Condition category
Mental and Behavioural Disorders
Date applied
26/03/2009
Date assigned
08/05/2009
Last edited
16/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.beroendecentrum.se

Contact information

Type

Scientific

Primary contact

Dr Björn Philips

ORCID ID

http://orcid.org/0000-0003-4313-1011

Contact details

Stockholm County Council
Center for Dependency Disorders
S:t Göransgatan 126
level 5
Stockholm
SE-11245
Sweden
+46 (0)8 672 25 52
bjorn.philips@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Mentalisation-Based Treatment for Dual Diagnoses: a randomised controlled trial

Acronym

MBTDD

Study hypothesis

Current hypothesis as of 10/12/2014:
The main hypothesis is that mentalisation-based treatment (MBT) as a complement to standard dependency care is a more efficacious treatment than standard dependency care alone in patients with borderline personality disorder and concomitant substance dependence.

Previous hypothesis:
The main hypothesis is that mentalisation-based treatment (MBT) as a complement to medication assisted treatment (MAT) for opiate dependence is a more efficacious treatment than current practice (MAT for opiate addiction alone) in patients with borderline personality disorder and concomitant opiate dependence.

On 10/12/2014 the overall trial end date was changed from 01/04/2012 to 30/06/2015.

Ethics approval

Regional Ethical Review Board in Stockholm, 13/06/2007, ref: 2007/642-31/1

Study design

Randomised parallel-group rater-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Current condition as of 10/12/2014:
Borderline personality disorder with substance dependence (dependence on alcohol, amphetamines, cannabis, cocaine, hallucinogens, opioids, phencyclidine, sedatives/hypnotics/anxiolytics, or poly-substance – present or in remission)

Previous condition:
Borderline personality disorder with opiate dependence (present or in remission)

Intervention

Current interventions as of 10/12/2014:
Intervention group:
Mentalisation-based treatment (MBT) as a complement to standard dependency care. MBT in accordance to manual consists of mentalising focus work in an individual session and a group session once per week. The duration of treatment is 18 months. Therapists' adherence and competence will be examined based on video-taped therapy sessions.

Control group:
Standard dependency care.

Previous interventions:
Intervention group:
Mentalisation-based treatment (MBT) as a complement to medication-assisted treatment (MAT) for opiate dependence. MBT in accordance to manual consists of mentalising focus work in an individual session and a group session once per week. The duration of treatment is 18 months. Therapists' adherence and competence will be examined based on video-taped therapy sessions.

Control group:
Medication assisted treatment (MAT) for opiate dependence alone.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The Borderline Personality Disorder Severity Index, 4th Edition (BPDSI-IV).

The main effect concerns change from baseline to termination of treatment (18 months). Intent-to-treat analysis by last observation carried forward will be used and the statistical analysis will be ANOVA with repeated measures.

Secondary outcome measures

1. Timeline Follow Back and specimens of urine for use of opiates, alcohol and other drugs
2. Beck's Suicidal Intent Scale (SIS)
3. Deliberate Self-Harm Inventory (DSHI-9)
4. Global Assessment of Functioning (GAF)
5. Symptom Check List 90 (SCL-90)
6. Inventory of Interpersonal Problems (IIP), short version
7. Social Adjustment Scale - Self Report (SAS-SR)
8. Retention in treatment
9. Reflective Functioning Interview (for mediator analysis)

The measures are used at baseline and at 6-monthly intervals until the end of treatment. Follow up: 6 and 18-months after endpoint.

Long-term follow up from register data:
10. Health economy (health care utilisation and work/income)
11. Criminality
12. Survival

Overall trial start date

01/04/2009

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 10/12/2014:
Participant inclusion criteria
1. Aged 18 - 65 years, either sex
2. Provide written informed consent to participate in the study
3. Address and telephone number in Stockholm County where the patient can be reached
4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for borderline personality disorder
5. Meet DSM-IV criteria for substance dependence (dependence on alcohol, amphetamines, cannabis, cocaine, hallucinogens, opioids, phencyclidine, sedatives/hypnotics/anxiolytics, or poly-substance – present or in remission)
6. Ongoing dependency care at a dependency care outpatient unit (for patients with opiate dependence, ongoing pharmacological treatment with buprenorphine or methadone for at least 3 months)

Previous inclusion criteria:
1. Aged 18 - 65 years, either sex
2. Provide written informed consent to participate in the study
3. Address and telephone number in Stockholm County where the patient can be reached
4. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for borderline personality disorder
5. Meet DSM-IV criteria for opiate dependence (present or in remission)
6. Ongoing pharmacological treatment with buprenorphine or methadone for at least 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2 x 40 patients

Participant exclusion criteria

1. Meet DSM-IV criteria for schizophrenia, schizoaffective disorder or bipolar I disorder, (other psychotic or mood disorders do not constitute exclusion criteria)
2. Mental retardation or borderline intellectual functioning (intelligence quotient [IQ] less than 85)
3. Autistic disorder or Aspergers disorder
4. Psychopathy according to Psychopathy Checklist: Screening Version (PCL-SV)
5. Psychotherapy outside the research project, which is ongoing or terminated less than three months ago

Added 10/12/2014:
6. Not able to communicate in Swedish without help from an interpreter

Recruitment start date

13/05/2009

Recruitment end date

20/12/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

Center for Dependency Disorders
Stockholm County Council Box 17914
Stockholm
SE-11895
Sweden

Sponsor information

Organisation

Stockholm County Council (Sweden)

Sponsor details

c/o Johan Franck
Center for Dependency Disorders
Folkungagatan 44
Stockholm
SE-11895
Sweden

Sponsor type

Government

Website

http://www.beroendecentrum.se

Funders

Funder type

Government

Funder name

Swedish Council for Working Life and Social Research (Sweden) (ref: 2007-0457)

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

Funder name

Stockholms Läns Landsting

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Karolinska Institutet

Alternative name(s)

Karolinska Institute, KI

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes