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ISRCTN
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ISRCTN14404480
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ClinicalTrials.gov identifier
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Public title
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An evaluation of Motivational (MI) plus Cognitive Therapy (CBT) for Schizophrenia and Substance Misuse
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Scientific title
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Acronym
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Motivational Interventions for Drug and Alcohol Use in Schizophrenia (MIDAS)
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Serial number at source
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G0200471
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Study hypothesis
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The aim of the study is to evaluate the benefits of the adjunct of a psychological treatment over standard available care for patients with schizophrenia and a co-morbid drug or alcohol problem.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and behavioural disorder
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Participants - inclusion criteria
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1. Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM IV) diagnostic criteria for schizophrenia, schizophreniform or schizoaffective disorder
2. Recorded contact and treatment from mental health services at the point of recruitment
3. Prescribed anti-psychotic medication
4. Alcohol use exceeding 28 units for males, 21 units for females on at least half the weeks in the previous 3 months
5. DSM IV diagnosis of drug and/or alcohol dependence or abuse
6. No significant history of organic factors implicated in the aetiology of psychotic symptoms
7. English speaking
8. Informed patient consent
9. Having a fixed abode
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Participants - exclusion criteria
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See inclusion criteria
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Anticipated start date
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03/10/2004
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Anticipated end date
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02/05/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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The experimental treatment (MI plus CBT) will consist of motivational interviewing to increase motivation to reduce substance use; CBT for help with both substance use reduction and symptom management; and relapse prevention strategies. Patients randomised to receive MI plus CBT will be offered up to 26 sessions over 12 months with treatment being located at home or clinic according to the patient's choice. The MI plus CBT treatment will be in addition to standard psychiatric care. The control group will receive standard psychiatric care alone.
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Primary outcome measure(s)
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Either readmission to hospital for reason related to psychosis or death from any cause/not admitted to hospital in the 12 month post-treatment period.
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Secondary outcome measure(s)
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Added as of 6 February 2007: Measures of symtomatology, relapses, substance misuse and health economic analyses.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19362429
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Contact name
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Dr
Christine
Barrowclough
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Address
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Academic Division of Clinical Psychology
University of Manchester
School of Psychiatry and Behavioural Sciences
Education and Research Centre
Wythenshawe Hospital
Wythenshawe
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 5881
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Fax
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+44 (0)161 291 5882
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Email
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christine.barrowclough@man.ac.uk
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Sponsor
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University of Manchester (UK)
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Address
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Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Tel
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+44 (0)161 306 6000
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Email
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Sponsor website:
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http://www.manchester.ac.uk/
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Date applied
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29/08/2003
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Last edited
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03/08/2009
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Date ISRCTN assigned
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01/09/2003
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