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Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184379
First Posted: September 16, 2005
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.

Condition Intervention
Mental Disorder Depressive Disorder Schizophrenia Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness

Resource links provided by NLM:


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 ]
  • COOP/WONCA (Bowling, 1995) [ Time Frame: 0-6 months ]
  • Selection of questions from COPE (Carver et al. 1989) [ Time Frame: 0-6 months ]
  • Evaluation-questions [ Time Frame: 0-6 months ]

Enrollment: 50
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relatives to patients having a psychotic or bipolar disorder
  • Good Norwegian language skills
  • Consent to participate
  • The patients' consent for their relatives to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Prof Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184379     History of Changes
Other Study ID Numbers: 4.2005.389
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: August 28, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Family
Coping Skills
Psychoeducation
Stress, Psychological
Health Education

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Behavioral Symptoms