Psychoeducation to Sick-listed Individuals With Mental Health Problems

NCT01637363 | Completed

• 2 other identifiers: 11-2-2-0117-11-1347
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

Psychoeducation; Stress; Sickness absence; Psychiatric symptoms; Locus of control; Self reported health

Outcome Measures

Primary Outcomes (1)

• length of sickness absence

  6 months after randomization

Secondary Outcomes (3)

• Locus of control

  Baseline, 3 and 6 months after randomization

• Self reported health

  Baseline, 3 and 6 months after randomization

• Psychological symptoms

  Baseline, 3 and 6 months after randomization

Study Arms (2)

Regular treatment

NO INTERVENTION

This group is offered regular treatment from the job center i.e. exercise, mindfulness

Psychoeducation

EXPERIMENTAL

6 x 2 hours of psychoeducation

Behavioral: Psychoeducation

Interventions

Psychoeducation BEHAVIORAL

6 x 2 hours of psychoeducation

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A score of 5 or more on SCL-8AD

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Study Sites (1)

Psychiatric Research Unit West, Regional Psychiatric Services

Herning, 7400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 26253219 DERIVED

• 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.

  PMID: 25516423 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Hans Jørgen Søgaard, MD, ph.d.

  Psychiatric Research Unit West, Regional Psychiatric Services

  STUDY CHAIR

• Pernille Pedersen, MHs

  Psychiatric Research Unit West, Regional Psychiatric Services

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

DK (1)