Effects of Psycho-education of Patients With Bipolar Disorder

NCT ID: NCT00159562

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Group education

Intervention Type BEHAVIORAL

group psycho-education in 10 weekly sessions and then a session every third month for two years

individual education

Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education.

Group Type ACTIVE_COMPARATOR

individual education

Intervention Type BEHAVIORAL

individual sessions of psycho-education

Interventions

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individual education

individual sessions of psycho-education

Intervention Type BEHAVIORAL

Group education

group psycho-education in 10 weekly sessions and then a session every third month for two years

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria

* Active depression or mania/hypomania
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian Council for Mental Health

OTHER

Sponsor Role collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Morken, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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 Sep 15;202:32-8. doi: 10.1016/j.jad.2016.05.043. Epub 2016 May 24.

Reference Type RESULT
PMID: 27253214 (View on PubMed)

Other Identifiers

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EW-2005

Identifier Type: -

Identifier Source: org_study_id

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