NCT03748394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

December 28, 2016

Last Update Submit

November 19, 2018

Conditions

Keywords

Work capacity evaluationCommon mental disordersOccupational therapyPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

  • Work ability

    Work Ability Index

    change in score from baseline to 8 weeks

Secondary Outcomes (3)

  • Depression severity

    change in score from baseline to 8 weeks

  • Anxiety symptoms

    change in score from baseline to 8 weeks

  • Mental wellbeing

    change in score from baseline to 8 weeks

Study Arms (2)

Work-directed rehabilitation

EXPERIMENTAL

Work-directed, person-centered plan using modules of occupational therapy and physical therapy

Behavioral: Work-directed rehabilitation

Physical activity

ACTIVE COMPARATOR

Physical activity according to national health recommendations

Behavioral: Physical activity

Interventions

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

Work-directed rehabilitation

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.

Physical activity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Substance abuse according to the Mini interview
  • High suicide risk according to the Mini interview
  • Psychotic symptoms according to the Mini interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Närhälsan Gibraltar Rehabmottagning

Gothenburg, Sweden

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gunnel Hensing, Professor

    Göteborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Danielsson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

November 20, 2018

Study Start

February 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations