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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Amager Hospital | OTHER |
| Frederiksberg University Hospital |
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The purpose of this study is to determine whether early integrated prophylactic combined medical and psychological outpatient treatment is associated with a better prognosis in patients with severe unipolar and bipolar affective disorders than standard treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A,2 | Active Comparator | Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner. |
|
| A, 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic combined medical and psychological treatment | Behavioral | Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to re-admission | 0-6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). | 1 and 2 years |
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Inclusion Criteria:
1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars V kessing, Professor | Department of psychiatry, University Hospital of Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, University Hospital of Copenhagen, Denmark | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38825333 | Derived | Munkholm K, Kessing LV. Early specialised treatment for bipolar disorder: Long-term follow-up from the early intervention in affective disorders (EIA) randomised controlled trial. Acta Psychiatr Scand. 2024 Sep;150(3):138-147. doi: 10.1111/acps.13716. Epub 2024 Jun 2. | |
| 24268595 | Derived | 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. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| OTHER |
| Bispebjerg Hospital | OTHER |
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| 23349295 | Derived | 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. |
| 22442673 | Derived | 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. |
| 21291564 | Derived | 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. |