Psychoeducation to Sick-listed Individuals With Mental Health Problems
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Psychological focused on measuring Psychoeducation, Stress, Sickness absence, Psychiatric symptoms, Locus of control, Self reported health
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
Sites / Locations
- Psychiatric Research Unit West, Regional Psychiatric Services
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Regular treatment
Psychoeducation
Arm Description
This group is offered regular treatment from the job center i.e. exercise, mindfulness
6 x 2 hours of psychoeducation
Outcomes
Primary Outcome Measures
length of sickness absence
Secondary Outcome Measures
Locus of control
Self reported health
Psychological symptoms
Full Information
NCT ID
NCT01637363
First Posted
July 6, 2012
Last Updated
May 11, 2016
Sponsor
University of Aarhus
Collaborators
Central Denmark Region
1. Study Identification
Unique Protocol Identification Number
NCT01637363
Brief Title
Psychoeducation to Sick-listed Individuals With Mental Health Problems
Official Title
Psychoeducation to Sick-listed Individuals With Mental Health Problems
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Central Denmark Region
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Psychoeducation, Stress, Sickness absence, Psychiatric symptoms, Locus of control, Self reported health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular treatment
Arm Type
No Intervention
Arm Description
This group is offered regular treatment from the job center i.e. exercise, mindfulness
Arm Title
Psychoeducation
Arm Type
Experimental
Arm Description
6 x 2 hours of psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
6 x 2 hours of psychoeducation
Primary Outcome Measure Information:
Title
length of sickness absence
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Locus of control
Time Frame
Baseline, 3 and 6 months after randomization
Title
Self reported health
Time Frame
Baseline, 3 and 6 months after randomization
Title
Psychological symptoms
Time Frame
Baseline, 3 and 6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Jørgen Søgaard, MD, ph.d.
Organizational Affiliation
Psychiatric Research Unit West, Regional Psychiatric Services
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pernille Pedersen, MHs
Organizational Affiliation
Psychiatric Research Unit West, Regional Psychiatric Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen A Nøhr, ph.d.
Organizational Affiliation
Institute of Clinical Research, University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris Jensen, ph.d.
Organizational Affiliation
National Advisory Unit for Occupational Rehabilitation, Rauland, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Psychiatric Research Unit West, Regional Psychiatric Services
City
Herning
ZIP/Postal Code
7400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26253219
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.
Results Reference
derived
PubMed Identifier
25516423
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.
Results Reference
derived
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Psychoeducation to Sick-listed Individuals With Mental Health Problems
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