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Effects of Psycho-education of Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00159562
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 7, 2016
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: individual education Behavioral: Group education Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Psycho-education of Patients With Bipolar Disorder
Study Start Date : September 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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.
Behavioral: individual education
individual sessions of psycho-education




Primary Outcome Measures :
  1. Score on depression and mania rating scales [ Time Frame: 12 months ]
  2. Admissions to hospital [ Time Frame: 24 months ]
  3. Working activity [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Symptoms, function, use and change in medication, need for [ Time Frame: 24 months ]
  2. consultations [ Time Frame: 24 months ]


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

Inclusion Criteria:

  • Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria:

  • Active depression or mania/hypomania

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): 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
Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Gunnar Morken, PhD MD Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159562     History of Changes
Other Study ID Numbers: EW-2005
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: September 2015

Keywords provided by Norwegian University of Science and Technology:
Bipolar Disorder
Psycho-education

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders