Early Integrated Intervention in Severe Affective Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Integrated Intervention in Severe Affective Disorders - a Randomized Controlled Trial.

Conditions
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Depressive Disorder, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Prophylactic combined medical and psychological treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A,2<br>Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner. | Behavioral: Prophylactic combined medical and psychological treatment<br>* Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.<br>|
| Experimental: A, 1<br>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. | Behavioral: Prophylactic combined medical and psychological treatment<br>* Medical treatment is naturalistic and evidence based according to international recommendations. Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to re-admission |  | 0-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)). |  | 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylactic treatment, Pharmacological treatment, Psychological treatment