Mentalisation-Based Treatment for Dual Diagnoses

ISRCTN	ISRCTN98982683
DOI	https://doi.org/10.1186/ISRCTN98982683
Protocol serial number	N/A
Sponsor	Stockholm County Council (Sweden)
Funders	Swedish Council for Working Life and Social Research (Sweden) (ref: 2007-0457), Stockholms Läns Landsting, Karolinska Institutet

Submission date: 26/03/2009
Registration date: 08/05/2009
Last edited: 01/09/2020

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 of protocol

Not provided at time of registration

Contact information

Dr Björn Philips
Scientific

Stockholm County Council
Center for Dependency Disorders
S:t Göransgatan 126, level 5
Stockholm
SE-11245
Sweden

ORCID ID	0000-0003-4313-1011
Phone	+46 (0)8 672 25 52
Email	bjorn.philips@ki.se

Study information

Primary study design	Interventional
Study design	Randomised parallel-group rater-blinded clinical trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Mentalisation-Based Treatment for Dual Diagnoses: a randomised controlled trial
Study acronym	MBTDD
Study objectives	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(s)	Regional Ethical Review Board in Stockholm, 13/06/2007, ref: 2007/642-31/1
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Total final enrolment	46
Key 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
Key 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
Date of first enrolment	13/05/2009
Date of final enrolment	20/12/2013

Locations

Countries of recruitment

Sweden

Study participating centre

Center for Dependency Disorders

Stockholm County Council
Box 17914
Stockholm
SE-11895
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2018	01/09/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/09/2020: Publication reference and total final enrolment number added.