Early Integrated Intervention in Severe Affective Disorders

Not Applicable

Completed

• Conditions: Bipolar Disorder; Depressive Disorder
• Interventions: Behavioral: Prophylactic combined medical and psychological treatment

• Registration Number: NCT00253071
• Lead Sponsor: Hovedstadens Sygehusfaelesskab

Brief Summary

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

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 Timeline

• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Start: 2005-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

1. Discharge diagnosis of severe single depressive episode, recurrent depression, manic/mixed episode or bipolar disorder

Exclusion Criteria

1. Moderate to severe dementia
2. Incapable in understanding or reading danish
3. Earlier randomised to the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,2	Prophylactic combined medical and psychological treatment	Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.
A, 1	Prophylactic combined medical and psychological treatment	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.

Primary Outcome Measures

Name	Time	Method
Time to re-admission	0-6 years

Secondary Outcome Measures

Name	Time	Method
Time to recurrence of an affective episode (depressive (MDI) or manic/mixed (MDQ)).	1 and 2 years

Trial Locations

Locations (1)

Department of Psychiatry, University Hospital of Copenhagen, Denmark; 🇩🇰 Copenhagen, Denmark