Psychoeducation to Sick-listed Individuals With Mental Health Problems

Stress, Psychological Clinical Trial

Official title:

Psychoeducation to Sick-listed Individuals With Mental Health Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637363
• Other study ID #: 11-2-2-011
• Secondary ID: 7-11-1347
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: May 11, 2016
• Start date: September 2012
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• Psychoeducation
6 x 2 hours of psychoeducation

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit West, Regional Psychiatric Services	Herning

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of sickness absence		6 months after randomization	No
Secondary	Locus of control		Baseline, 3 and 6 months after randomization	No
Secondary	Self reported health		Baseline, 3 and 6 months after randomization	No
Secondary	Psychological symptoms		Baseline, 3 and 6 months after randomization	No

External Links

•   Project homepage