Effects of Psycho-education of Patients With Bipolar Disorder
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
individual education
Group education
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Disorder, Psycho-education
Eligibility Criteria
Inclusion Criteria: Bipolar Disorder 1 or 2 Euthymic Exclusion Criteria: Active depression or mania/hypomania
Sites / Locations
- Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group education
individual education
Arm Description
Bipolar 1 and 2 patients in a stable euthymic phase will receive group education in 10 weekly sessions and then a session every third month for two years. Symptoms, admittances to hospital and function will be followed for two years.
Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education.
Outcomes
Primary Outcome Measures
Score on depression and mania rating scales
Admissions to hospital
Working activity
Secondary Outcome Measures
Symptoms, function, use and change in medication, need for
consultations
Full Information
NCT ID
NCT00159562
First Posted
September 9, 2005
Last Updated
June 4, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT00159562
Brief Title
Effects of Psycho-education of Patients With Bipolar Disorder
Official Title
Effects of Psycho-education of Patients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose for this study is to determine whether psycho-education in groups is more effective than individual psycho-education for patients with bipolar disorder.
Detailed Description
The main aim of the study is to compare the effects of psycho-education in groups with short individual psycho-education.
It is a randomized controlled trial including Bipolar 1 and 2 patients in a stable euthymic phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 42 or 43 patients will receive three individual sessions of education. Symptoms, admittances to hospital and function will be followed for two years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Psycho-education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group education
Arm Type
Experimental
Arm Description
Bipolar 1 and 2 patients in a stable euthymic phase will receive group education in 10 weekly sessions and then a session every third month for two years. Symptoms, admittances to hospital and function will be followed for two years.
Arm Title
individual education
Arm Type
Active Comparator
Arm Description
Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education.
Intervention Type
Behavioral
Intervention Name(s)
individual education
Intervention Description
individual sessions of psycho-education
Intervention Type
Behavioral
Intervention Name(s)
Group education
Intervention Description
group psycho-education in 10 weekly sessions and then a session every third month for two years
Primary Outcome Measure Information:
Title
Score on depression and mania rating scales
Time Frame
12 months
Title
Admissions to hospital
Time Frame
24 months
Title
Working activity
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Symptoms, function, use and change in medication, need for
Time Frame
24 months
Title
consultations
Time Frame
24 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:
Bipolar Disorder 1 or 2 Euthymic
Exclusion Criteria:
Active depression or mania/hypomania
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Morken, PhD MD
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
ZIP/Postal Code
7441
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27253214
Citation
Kallestad H, Wullum E, Scott J, Stiles TC, Morken G. The long-term outcomes of an effectiveness trial of group versus individual psychoeducation for bipolar disorders. J Affect Disord. 2016 Sep 15;202:32-8. doi: 10.1016/j.jad.2016.05.043. Epub 2016 May 24.
Results Reference
result
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Effects of Psycho-education of Patients With Bipolar Disorder
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