting NCT05387746 - Integrative Self-care Approaches for HCP Wellbeing N/A
Completed NCT05222685 - Better Together Physician Coaching: An Innovative Solution to Medical Trainee Burnout N/A
Completed NCT02544412 - A Well-being Training for Preservice Teachers N/A
Completed NCT04466423 - Intervention Trial to Increase Meaning in Work and Reduce Burnout N/A
Completed NCT03475290 - Internet-Based Intervention for Occupational Stress Among Medical Professionals N/A
Completed NCT05538650 - RCT: Mindfulness for Social Work and Self-care N/A
Completed NCT05574764 - ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff N/A