Early Integrated Intervention in Severe Affective Disorders
Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who have been hospitalised for unipolar or bipolar disorder have a poor prognosis with highly increased risk of recurrence of episodes and increased risk of psychosocial dysfunction. It seems as integrated prophylactic combined medical and psychological out-patient treatment may lead to a better long-term prognosis in patients with affective disorders in general. It has not been specifically investigated whether such integrated treatment may improve long-term outcome if the intervention is offered early in the course of the affective illness.
Subjects: Patients currently discharged from first, second or third hospitalisation ever from psychiatric department with a diagnosis of severe single depressive episode/recurrent depression or with a diagnosis of manic/mixed episode or bipolar disorder.
Comparison: Early intervention with integrated prophylactic combined medical and psychological outpatient treatment as offered by a clinic for affective disorders compared with standard outpatient treatment as offered by community psychiatric centres, private specialists in psychiatry or general practitioners.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Department of Psychiatry, University Hospital of Copenhagen, Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder
Exclusion Criteria:
- Moderate to severe dementia
- Incapable in understanding or reading danish
- Earlier randomised to the trial
Study Plan
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 |
|---|---|
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Active Comparator: A,2
Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.
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Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy. |
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Experimental: A, 1
Behavioral: Prophylactic combined medical and psychological treatment Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy. |
Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time to re-admission
Time Frame: 0-6 years
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0-6 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).
Time Frame: 1 and 2 years
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1 and 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars V kessing, Professor, Department of Psychiatry, University Hospital of Copenhagen, Denmark
Publications and helpful links
General Publications
- Kessing LV, Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Trial Group. Do young adults with bipolar disorder benefit from early intervention? J Affect Disord. 2014 Jan;152-154:403-8. doi: 10.1016/j.jad.2013.10.001. Epub 2013 Oct 10.
- Kessing LV, Hansen HV, Hvenegaard A, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Trial Group. Treatment in a specialised out-patient mood disorder clinic v. standard out-patient treatment in the early course of bipolar disorder: randomised clinical trial. Br J Psychiatry. 2013 Mar;202(3):212-9. doi: 10.1192/bjp.bp.112.113548. Epub 2013 Jan 24.
- Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J, Kessing LV; Early Intervention Affective Disorders (EIA) Trial Group. The effects of centralised and specialised intervention in the early course of severe unipolar depressive disorder: a randomised clinical trial. PLoS One. 2012;7(3):e32950. doi: 10.1371/journal.pone.0032950. Epub 2012 Mar 19.
- Kessing LV, Hansen HV, Christensen EM, Dam H, Gluud C, Wetterslev J; Early Intervention Affective Disorders (EIA) Group. The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders--design of two randomised clinical trials. Trials. 2011 Feb 3;12:32. doi: 10.1186/1745-6215-12-32.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31/04r
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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