NCT01989728

Brief Summary

The hypothesis was that a large fraction of individuals with common mental disorders were undetected in long-term sickness and that detection of the disorders by screening, a psychiatric diagnostic examination and feedback to the individuals, primary care, and rehabilitation officers improved return to work, improved quality of life and reduced psychological distress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,121

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

November 8, 2013

Last Update Submit

November 14, 2013

Conditions

Psychiatric DisordersCommon Mental DisordersDepressionAnxietySomatoform Disorder

Keywords

sickness absence, return to work, psychiatric examination, feedback, psychological distress, quality of life, attrition analysis, multiple imputation

Outcome Measures

Primary Outcomes (1)

  • duration until return to work

    Included individuals were followed until payment of sickness absence compensation was ended

    1-2 years

Secondary Outcomes (1)

  • Psychological distress by subscales of Hopkins Symptom Checklist Revised (SCL-90-R)

    1 year

Other Outcomes (1)

  • Quality of life by means of Social Functioning) SF-36

    1 year

Study Arms (2)

care as usual

ACTIVE COMPARATOR
Procedure: psychiatric examination and feedback

psychiatric examination and feedback

EXPERIMENTAL
Procedure: psychiatric examination and feedback

Interventions

psychiatric examination and feedbackPROCEDURE
care as usualpsychiatric examination and feedback

Eligibility Criteria

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

You may qualify if:

  • First sick-listing between August 30, 2004 and August 29, 2005 in six municipalities (118,000 inhabitants)

You may not qualify if:

  • Unable to understand Danish and absence due to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit west, regional Psychiatric Services West

Herning, 7400, Denmark

Location

Related Publications (7)

  • Sogaard HJ, Bech P. Psychiatric disorders in long-term sickness absence -- a population-based cross-sectional study. Scand J Public Health. 2009 Sep;37(7):682-9. doi: 10.1177/1403494809344357. Epub 2009 Aug 21.

    PMID: 19700479RESULT

  • Sogaard HJ, Bech P. Psychometric analysis of common mental disorders -- Screening Questionnaire (CMD-SQ) in long-term sickness absence. Scand J Public Health. 2009 Nov;37(8):855-63. doi: 10.1177/1403494809344653. Epub 2009 Aug 28.

    PMID: 19717571RESULT

  • Sogaard HJ. Choosing screening instrument and cut-point on screening instruments. A comparison of methods. Scand J Public Health. 2009 Nov;37(8):872-80. doi: 10.1177/1403494809344442. Epub 2009 Aug 28.

    PMID: 19717573RESULT

  • Sogaard HJ, Bech P. The effect on length of sickness absence by recognition of undetected psychiatric disorder in long-term sickness absence. A randomized controlled trial. Scand J Public Health. 2009 Nov;37(8):864-71. doi: 10.1177/1403494809347551. Epub 2009 Sep 7.

    PMID: 19736249RESULT

  • Sogaard HJ, Bech P. Predictive validity of common mental disorders screening questionnaire as a screening instrument in long term sickness absence. Scand J Public Health. 2010 Jun;38(4):375-85. doi: 10.1177/1403494809350520. Epub 2009 Oct 22.

    PMID: 19850649RESULT

  • Sogaard HJ, Bech P. Compensating for non-response in a study estimating the incidence of mental disorders in long-term sickness absence by a two-phased design. Scand J Public Health. 2010 Aug;38(6):625-32. doi: 10.1177/1403494810373673. Epub 2010 Jun 7.

    PMID: 20529969RESULT

  • Sogaard HJ, Bech P. The effect of detecting undetected common mental disorders on psychological distress and quality of life in long-term sickness absence: a randomised controlled trial. Scand J Public Health. 2010 Dec;38(8):845-56. doi: 10.1177/1403494810379292. Epub 2010 Jul 22.

    PMID: 20651000RESULT

MeSH Terms

Conditions

Mental DisordersDepressionAnxiety DisordersSomatoform Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, consultant, prof. ph.d.

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 21, 2013

Study Start

November 1, 2004

Primary Completion

October 1, 2005

Study Completion

December 1, 2010

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

DK(1)