Effects of Psycho-education of Patients With Bipolar Disorder
This study is ongoing, but not recruiting participants.
Sponsor:
Norwegian University of Science and Technology
Collaborators:
St. Olavs Hospital
The Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159562
First received: September 9, 2005
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder |
Behavioral: individual education Behavioral: Group education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Psycho-education of Patients With Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by Norwegian University of Science and Technology:
Primary Outcome Measures:
- Score on depression and mania rating scales [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Admissions to hospital [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Working activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Symptoms, function, use and change in medication, need for [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- consultations [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: group education
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.
|
Behavioral: Group education
group psycho-education in 10 weekly sessions and then a session every third month for two years
|
|
Active Comparator: individual education
Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of 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.
|
Behavioral: individual education
individual sessions of psycho-education in 10 weekly sessions and then a session every third month for two years
|
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. 30 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 30 patients will receive three individual sessions of education. Symptoms, admittances to hospital and function will be followed for two years.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Bipolar Disorder 1 or 2 Euthymic
Exclusion Criteria:
- Active depression or mania/hypomania
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159562
Locations
| Norway | |
| Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim | |
| Trondheim, Norway, 7441 | |
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
The Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
Investigators
| Principal Investigator: | Gunnar Morken, PhD MD | Norwegian University of Science and Technology |
More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00159562 History of Changes |
| Other Study ID Numbers: | EW-2005 |
| Study First Received: | September 9, 2005 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by Norwegian University of Science and Technology:
|
Bipolar Disorder Psycho-education |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013