NCT00159562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 7, 2016

Status Verified

September 1, 2015

Enrollment Period

6.3 years

First QC Date

September 9, 2005

Last Update Submit

June 4, 2016

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderPsycho-education

Outcome Measures

Primary Outcomes (3)

  • Score on depression and mania rating scales

    12 months

  • Admissions to hospital

    24 months

  • Working activity

    24 months

Secondary Outcomes (2)

  • Symptoms, function, use and change in medication, need for

    24 months

  • consultations

    24 months

Study Arms (2)

group education

EXPERIMENTAL

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

individual education

ACTIVE COMPARATOR

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

Behavioral: individual education

Interventions

individual educationBEHAVIORAL

individual sessions of psycho-education

individual education
Group educationBEHAVIORAL

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

group education

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar Disorder 1 or 2 Euthymic

You may not qualify if:

  • Active depression or mania/hypomania

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trondheim, 7441, Norway

Location

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

    PMID: 27253214RESULT

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gunnar Morken, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

June 7, 2016

Record last verified: 2015-09

Locations

NO(1)