Contact information
Type
Scientific
Primary contact
Prof Morten Hesse
ORCID ID
Contact details
Aarhus University
Centre for Alcohol and Drug Research
Købmagergade 26E
Copenhagen
1150
Denmark
+45 33 32 73 00
mortenhesse@crf.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
That adjusting referral and case-work through structured feedback and ongoing supervision to personality disorders will lead to improved outcomes in substance abuse treatment.
Ethics approval
Institutional Review Boards in Denmark do not approve or disapprove of trials or other studies of psychosocial interventions. The medical director of social medicine in the City of Copenhagen, M.D. Peter Ege, read and approved the protocol. Patients will be given full information about the nature of the study, and be asked to give informed consent. Patients who refuse participation in the study will be given full access to all regular treatment services in the organisation, similar to the control group.
Study design
A randomised controlled trial with patients being randomised at admission to treatment. Assessors will be blind to randomisation.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Substance use disorders and personality disorders
Intervention
Experimental condition:
Referral and case management, plus personality disorder feedback and active tailoring of referral and planning to adjust for personality disorder severity.
Control condition:
Referral and case management alone, with assessment of Attention-Deficit Hyperactivity Disorder (ADHD) (ADHD Self-Report Scale [ASRS]), anxiety/depression (Kessler 6).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
At 3 and 6 months follow-up:
1. Substance use (measured with the Opiate Treatment Index)
2. Social functioning (measured with the Work and Social Adjustment Scale)
3. Symptoms of anxiety or depression (measured with the Kessler 6)
4. Completion of planned treatment
Secondary outcome measures
Satisfaction with treatment.
Overall trial start date
01/11/2007
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 18 - 70 years
2. With substance use disorders and co-morbid personality disorder seeking treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Acute psychotic disorders
2. Severe neurological condition
Recruitment start date
01/11/2007
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Denmark
Trial participating centre
Aarhus University
Copenhagen
1150
Denmark
Sponsor information
Organisation
The Health Insurance Foundation (Denmark)
Sponsor details
Sygekassernes Helsefond
Magstræde 6
1. sal
Copenhagen
1204
Denmark
+45 33 93 40 77
hesse@medscape.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Health Insurance Foundation (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