Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Mr Morten Hesse


Contact details

Center for Alcohol and Drug Research
University of Aarhus
Artillerivej 90

Additional identifiers

EudraCT number 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



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


Secondary study design

Randomised controlled trial

Trial setting


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


Antisocial personality disorder


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



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

University of Aarhus

Sponsor information


Reckitt Benckiser Pharmaceuticals (UK)

Sponsor details

103-105 Bath Road
United Kingdom

Sponsor type




Funder type


Funder name

Reckitt Benckiser (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Aarhus University (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:

Publication citations

Additional files

Editorial Notes