Pilot study of Assertive Community Treatment in Alcohol Dependence

ISRCTN	ISRCTN22775534
DOI	https://doi.org/10.1186/ISRCTN22775534
Secondary identifying numbers	MRC ref: G0701818

Submission date: 21/01/2009
Registration date: 27/03/2009
Last edited: 19/12/2017

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 of protocol

Not provided at time of registration

Contact information

Prof Colin Drummond
Scientific

Section of Alcohol Research
National Addiction Centre
PO Box 48
Department of Addictions
4 Windsor Walk
London
SE5 8BB
United Kingdom

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant 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
Scientific title	Assertive Community Treatment in Alcohol Dependence: a pilot randomised controlled trial
Study acronym	ACTAD
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	12/01/2009
Completion date	11/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	88
Key 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)
Key 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
Date of first enrolment	12/01/2009
Date of final enrolment	11/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Section of Alcohol Research

London
SE5 8BB
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Prof John Strang
National Addiction Centre
PO Box 48
Division of Psycholigical Medicine & Psychiatry
4 Windsor Walk
London
SE5 8BB
England
United Kingdom

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

Medical Research Council (UK) (ref: G0701818)
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?
Protocol article	protocol	20/02/2012		Yes	No
Results article	results	09/03/2017		Yes	No

Editorial Notes

19/12/2017: Publication reference added.