Early Integrated Intervention in Severe Affective Disorders

Hovedstadens Sygehusfaelesskab

Status: Completed

Conditions: Bipolar Disorder; Depressive Disorder

Treatments: Behavioral: Prophylactic combined medical and psychological treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00253071

31/04r

Details and patient eligibility

About

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.

Full 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.

Enrollment: 426 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

A,2

Active Comparator group

Description:

Standard treatment: treatment as usual at a community psychiatric center, private psychiatrist or general practitioner.

Treatment:

Behavioral: Prophylactic combined medical and psychological treatment

A, 1

Experimental group

Description:

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.

Treatment:

Behavioral: Prophylactic combined medical and psychological treatment