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Early Integrated Intervention in Severe Affective Disorders

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00253071
Enrollment
426
Registered
2005-11-15
Start date
2005-12-31
Completion date
2012-03-31
Last updated
2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depressive Disorder

Keywords

Prophylactic treatment, Pharmacological treatment, Psychological treatment

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.

Interventions

BEHAVIORALProphylactic 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.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Amager Hospital
CollaboratorOTHER
Frederiksberg University Hospital
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Hovedstadens Sygehusfaelesskab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to re-admission0-6 years

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026