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Mentalisation-Based Treatment for Dual Diagnoses

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98982683
Enrollment
80
Registered
2009-05-08
Start date
2009-05-13
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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) Mental and Behavioural Disorders

Interventions

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

Sponsors

Stockholm County Council (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026