Bipolar DisorderNCT00159562
Effects of Psycho-education of Patients With Bipolar Disorder
A study testing individual education and Group education in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- individual education and Group education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar Disorder 1 or 2 Euthymic
Who cannot join
- Active depression or mania/hypomania
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Trondheim, 7441
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- individual education, Group education
- Keywords
- Bipolar Disorder, Psycho-education
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual educationBehavioural
individual sessions of psycho-education
Group educationBehavioural
group psycho-education in 10 weekly sessions and then a session every third month for two years
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group education |
| individual education | Active comparator | Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education. Receives: Behavioral: individual education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on depression and mania rating scales
Measured: 12 months
Admissions to hospital
Measured: 24 months
Working activity
Measured: 24 months
Secondary outcomes (2)
Symptoms, function, use and change in medication, need for
Measured: 24 months
consultations
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159562
- Sponsor's protocol ID
- EW-2005
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2005
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27253214
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psycho-education of Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00159562
- Acronym / sponsor ID
- EW-2005
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Psycho-education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation
- Study start
- Sep 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group education | Experimental | Behavioral: Group educationBipolar 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. |
| individual education | Active comparator | Behavioral: individual educationBipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bipolar Disorder 1 or 2 Euthymic
Key exclusion criteria (1 listed)
- Active depression or mania/hypomania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual educationindividual sessions of psycho-education | Behavioural | individual education |
| Group educationgroup psycho-education in 10 weekly sessions and then a session every third month for two years | Behavioural | group education |
Primary outcome
Score on depression and mania rating scales
Time frame: 12 months
Admissions to hospital
Time frame: 24 months
Working activity
Time frame: 24 months
2 secondary outcomes
Symptoms, function, use and change in medication, need for
Time frame: 24 months
consultations
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Results publication: PubMed 27253214Kallestad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Morken, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual education and Group education in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on depression and mania rating scales (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.