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

Lars Vedel Kessing; Hanne Vibe Hansen; Ellen Margrethe Christensen; Henrik Friis Dam; Christian Nyfeldt Gluud; Jørn Wetterslev; Early Intervention Affective Disorders (EIA) Group

doi:http://dx.doi.org/10.1186/1745-6215-12-32

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

Lars Vedel Kessing, Hanne Vibe Hansen, Ellen Margrethe Christensen, Henrik Friis Dam, Christian Nyfeldt Gluud, Jørn Wetterslev, Early Intervention Affective Disorders (EIA) Group

5 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Trials
Volume	12
Issue number	1
Pages (from-to)	32
ISSN	1745-6215
DOIs	https://doi.org/10.1186/1745-6215-12-32
Publication status	Published - 3 Feb 2011

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Kessing, L. V., Hansen, H. V., Christensen, E. M., Dam, H. F., Gluud, C. N., Wetterslev, J., & Early Intervention Affective Disorders (EIA) Group (2011). 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. Trials, 12(1), 32. https://doi.org/10.1186/1745-6215-12-32

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. / Kessing, Lars Vedel; Hansen, Hanne Vibe; Christensen, Ellen Margrethe et al.

In: Trials, Vol. 12, No. 1, 03.02.2011, p. 32.

Research output: Contribution to journal › Journal article › Research › peer-review

Kessing, LV, Hansen, HV, Christensen, EM, Dam, HF, Gluud, CN, Wetterslev, J & Early Intervention Affective Disorders (EIA) Group 2011, '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', Trials, vol. 12, no. 1, pp. 32. https://doi.org/10.1186/1745-6215-12-32

Kessing LV, Hansen HV, Christensen EM, Dam HF, Gluud CN, Wetterslev J et al. 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. Trials. 2011 Feb 3;12(1):32. doi: http://dx.doi.org/10.1186/1745-6215-12-32

Kessing, Lars Vedel ; Hansen, Hanne Vibe ; Christensen, Ellen Margrethe et al. / 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. In: Trials. 2011 ; Vol. 12, No. 1. pp. 32.

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title = "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",

abstract = "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.",

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AU - Kessing, Lars Vedel

AU - Hansen, Hanne Vibe

AU - Christensen, Ellen Margrethe

AU - Dam, Henrik Friis

AU - Gluud, Christian Nyfeldt

AU - Wetterslev, Jørn

AU - Early Intervention Affective Disorders (EIA) Group

PY - 2011/2/3

Y1 - 2011/2/3

N2 - 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.

AB - 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.

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