Effects of Psycho-education of Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Effects of Psycho-education of Patients With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159562
• Other study ID #: EW-2005
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: June 4, 2016
• Start date: September 2005
• Est. completion date: December 2012

Study information

• Verified date: September 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria:

• Active depression or mania/hypomania

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• individual education
individual sessions of psycho-education
• Group education
group psycho-education in 10 weekly sessions and then a session every third month for two years

Locations

Country	Name	City	State
Norway	Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 May 24;202:32-38. doi: 10.1016/j.jad.2016.05.043. [Epub ahead of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on depression and mania rating scales		12 months	No
Primary	Admissions to hospital		24 months	No
Primary	Working activity		24 months	No
Secondary	Symptoms, function, use and change in medication, need for		24 months	No
Secondary	consultations		24 months	No