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
| Autor: | Lars Vedel, Kessing, Hanne Vibe, Hansen, Ellen Margrethe, Christensen, Henrik, Dam, Christian, Gluud, Jørn, Wetterslev, Jens, Abraham |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Research design
medicine.medical_specialty Bipolar Disorder Psychological intervention Medicine (miscellaneous) Severity of Illness Index law.invention Study Protocol Randomized controlled trial law Intervention (counseling) Severity of illness medicine Humans Pharmacology (medical) Bipolar disorder Intensive care medicine Psychiatry Depressive Disorder lcsh:R5-920 business.industry medicine.disease Combined Modality Therapy Antidepressive Agents Psychotherapy Clinical trial Mood Research Design Sample Size business lcsh:Medicine (General) |
| Zdroj: | Trials, Vol 12, Iss 1, p 32 (2011) Trials |
| ISSN: | 1745-6215 |
| Popis: | Background In unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the diseases is not prevented with the present treatment modalities. It is not known whether centralised and specialised secondary care intervention initiated early after the onset of the diseases can prevent the progression and thereby improve the prognosis. Methods Two randomised clinical multi-centre trials comparing a centralised and specialised outpatient intervention program consisting of combined pharmacological and psychological intervention with standard decentralised psychiatric treatment. Patients discharged from their first, second, or third hospitalisation due to a manic episode or bipolar disorder (trial 1) or to a single depressive episode or recurrent depressive disorder (trial 2) were randomised. Central randomisations for both trials were stratified for the number of hospitalisations and treatment centre. The primary outcome measure for the two trials is time to re-hospitalisation with an affective episode. Discussion These trials are the first to evaluate the effect of a centralised and specialised intervention in patients with early severe affective disorders. The trials used a pragmatic design comparing a specialised mood disorder clinic intervention with decentralised, non-specialised standard psychiatric treatment. Trial Registration ClinicalTrials.gov: NCT00253071 |
| Databáze: | OpenAIRE |
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