Can Psychotherapy Reduce Sickness Absence? | NCT01181635

Studies
Can Psychotherapy Reduce Sickness Absence?

NCT01181635

Sponsor

Lovisenberg Diakonale Hospital

Status

Unknown status

Last Update Posted

Aug 9, 2019Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Mental Disorders

Interventions

Psychotherapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Aug 12, 2010

First Submission Date that Met QC Criteria

Aug 12, 2010

First Posted Date

Aug 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2019

Last Update Posted Date

Aug 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine if psychotherapy can reduce sickness absence.

Detailed Description

Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychotherapy	Experimental	Short-term pychotherapy and/or psychoeduchative courses.	Behavioral: Psychotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy	Behavioral	Standard psychotherapy for psychiatric disorders.	Psychotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sickness absence	Present status (working or sick).	Before, after and 6 months after treatment.

Secondary Outcomes

Measure	Description	Time Frame
Psychiatric symptoms	CORE-OM.	Before, after and 6 months after treatment.
Quality of life (QALY)	15 D	Before, after and 6 months after treatment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjørn Lau, phd	Lovisenberg Diakonale Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lovisenberg diakonale sykehus, Lovisenberg DPS		Oslo		0440	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29234955	Derived	Victor M, Lau B, Ruud T. Predictors of Return to Work 6 Months After the End of Treatment in Patients with Common Mental Disorders: A Cohort Study. J Occup Rehabil. 2018 Sep;28(3):548-558. doi: 10.1007/s10926-017-9747-5.
28720129	Derived	Victor M, Lau B, Ruud T. Predictors of return to work among patients in treatment for common mental disorders: a pre-post study. BMC Public Health. 2017 Jul 18;18(1):27. doi: 10.1186/s12889-017-4581-4.