Condition category
Mental and Behavioural Disorders
Date applied
17/07/2012
Date assigned
15/10/2012
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some people who abuse alcohol or other drugs also have persistent problems with impulsive behaviour, crime and aggression. This is called an antisocial personality disorder. There is currently no specialized help for people with these problems in outpatient substance abuse treatment services.

Who can participate?
Men and women, aged more than 17 years, who have attended substance abuse treatment services in Denmark.

What does the study involve?
The study involves a brief interview and the completion of a questionnaire. After this, half the participants will receive the best standard of care at their local substance abuse treatment unit. The other half will receive the same care plus six sessions of counselling and information about impulsive and aggressive behaviour. The treatment to which a participant is allocated to will be decided by a process called ‘randomisation’, which is like a coin toss. Three months after this, all participants will be invited to an interview about their current situation and the treatment they have received.

What are the possible benefits and risks of participating?
There are no immediate benefits to participating. If the counselling program turns out to be helpful, participation may help future patients receive a better standard of care. The same standard of care applies to all patients whether or not they choose to participate, and they can withdraw from the study at any time.

Where is the study run from?
University of Aarhus (Denmark).

When is the study starting and how long is it expected to run for?
Recruitment started in March 2012. Participants will be recruited to the study for two years.

Who is funding the study?
University of Aarhus and RB Pharmaceuticals.

Who is the main contact?
Associate Professor Morten Hesse
mh@crf.au.dk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Morten Hesse

ORCID ID

Contact details

Center for Alcohol and Drug Research
University of Aarhus
Artillerivej 90
2nd
Copenhagen
2300
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

438155 ILC

Study information

Scientific title

The efficacy of the Impulsive Lifestyle Counselling as an addition to standard substance abuse treatment

Acronym

ILC

Study hypothesis

The Impulsive Lifestyle Counselling will reduce aggression and drug use in outpatients with substance use disorders

Ethics approval

Institutional Review Board, Denmark

Study design

Multisite open randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Antisocial personality disorder

Intervention

Treatment as usual (TAU):
All participants in the control group receive treatment as usual, i.e. whatever treatment they would have received if the trial had not been taking place. Treatment as usual include casework, whatever counseling models each of the participating clinics provide, opioid substitution treatment, referral to psychiatric treatment as needed.

Experimental treatment:
Patients in the experimental condition receive treatment as usual, and are additionally offered a 6-session therapy based on the Lifestyle Issues program developed by Glenn D. Walters. In line with the Criminal Lifestyle Theory, the ILC program is presented as an approach to change the client’s life.
All six sessions take one hour. The first 5 sessions focus on separate issues: session 1 focuses on educating the client about the treatment approach, increasing awareness of problems associated with an impulsive lifestyle, and identifying client goals. Session 2 uses a problem-solving approach to identify concrete difficult situations that the client encounters in daily life. Session 3 focuses on “streetwise pride” and client experiences of self-esteem based on streetwise pride. Session 4 addresses pro-social and antisocial values, session 5 focuses on social networks and their push or pull effect regarding change of lifestyle, and session 6 is a booster session which takes place 6 weeks after session 5. Here the client is invited to discuss the issues that have come up in previous sessions. All sessions are described in a detailed manual with pre-printed handouts and pre-printed homework assignments.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Aggression (Buss-Perry Aggresion Questionnaire and Self-Report of Aggression and Social Behavior Measure)
2. Drug use (Addiction Severity Index Composite score and Percent days abstinent)

Secondary outcome measures

1. Perceived help for antisocial personality disorder
2. Readiness to change antisocial behaviour (Adapted readiness ruler)
3. Staff-rated improvement in in-clinic antisocial behaviour, general antisocial behaviour, and substance use.

Overall trial start date

01/03/2012

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Antisocial personality disorder according to the MINI International Neuropsychiatric Interview
2. Seeking treatment for a substance use disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Psychosis
2. Not able to speak Danish
3. Wil not giving consent
4. Plans to relocate
5. Serving in prison or due to go into residential rehabilitation over the next three months.

Recruitment start date

01/03/2012

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Denmark

Trial participating centre

University of Aarhus
Copenhagen
2300
Denmark

Sponsor information

Organisation

Reckitt Benckiser Pharmaceuticals (UK)

Sponsor details

103-105 Bath Road
Slough
SL1 3UH
United Kingdom

Sponsor type

Industry

Website

http://www.reckittbenckiser.com

Funders

Funder type

Industry

Funder name

Reckitt Benckiser (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aarhus University (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26573140

Publication citations

Additional files

Editorial Notes