Psychoeducation to Sick-listed Individuals With Mental Health Problems

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01637363
First received: July 6, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Stress, Psychological
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychoeducation to Sick-listed Individuals With Mental Health Problems

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • length of sickness absence [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Locus of control [ Time Frame: Baseline, 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • Self reported health [ Time Frame: Baseline, 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • Psychological symptoms [ Time Frame: Baseline, 3 and 6 months after randomization ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Regular treatment
This group is offered regular treatment from the job center i.e. exercise, mindfulness
Experimental: Psychoeducation
6 x 2 hours of psychoeducation
Behavioral: Psychoeducation
6 x 2 hours of psychoeducation

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637363

Locations
Denmark
Psychiatric Research Unit West, Regional Psychiatric Services
Herning, Denmark, 7400
Sponsors and Collaborators
University of Aarhus
Central Denmark Region
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01637363     History of Changes
Other Study ID Numbers: 11-2-2-011, 7-11-1347
Study First Received: July 6, 2012
Last Updated: February 27, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Psychoeducation
Stress
Sickness absence
Psychiatric symptoms
Locus of control
Self reported health

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014