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An evaluation of Motivational (MI) plus Cognitive Therapy (CBT) for Schizophrenia and Substance Misuse
ISRCTN ISRCTN14404480
DOI 10.1186/ISRCTN14404480
ClinicalTrials.gov identifier
EudraCT number
Public title An evaluation of Motivational (MI) plus Cognitive Therapy (CBT) for Schizophrenia and Substance Misuse
Scientific title
Acronym Motivational Interventions for Drug and Alcohol Use in Schizophrenia (MIDAS)
Serial number at source G0200471
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental and behavioural disorder
Participants - inclusion criteria 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
Participants - exclusion criteria See inclusion criteria
Anticipated start date 03/10/2004
Anticipated end date 02/05/2009
Status of trial Completed
Patient information material
Target number of participants 400
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) Added as of 6 February 2007: Measures of symtomatology, relapses, substance misuse and health economic analyses.
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19362429
Contact name Dr  Christine  Barrowclough
  Address Academic Division of Clinical Psychology
University of Manchester
School of Psychiatry and Behavioural Sciences
Education and Research Centre
Wythenshawe Hospital
Wythenshawe
  City/town Manchester
  Zip/Postcode M23 9LT
  Country United Kingdom
  Tel +44 (0)161 291 5881
  Fax +44 (0)161 291 5882
  Email christine.barrowclough@man.ac.uk
Sponsor University of Manchester (UK)
  Address Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 306 6000
  Email
  Sponsor website: http://www.manchester.ac.uk/
Date applied 29/08/2003
Last edited 03/08/2009
Date ISRCTN assigned 01/09/2003
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