Condition category
Mental and Behavioural Disorders
Date applied
29/08/2003
Date assigned
01/09/2003
Last edited
03/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christine Barrowclough

ORCID ID

Contact details

Academic Division of Clinical Psychology
University of Manchester
School of Psychiatry and Behavioural Sciences
Education and Research Centre
Wythenshawe Hospital
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5881
christine.barrowclough@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0200471

Study information

Scientific title

Acronym

Motivational Interventions for Drug and Alcohol Use in Schizophrenia (MIDAS)

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and behavioural disorder

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Added as of 6 February 2007: Measures of symtomatology, relapses, substance misuse and health economic analyses.

Overall trial start date

03/10/2004

Overall trial end date

02/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

See inclusion criteria

Recruitment start date

03/10/2004

Recruitment end date

02/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Division of Clinical Psychology
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 6000

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19362429

Publication citations

  1. Results

    Barrowclough C, Haddock G, Beardmore R, Conrod P, Craig T, Davies L, Dunn G, Lewis S, Moring J, Tarrier N, Wykes T, Evaluating integrated MI and CBT for people with psychosis and substance misuse: recruitment, retention and sample characteristics of the MIDAS trial., Addict Behav, 2009, 34, 10, 859-866, doi: 10.1016/j.addbeh.2009.03.007.

Additional files

Editorial Notes