ISRCTN ISRCTN67266318
DOI https://doi.org/10.1186/ISRCTN67266318
Secondary identifying numbers 438155 ILC
Submission date
17/07/2012
Registration date
15/10/2012
Last edited
13/06/2022
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

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 over 17, 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 receive the best standard of care at their local substance abuse treatment unit. The other half 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 is decided by a process called ‘randomisation’, which is like a coin toss. Three months after this, all participants are 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?
March 2012 to July 2013

Who is funding the study?
1. Reckitt Benckiser (Denmark)
2. University of Aarhus (Denmark)

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

Contact information

Mr Morten Hesse
Scientific

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

Study information

Study designMultisite open randomized trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe efficacy of the Impulsive Lifestyle Counselling as an addition to standard substance abuse treatment
Study acronymILC
Study hypothesisThe Impulsive Lifestyle Counselling will reduce aggression and drug use in outpatients with substance use disorders.
Ethics approval(s)Institutional Review Board, Denmark
ConditionAntisocial personality disorder
InterventionTreatment 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 typeOther
Primary outcome measure1. Aggression, measured using the Buss-Perry Aggresion Questionnaire and Self-Report of Aggression and Social Behavior Measure
2. Drug use, measured using the Addiction Severity Index Composite score and Percent days abstinent
Secondary outcome measures1. Perceived help for antisocial personality disorder
2. Readiness to change antisocial behaviour, measured using the adapted readiness ruler
3. Staff-rated improvement in in-clinic antisocial behaviour, general antisocial behaviour, and substance use
Overall study start date01/03/2012
Overall study end date01/07/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Participant inclusion criteria1. Antisocial personality disorder according to the MINI International Neuropsychiatric Interview
2. Seeking treatment for a substance use disorder
Participant exclusion criteria1. 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 date01/03/2012
Recruitment end date01/07/2013

Locations

Countries of recruitment

  • Denmark

Study participating centre

University of Aarhus
Copenhagen
2300
Denmark

Sponsor information

Reckitt Benckiser Pharmaceuticals (UK)
Industry

103-105 Bath Road
Slough
SL1 3UH
United Kingdom

Website http://www.reckittbenckiser.com
ROR logo "ROR" https://ror.org/01g87hr29

Funders

Funder type

Industry

Reckitt Benckiser (Denmark)

No information available

Aarhus Universitet
Government organisation / Universities (academic only)
Alternative name(s)
Aarhus University, Universitas Arhusiensis, AU
Location
Denmark

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/11/2015 Yes No
Other publications post-hoc secondary analysis 09/01/2017 Yes No
Results article 10/06/2022 13/06/2022 Yes No

Editorial Notes

13/06/2022: Publication reference added.
11/01/2017: Publication reference added.