Back to resultsEffects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Primary Purpose
Mental Disorder, Depressive Disorder, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorder focused on measuring Family, Coping Skills, Psychoeducation, Stress, Psychological, Health Education
Eligibility 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
Sites / Locations
- Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
1 S+E
2 S-E
3 B+E
4 B-E
Arm Description
Relatives of patients with schizophrenia, who receive education
Relatives of patients with schizophrenia, who do not receive education
Relatives of patients with bipolar disorder, who receive education
Relatives of patients with bipolar disorder, who do not receive education
Outcomes
Primary Outcome Measures
ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)
COOP/WONCA (Bowling, 1995)
Selection of questions from COPE (Carver et al. 1989)
Evaluation-questions
Secondary Outcome Measures
Full Information
NCT ID
NCT00184379
First Posted
September 13, 2005
Last Updated
August 24, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00184379
Brief Title
Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Official Title
Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of psychoeducation for relatives to patients with serious mental illness.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Depressive Disorder, Schizophrenia
Keywords
Family, Coping Skills, Psychoeducation, Stress, Psychological, Health Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 S+E
Arm Type
Experimental
Arm Description
Relatives of patients with schizophrenia, who receive education
Arm Title
2 S-E
Arm Type
No Intervention
Arm Description
Relatives of patients with schizophrenia, who do not receive education
Arm Title
3 B+E
Arm Type
Experimental
Arm Description
Relatives of patients with bipolar disorder, who receive education
Arm Title
4 B-E
Arm Type
No Intervention
Arm Description
Relatives of patients with bipolar disorder, who do not receive education
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Structured disorder-related educational program for relatives
Primary Outcome Measure Information:
Title
ECI (Experience of Caregiving Inventory) (Smuckler et al,1994)
Time Frame
0-6 months
Title
COOP/WONCA (Bowling, 1995)
Time Frame
0-6 months
Title
Selection of questions from COPE (Carver et al. 1989)
Time Frame
0-6 months
Title
Evaluation-questions
Time Frame
0-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav M Linaker, MD Prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
19192243
Citation
Moller T, Gudde CB, Folden GE, Linaker OM. The experience of caring in relatives to patients with serious mental illness: gender differences, health and functioning. Scand J Caring Sci. 2009 Mar;23(1):153-60. doi: 10.1111/j.1471-6712.2008.00605.x. Epub 2009 Jan 21.
Results Reference
result
Learn more about this trial
Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
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