Psychoeducation to Sick-listed Individuals With Mental Health Problems
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|ClinicalTrials.gov Identifier: NCT01637363|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Behavioral: Psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Psychoeducation to Sick-listed Individuals With Mental Health Problems|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
No Intervention: Regular treatment
This group is offered regular treatment from the job center i.e. exercise, mindfulness
6 x 2 hours of psychoeducation
6 x 2 hours of psychoeducation
- length of sickness absence [ Time Frame: 6 months after randomization ]
- Locus of control [ Time Frame: Baseline, 3 and 6 months after randomization ]
- Self reported health [ Time Frame: Baseline, 3 and 6 months after randomization ]
- Psychological symptoms [ Time Frame: Baseline, 3 and 6 months after randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637363
|Psychiatric Research Unit West, Regional Psychiatric Services|
|Herning, Denmark, 7400|
|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|