Condition category
Mental and Behavioural Disorders
Date applied
21/01/2009
Date assigned
27/03/2009
Last edited
23/02/2012
Prospective/Retrospective
Retrospectively 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

Prof Colin Drummond

ORCID ID

Contact details

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

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

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (UK) (ref: G0701818)

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

1. 2012 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22348423

Publication citations

  1. 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.

Additional files

Editorial Notes