Condition category
Mental and Behavioural Disorders
Date applied
10/05/2007
Date assigned
11/01/2008
Last edited
11/04/2008
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 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

http://www.helsefonden.dk/

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

Publication citations

Additional files

Editorial Notes