Psychoeducation to Sick-listed Individuals With Mental Health Problems

May 11, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Psychiatric Research Unit West, Regional Psychiatric Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Regular treatment
This group is offered regular treatment from the job center i.e. exercise, mindfulness
Experimental: Psychoeducation
6 x 2 hours of psychoeducation
Behavioral: Psychoeducation
6 x 2 hours of psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of sickness absence
Time Frame: 6 months after randomization
6 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Locus of control
Time Frame: Baseline, 3 and 6 months after randomization
Baseline, 3 and 6 months after randomization
Self reported health
Time Frame: Baseline, 3 and 6 months after randomization
Baseline, 3 and 6 months after randomization
Psychological symptoms
Time Frame: Baseline, 3 and 6 months after randomization
Baseline, 3 and 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region

Investigators

  • Study Chair: Hans Jørgen Søgaard, MD, ph.d., Psychiatric Research Unit West, Regional Psychiatric Services
  • Principal Investigator: Pernille Pedersen, MHs, Psychiatric Research Unit West, Regional Psychiatric Services
  • Study Chair: Ellen A Nøhr, ph.d., Institute of Clinical Research, University of Southern Denmark
  • Study Chair: Chris Jensen, ph.d., National Advisory Unit for Occupational Rehabilitation, Rauland, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2-2-011
  • 7-11-1347 (Other Grant/Funding Number: Tryg Fonden)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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