Mentalisation-Based Treatment for Dual Diagnoses
| ISRCTN | ISRCTN98982683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98982683 |
| Secondary identifying numbers | N/A |
- 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
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 |
| bjorn.philips@ki.se |
Study information
| Study design | Randomised parallel-group rater-blinded clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (in Swedish) |
| 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 | 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 study start date | 01/04/2009 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2 x 40 patients |
| 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
Box 17914
Stockholm
SE-11895
Sweden
Sponsor information
Stockholm County Council (Sweden)
Government
Government
c/o Johan Franck
Center for Dependency Disorders
Folkungagatan 44
Stockholm
SE-11895
Sweden
| Website | http://www.beroendecentrum.se |
|---|---|
"ROR" |
https://ror.org/02zrae794 |
Funders
Funder type
Government
Swedish Council for Working Life and Social Research (Sweden) (ref: 2007-0457)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Swedish Council for Working Life and Social Research, FAS
- Location
- Sweden
Stockholms Läns Landsting
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Stockholm County Council
- Location
- Sweden
Karolinska Institutet
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date |
| 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 |
Editorial Notes
01/09/2020: Publication reference and total final enrolment number added.
