Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G0701818
Study information
Scientific title
Assertive Community Treatment in Alcohol Dependence: a pilot randomised controlled trial
Acronym
ACTAD
Study hypothesis
As of 15/03/2010, this record has been substantially amended to include changes to the protocol; all changes can be found in the relevant field with the above update date. At this time, the target number of participants was increased from 88 to 132.
Assertive community treatment for chronic relapsing alcohol dependence results in better clinical outcomes than standard treatment and is more cost effective.
More details can be found at: http://www.iop.kcl.ac.uk/departments/?locator=1070
Ethics approval
Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, approved on 15/09/2008 (ref: 08/H0801/113)
Added 15/03/2010:
A substantial amendment was approved by the above ethics board on the 29th January 2010.
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Can be found at: http://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_1070_C2_PIS_08_H0801_113_SLAM_V2.doc
Condition
Alcohol dependency/ community alcohol services
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
12/01/2009
Overall trial end date
11/01/2012
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
88
Participant 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
Recruitment start date
12/01/2009
Recruitment end date
11/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Alcohol Research
London
SE5 8BB
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Prof John Strang
National Addiction Centre
PO Box 48
Division of Psycholigical Medicine & Psychiatry
4 Windsor Walk
London
SE5 8BB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK) (ref: G0701818)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
1. 2012 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22348423
Publication citations
-
Study protocol
Gilburt H, Burns T, Copello A, Coulton S, Crawford M, Day E, Deluca P, Godfrey C, Parrott S, Rose AK, Sinclair JM, Wright C, Drummond C, Assertive Community Treatment for alcohol dependence (ACTAD): study protocol for a randomised controlled trial., Trials, 2012, 13, 19, doi: 10.1186/1745-6215-13-19.