Effects of Psycho-education of Patients With Bipolar Disorder

June 4, 2016 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7441
        • Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria:

  • Active depression or mania/hypomania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on depression and mania rating scales
Time Frame: 12 months
12 months
Admissions to hospital
Time Frame: 24 months
24 months
Working activity
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms, function, use and change in medication, need for
Time Frame: 24 months
24 months
consultations
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Norwegian Council for Mental Health
St. Olavs Hospital
Norwegian Foundation for Health and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 7, 2016

Last Update Submitted That Met QC Criteria

June 4, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EW-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe