Psychoeducation to Sick-listed Individuals With Mental Health Problems

NCT ID: NCT01637363

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-02-29

Brief Summary

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In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms.

The aim of this project is to systematically compare psychoeducation with the various standard offers to sick listed individuals with mental health conditions provided by job centers in four municipalities.

Psychoeducation is employed within the psychiatric healthcare system and is defined as a group based treatment by means of educating participants about psychiatric conditions. In the present project, the employed psychoeducation focuses on psyche and work life, and its purpose is to impart knowledge about psychiatric conditions in order to provide the sick listed individuals with qualifications to understand, and, thereby, improve their own situation. Among others, there will be information about the symptoms of various psychiatric conditions, diagnoses, and treatment options. Furthermore, the participants will learn about specific, useful, cognitive tools in regards to the barriers and difficulties they might experience when reentering the work force and leave sickness absence behind.

The project is designed as a randomized clinical trial in which the participants are offered either 1) psychoeducation as well as the standard offer to sick listed individuals provided by the municipality in which the individual lives or 2) the participants are offered merely the standard offer to sick listed individuals provided by the municipality.

The target group consists of recently sick listed individuals with mental health issues - whether diagnosed or not. The individuals must be inhabitants of the municipalities of Struer, Lemvig, Skive, and Holstebro.

The outcome measure is the determined as the duration of the sickness absence, the severity of the psychiatric condition, self-reported health, and 'locus of control´. These outcome measurements are assessed at baseline and after 3 and 6 months.

Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Regular treatment

This group is offered regular treatment from the job center i.e. exercise, mindfulness

Group Type NO_INTERVENTION

No interventions assigned to this group

Psychoeducation

6 x 2 hours of psychoeducation

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

6 x 2 hours of psychoeducation

Interventions

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Psychoeducation

6 x 2 hours of psychoeducation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A score of 5 or more on SCL-8AD

Exclusion Criteria

* Sick listed due to psychiatric symptoms in a period of 3 months or longer in the last year
* pregnant
* has a flexible job
* receive pension
* not communicating in Danish
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Denmark Region

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Jørgen Søgaard, MD, ph.d.

Role: STUDY_CHAIR

Psychiatric Research Unit West, Regional Psychiatric Services

Pernille Pedersen, MHs

Role: PRINCIPAL_INVESTIGATOR

Psychiatric Research Unit West, Regional Psychiatric Services

Ellen A Nøhr, ph.d.

Role: STUDY_CHAIR

Institute of Clinical Research, University of Southern Denmark

Chris Jensen, ph.d.

Role: STUDY_CHAIR

National Advisory Unit for Occupational Rehabilitation, Rauland, Norway

Locations

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Psychiatric Research Unit West, Regional Psychiatric Services

Herning, , Denmark

Site Status

Countries

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Denmark

References

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Pedersen P, Sogaard HJ, Labriola M, Nohr EA, Jensen C. Effectiveness of psychoeducation in reducing sickness absence and improving mental health in individuals at risk of having a mental disorder: a randomised controlled trial. BMC Public Health. 2015 Aug 8;15:763. doi: 10.1186/s12889-015-2087-5.

Reference Type DERIVED
PMID: 26253219 (View on PubMed)

Pedersen P, Sogaard HJ, Yde BF, Labriola M, Nohr EA, Jensen C. Psychoeducation to facilitate return to work in individuals on sick leave and at risk of having a mental disorder: protocol of a randomised controlled trial. BMC Public Health. 2014 Dec 17;14:1288. doi: 10.1186/1471-2458-14-1288.

Reference Type DERIVED
PMID: 25516423 (View on PubMed)

Other Identifiers

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7-11-1347

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11-2-2-011

Identifier Type: -

Identifier Source: org_study_id

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