Adjustment DisordersNCT01234961
Outcome Study of the ReDO Intervention for Women With Stress-related Disorders
A study testing Redesigning Daily Occupations and Care as usual in people with Adjustment Disorders and Burnout, Professional, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- Adjustment Disorders, Burnout, Professional
- What is being tested?
- Redesigning Daily Occupations and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Adjustment disorder or Burnout
- Being on sick-leave for > 2 months (full time or part time)
- Having an employment
Who cannot join
- Other main diagnosis than Adjustment disorder or Burnout
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of the Work Rehabilitation Method Redesigning Daily Occupations (ReDO) - a Quasi-experimental Study Among Women With Stress-related Disorders
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.
Read the 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.
- Conditions
- Adjustment Disorders, Burnout, Professional
- Being tested
- Redesigning Daily Occupations, Care as usual
- Medical subject headings
- Adjustment Disorders, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redesigning Daily OccupationsBehavioural
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.
Care as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Measured: baseline
Return to work
Measured: 12-months
Secondary outcomes (2)
Perceived stress
Measured: baseline
Perceived stress
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisordersStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Mona Eklund, Lund University
- Investigators
- Mona Eklund, Principal investigator, Department of Health Sciences, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234961
- Sponsor's protocol ID
- FAS2005_ME
- Other IDs
- 2004-0615
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2010
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25887461
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the Work Rehabilitation Method Redesigning Daily Occupations (ReDO) - a Quasi-experimental Study Among Women With Stress-related Disorders
- ClinicalTrials.gov ID
- NCT01234961
- Acronym / sponsor ID
- FAS2005_ME
- Conditions
- Adjustment Disorders, Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Redesigning Daily Occupations | Experimental | Behavioral: Redesigning Daily OccupationsThe 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. |
| Care as usual | Active comparator | Other: Care as usualStandard rehabilitation provided by the Social Insurance Office, such as stress management, physical therapy, mindfulness training. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Adjustment disorder or Burnout
- Being on sick-leave for > 2 months (full time or part time)
- Having an employment
Key exclusion criteria (1 listed)
- Other main diagnosis than Adjustment disorder or Burnout
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redesigning Daily OccupationsThe 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. | Behavioural | Redesigning Daily Occupations |
| Care as usualThe 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. | Other | Care as usual |
Primary outcome
Return to work
Time frame: baseline
Return to work
Time frame: 12-months
2 secondary outcomes
Perceived stress
Time frame: baseline
Perceived stress
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 25887461Eklund 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.
- Link to the home page of the research group (currently under construction)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Eklund principal investigator
Department of Health Sciences, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redesigning Daily Occupations and Care as usual in people with Adjustment Disorders and Burnout, Professional, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.