Clinical trial NCT03748394: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Work Capacity
Keywords: Work capacity evaluation
Common mental disorders
Occupational therapy
Physical Therapy Modalities
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Work ability
timeFrame: change in score from baseline to 8 weeks
Secondary outcomes:
measure: Depression severity
timeFrame: change in score from baseline to 8 weeks
measure: Anxiety symptoms
timeFrame: change in score from baseline to 8 weeks
measure: Mental wellbeing
timeFrame: change in score from baseline to 8 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Närhälsan Gibraltar Rehabmottagning
Study officials:
affiliation: Göteborg University
name: Gunnel Hensing, Professor
role: PRINCIPAL_INVESTIGATOR
References: