Effects of Psycho-education of Patients With Bipolar Disorder

This study has been completed.
Sponsor:
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: December 17, 2013
Last verified: December 2013
  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 ]

Enrollment: 82
Study Start Date: September 2005
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
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, see Learn About Clinical Studies.

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: December 17, 2013
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
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014