Work CapacityNCT03748394
Interventions to Facilitate Working While Depressed and Anxious
A study testing Work-directed rehabilitation and Physical activity in people with Work Capacity, run by Göteborg University at 1 site in Sweden.
Trial summary
The study compares the effects of two add-on interventions in primary care rehabilitation, on work ability and psychological health, in workers with common mental disorders. One intervention consists of a person-centered plan using work-directed treatment modules of occupational therapy and physical therapy, during 8… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Work Capacity
- What is being tested?
- Work-directed rehabilitation and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unipolar depression or anxiety disorder according to the Mini Neuropsychiatric Interview (DSM-5 criteria).
- Currently working to some extent, part time sick leave is accepted.
Who cannot join
- Substance abuse according to the Mini interview
- High suicide risk according to the Mini interview
- Psychotic symptoms according to the Mini interview
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Närhälsan Gibraltar Rehabmottagning
Gothenburg
Louise Danielsson, PhD
About this study
Official title: Enhancing Work Ability in Common Mental Disorders: Comparing Two Interventions in Primary Care Rehabilitation
The study compares the effects of two add-on interventions in primary care rehabilitation, on work ability and psychological health, in workers with common mental disorders. One intervention consists of a person-centered plan using work-directed treatment modules of occupational therapy and physical therapy, during 8 weeks. The other intervention consists of supported physical activity during 8 weeks. The primary outcome is work ability, measured by the work ability index and days on sick leave.
Read the detailed description
Common mental disorders (CMD), including mild to moderate depression, anxiety disorders and exhaustion disorder, are a major cause of sick leave and work disability. Compared to other disorders, work-related problems associated with CMD is sparsely explored. While recommended treatments, such as antidepressants or cognitive behavioral therapy have effects on psychiatric symptoms, the effect on work capacity is unclear, suggesting a need for alternative interventions.
The aim of this study is to evaluate the effects of an add-on work-directed intervention in primary care rehabilitation, compared to a physical activity control, for persons with CMD.
The goal of the experimental condition is to enhance the participant's ability to work by creating an individually tailored plan for self-management, supported by occupational and physical therapy techniques, such as structuring daily activities, stress management or body awareness techniques. Enhancing self-management is the core of this intervention and also a new approach compared to earlier efforts to promote work capacity.
- Conditions
- Work Capacity
- Being tested
- Work-directed rehabilitation, Physical activity
- Keywords
- Work capacity evaluation, Common mental disorders, Occupational therapy, Physical Therapy Modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work-directed rehabilitationBehavioural
Each participant starts with a meeting together with an occupational therapist or a physical therapist, focusing on the participant's resources and obstacles for functioning well at work. A plan is designed and carried out over 8 weeks, including 1-4 different treatment modules of occupational and physical therapy, to support the person's ability to function at work
Physical activityBehavioural
In a meeting with a physical therapist, each participant receives advice on physical activity to support mental health, according to national recommendations. The participant is offered to train at a local gym during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Work-directed rehabilitation | Experimental | Work-directed, person-centered plan using modules of occupational therapy and physical therapy Receives: Behavioral: Work-directed rehabilitation |
| Physical activity | Active comparator | Physical activity according to national health recommendations Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work ability
Work Ability Index
Measured: change in score from baseline to 8 weeks
Secondary outcomes (3)
Depression severity
Montgomery Asberg Depression Rating Scale
Measured: change in score from baseline to 8 weeks
Anxiety symptoms
Beck Anxiety Index
Measured: change in score from baseline to 8 weeks
Mental wellbeing
WHO-5 Mental Wellbeing Index
Measured: change in score from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Feb 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work CapacityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnel Hensing, Professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748394
- Sponsor's protocol ID
- VGFOUREG-588531
- Status last verified
- Nov 2018
- First submitted
- 28 Dec 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Work Ability in Common Mental Disorders: Comparing Two Interventions in Primary Care Rehabilitation
- ClinicalTrials.gov ID
- NCT03748394
- Acronym / sponsor ID
- VGFOUREG-588531
- Conditions
- Work Capacity
- Keywords
- Work capacity evaluation, Common mental disorders, Occupational therapy, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 2018 (actual)
- 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.
The study compares the effects of two add-on interventions in primary care rehabilitation, on work ability and psychological health, in workers with common mental disorders. One intervention consists of a person-centered plan using work-directed treatment modules of occupational therapy and physical therapy, during 8 weeks. The other intervention consists of supported physical activity during 8 weeks. The primary outcome is work ability, measured by the work ability index and days on sick leave.
Detailed description
Common mental disorders (CMD), including mild to moderate depression, anxiety disorders and exhaustion disorder, are a major cause of sick leave and work disability. Compared to other disorders, work-related problems associated with CMD is sparsely explored. While recommended treatments, such as antidepressants or cognitive behavioral therapy have effects on psychiatric symptoms, the effect on work capacity is unclear, suggesting a need for alternative interventions.
The aim of this study is to evaluate the effects of an add-on work-directed intervention in primary care rehabilitation, compared to a physical activity control, for persons with CMD.
The goal of the experimental condition is to enhance the participant's ability to work by creating an individually tailored plan for self-management, supported by occupational and physical therapy techniques, such as structuring daily activities, stress management or body awareness techniques. Enhancing self-management is the core of this intervention and also a new approach compared to earlier efforts to promote work capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Work-directed rehabilitation | Experimental | Behavioral: Work-directed rehabilitationWork-directed, person-centered plan using modules of occupational therapy and physical therapy |
| Physical activity | Active comparator | Behavioral: Physical activityPhysical activity according to national health recommendations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unipolar depression or anxiety disorder according to the Mini Neuropsychiatric Interview (DSM-5 criteria).
- Currently working to some extent, part time sick leave is accepted.
Key exclusion criteria (3 listed)
- Substance abuse according to the Mini interview
- High suicide risk according to the Mini interview
- Psychotic symptoms according to the Mini interview
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 |
|---|---|---|
| Work-directed rehabilitationEach participant starts with a meeting together with an occupational therapist or a physical therapist, focusing on the participant's resources and obstacles for functioning well at work. A plan is designed and carried out over 8 weeks, including 1-4 different treatment modules of occupational and physical therapy, to support the person's ability to function at work | Behavioural | Work-directed rehabilitation |
| Physical activityIn a meeting with a physical therapist, each participant receives advice on physical activity to support mental health, according to national recommendations. The participant is offered to train at a local gym during 8 weeks. | Behavioural | Physical activity |
Primary outcome
Work ability
Time frame: change in score from baseline to 8 weeks
Work Ability Index
3 secondary outcomes
Depression severity
Time frame: change in score from baseline to 8 weeks
Anxiety symptoms
Time frame: change in score from baseline to 8 weeks
Mental wellbeing
Time frame: change in score from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Gunnel Hensing, Professor principal investigator
Göteborg 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 Work-directed rehabilitation and Physical activity in people with Work Capacity, run by Göteborg 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Danielsson, PhD (+46702319907, louise.danielsson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work ability (time frame: change in score from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.