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Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184379
First received: September 13, 2005
Last updated: June 11, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.


Condition Intervention
Stress
Coping Skills
 Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • ECI (Experience of Caregiving Inventory) (Smuckler et al,1994) [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • COOP/WONCA (Bowling, 1995) [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • Selection of questions from COPE (Carver et al. 1989) [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]
  • Evaluation-questions [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 S+E
Relatives of patients with schizophrenia, who receive education
 Behavioral: Psychoeducation
Structured disorder-related educational program for relatives
No Intervention: 2 S-E
Relatives of patients with schizophrenia, who do not receive education
Experimental: 3 B+E
Relatives of patients with bipolar disorder, who receive education
 Behavioral: Psychoeducation
Structured disorder-related educational program for relatives
No Intervention: 4 B-E
Relatives of patients with bipolar disorder, who do not receive education

Detailed Description:

The main aim of the study is to compare the effects of group psychoeducation for relatives to patients with serious mental illness with a waiting list control group. The main hypothesis is whether psychoeducation in groups has effects on the stress experience and coping style in the relatives. The relatives will receive group education in 6 weekly sessions. We will measure stress experience, coping style and the relatives' health condition before the sessions, after the sessions and at one year follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relatives to patients having a psychotic or bipolar disorder
  • Aged 18-70 years old
  • Good Norwegian language skills
  • Consent to participate
  • The patients' consent for their relatives to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184379

Locations
Norway
Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Olav M Linaker, MD, Professor Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Olav M. Linaker/ Professor, MD, PhD., Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184379     History of Changes
Other Study ID Numbers: 4.2005.389
Study First Received: September 13, 2005
Last Updated: June 11, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Relatives to
patients
with
serious
 mental
illness
Psychoeducation

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013