An evaluation of Motivational (MI) plus Cognitive Therapy (CBT) for Schizophrenia and Substance Misuse
| ISRCTN | ISRCTN14404480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14404480 |
| Secondary identifying numbers | G0200471 |
- Submission date
- 29/08/2003
- Registration date
- 01/09/2003
- Last edited
- 03/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Christine Barrowclough
Scientific
Scientific
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
| Phone | +44 (0)161 291 5881 |
|---|---|
| christine.barrowclough@man.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Primary outcome measure | 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 study start date | 03/10/2004 |
| Overall study end date | 02/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 |
| 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 exclusion criteria | See inclusion criteria |
| Recruitment start date | 03/10/2004 |
| Recruitment end date | 02/05/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Division of Clinical Psychology
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 306 6000 |
|---|---|
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No |
