Interventions to Facilitate Working While Depressed and Anxious
Primary Purpose
Work Capacity
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Work-directed rehabilitation
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Work Capacity focused on measuring Work capacity evaluation, Common mental disorders, Occupational therapy, Physical Therapy Modalities
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Substance abuse according to the Mini interview
- High suicide risk according to the Mini interview
- Psychotic symptoms according to the Mini interview
Sites / Locations
- Närhälsan Gibraltar RehabmottagningRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Work-directed rehabilitation
Physical activity
Arm Description
Work-directed, person-centered plan using modules of occupational therapy and physical therapy
Physical activity according to national health recommendations
Outcomes
Primary Outcome Measures
Work ability
Work Ability Index
Secondary Outcome Measures
Depression severity
Montgomery Asberg Depression Rating Scale
Anxiety symptoms
Beck Anxiety Index
Mental wellbeing
WHO-5 Mental Wellbeing Index
Full Information
NCT ID
NCT03748394
First Posted
December 28, 2016
Last Updated
November 19, 2018
Sponsor
Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT03748394
Brief Title
Interventions to Facilitate Working While Depressed and Anxious
Official Title
Enhancing Work Ability in Common Mental Disorders: Comparing Two Interventions in Primary Care Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Capacity
Keywords
Work capacity evaluation, Common mental disorders, Occupational therapy, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Work-directed rehabilitation
Arm Type
Experimental
Arm Description
Work-directed, person-centered plan using modules of occupational therapy and physical therapy
Arm Title
Physical activity
Arm Type
Active Comparator
Arm Description
Physical activity according to national health recommendations
Intervention Type
Behavioral
Intervention Name(s)
Work-directed rehabilitation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work ability
Description
Work Ability Index
Time Frame
change in score from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Depression severity
Description
Montgomery Asberg Depression Rating Scale
Time Frame
change in score from baseline to 8 weeks
Title
Anxiety symptoms
Description
Beck Anxiety Index
Time Frame
change in score from baseline to 8 weeks
Title
Mental wellbeing
Description
WHO-5 Mental Wellbeing Index
Time Frame
change in score from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Substance abuse according to the Mini interview
High suicide risk according to the Mini interview
Psychotic symptoms according to the Mini interview
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Danielsson, PhD
Phone
+46702319907
Email
louise.danielsson@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnel Hensing, Professor
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Närhälsan Gibraltar Rehabmottagning
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Danielsson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interventions to Facilitate Working While Depressed and Anxious
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