Clinical trial NCT01637363: Psychoeducation to Sick-listed Individuals With Mental Health Problems
Official title: Psychoeducation to Sick-listed Individuals With Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Psychoeducation
Stress
Sickness absence
Psychiatric symptoms
Locus of control
Self reported health
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
First posted: 2012-07-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: length of sickness absence
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Locus of control
timeFrame: Baseline, 3 and 6 months after randomization
measure: Self reported health
timeFrame: Baseline, 3 and 6 months after randomization
measure: Psychological symptoms
timeFrame: Baseline, 3 and 6 months after randomization
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Psychiatric Research Unit West, Regional Psychiatric Services
Study officials:
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services
name: Hans Jørgen Søgaard, MD, ph.d.
role: STUDY_CHAIR
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services
name: Pernille Pedersen, MHs
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Research, University of Southern Denmark
name: Ellen A Nøhr, ph.d.
role: STUDY_CHAIR
affiliation: National Advisory Unit for Occupational Rehabilitation, Rauland, Norway
name: Chris Jensen, ph.d.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.