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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


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
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