Interventions to Facilitate Working While Depressed and Anxious

Work Capacity Clinical Trial

Official title:

Enhancing Work Ability in Common Mental Disorders: Comparing Two Interventions in Primary Care Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03748394
• Other study ID #: VGFOUREG-588531
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Göteborg University
• Contact: Louise Danielsson, PhD
• Phone: +46702319907
• Email: louise.danielsson[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Work Capacity

Intervention

Behavioral:
• Work-directed rehabilitation
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 activity
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.

Locations

Country	Name	City	State
Sweden	Närhälsan Gibraltar Rehabmottagning	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work ability	Work Ability Index	change in score from baseline to 8 weeks
Secondary	Depression severity	Montgomery Asberg Depression Rating Scale	change in score from baseline to 8 weeks
Secondary	Anxiety symptoms	Beck Anxiety Index	change in score from baseline to 8 weeks
Secondary	Mental wellbeing	WHO-5 Mental Wellbeing Index	change in score from baseline to 8 weeks