Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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15 January 2018 |
Main ID: |
ISRCTN22775534 |
Date of registration:
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27/03/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pilot study of Assertive Community Treatment in Alcohol Dependence
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Scientific title:
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Assertive Community Treatment in Alcohol Dependence: a pilot randomised controlled trial |
Date of first enrolment:
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12/01/2009 |
Target sample size:
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88 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN22775534 |
Study type:
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Interventional |
Study design:
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Pilot randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Colin
Drummond |
Address:
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Section of Alcohol Research
National Addiction Centre
PO Box 48
Department of Addictions
4 Windsor Walk
SE5 8BB
London
United Kingdom |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Current inclusion criteria as of 15/03/2010: 1. Both males and females, adult patients (greater than or equal to 18 years) 2. One or more previous episodes of treatment for alcohol dependence in the last 5 years in community drug and alcohol services 3. Alcohol dependent (as determined by Composite International Diagnostic Interview- Short Form [CIDI-SF])
Initial information at time of registration: 1. Both males and females, adult patients (greater than or equal to 18 years) 2. Severe alcohol dependence (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV] and Severity of Alcohol Dependence Questionnaire Score greater than or equal to 30) 3. History of premature disengagement from alcohol services (one or more previous episodes of non-completion of treatment) 4. Patients with potentially more complex needs (e.g., lack of social support, unstable housing, physical illness, depression, legal problems)
Exclusion criteria: Current exclusion criteria as of 15/03/2010: 1. Attended a professional service for alcohol dependence in the last 6 months 2. Street homeless 3. Diagnosed with a psychotic disorder 4. Is in receipt of assertive outreach services, or has Community Mental Health Team (CMHT) input greater than or equal to once a month 5. Has a severe cognitive impairment 6. Has a history of violence to treatment staff and/or Multi-Agency Public Protection Arrangements (MAPPA) registered
Initial information at time of registration: 1. Patients with concurrent severe mental illness 2. Patients with severe cognitive impairment 3. Patients already in receipt of assertive treatment services
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alcohol dependency/ community alcohol services Mental and Behavioural Disorders Mental and behavioural disorders due to use of alcohol
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Intervention(s)
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Current interventions as of 15/03/2010: Participants will be individually randomised to the following two arms (randomisation ration 2:1).
Arm 1: Control condition, standard treatment comprising: 1. An assigned keyworker (caseload greater than 25) 2. Care plan 3. Psychological interventions as necessary 4. Pharmacotherapies 5. Inpatient treatment 6. Referral to, and liaison with, other agencies) 7. Duration of care less than or equal to 3 months
Arm 2: Assertive Community Treatment, including standard treatment plus: 1. Rapid access to services 2. Staff with a small caseload (less than or equal to 15) 3. A high ratio of in vivo to office-based appointments 4. Assertive engagement 5. Focus of care extended beyond alcohol dependence 6. A shared care approach 7. Care coordinators working within a multidisciplinary team that meets frequently 8. Extended contact with patients over 12 months
Initial information at time of registration: Participants will be individually randomised to the following two arms (randomisation ratio 1:1):
Control condition, standard treatment comprising: a. An assigned keyworker (caseload >25) b. Care plan c. Psychological interventions as necessary d. Pharmacotherapies e. Inpatient treatment f. Referral to, and liaison with, other agencies
Assertive Community Treatment, including standard treatment plus: a. Rapid access to services b. A small caseload (<=15) c. A high ratio of 'in vivo' to office based appointments d. Extensive motivational interviewing e. Assertive coordinators working within a multidisciplinary team that meets frequently f. Extended contact with patients over 12 months
The interventions will be running for 26 months of the trial. The length of the interventions for each patient will be 12 months.
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Primary Outcome(s)
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Alcohol consumption assessed using the Time Follow Back Interview (Form 90) to provide a measure of mean drinks per drinking day and percent days abstinent. This will be assessed at baseline (receipt of referral by community alcohol team), at 6 months and 12 months follow up.
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Secondary Outcome(s)
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1. Severity of Alcohol Dependence Questionnaire, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 2. Alcohol Problems Questionnaire, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 3. Motivation, assessed by the Readiness to Change Questionnaire, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 4. Social Network Involvement, assessed by the Important People and Activities Inventory, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 5. Psychiatric symptoms, assessed by the SF-12® Health Survey, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 6. Quality of Life, assessed by Euroqol EQ-5D, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 7. Therapeutic relationships, assessed by the Scale To Assess Relationships in community mental health care (STAR), assessed during the 6 month and 12 month follow up interviews 8. Service User Questionnaire, assessed at baseline (receipt of referral by community alcohol team), 6 months and 12 months follow up 9. Treatment engagement, including completion of assessment, detoxification and aftercare, assessed during the 6 month and 12 month follow up interviews
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Secondary ID(s)
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MRC ref: G0701818
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Source(s) of Monetary Support
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Medical Research Council (UK) (ref: G0701818)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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