Interventions to Facilitate Working While Depressed and Anxious

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.

Study Overview

• Status: Unknown
• Conditions: Work Capacity
• Intervention / Treatment: Behavioral: Work-directed rehabilitation; Behavioral: Physical activity

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise Danielsson, PhD; Phone Number: +46702319907; Email: louise.danielsson@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Närhälsan Gibraltar Rehabmottagning
    • Contact: Louise Danielsson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Work-directed rehabilitation; Work-directed, person-centered plan using modules of occupational therapy and physical therapy	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
Active Comparator: Physical activity; Physical activity according to national health recommendations	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work ability	Work Ability Index	change in score from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression severity	Montgomery Asberg Depression Rating Scale	change in score from baseline to 8 weeks
Anxiety symptoms	Beck Anxiety Index	change in score from baseline to 8 weeks
Mental wellbeing	WHO-5 Mental Wellbeing Index	change in score from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Gunnel Hensing, Professor, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Occupational therapy; Physical Therapy Modalities; Common mental disorders; Work capacity evaluation
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: VGFOUREG-588531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No