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Are there indications for the effectiveness of Schema Therapy for patients suffering from borderline personality disorder and alcohol dependency?


- candidate number22353
- NTR NumberNTR5218
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2015
- Secondary IDs2014-CP-3813 
- Public TitleAre there indications for the effectiveness of Schema Therapy for patients suffering from borderline personality disorder and alcohol dependency?
- Scientific TitleSchema therapy for Borderline Personality Disorder with Alcohol Dependency: A Multiple Baseline Case Series Study.
- ACRONYM
- hypothesis-Patients suffering from borderline personality disorder and alcohol dependency benefit from schema therapy in terms of decrease of symptoms and increase of quality of life.
-Impulsivity of participants predicts negative treatment outcomes
- Healt Condition(s) or Problem(s) studiedSchema therapy, Borderline personality disorder , Alcohol dependence, Impulsivity
- Inclusion criteria1. Age 18-65 year;
2. Alcohol Dependence (AD) as primary DSM-IV substance abuse disorder
3. Primary DSM-IV diagnosis of Borderline Personality Disorder (BPD) (beside AD);
4. BPD severity above 20 on the BPDSI interview;
5. Willingness to participate in the study (informed consent procedure);
6. Motivation to persist in abstinence of substances
- Exclusion criteria1. Lifetime psychotic disorder (short stress-related episodes are allowed, as described in DSM-IV BPD criterion 9);
2. IQ < 80 (in case of suspicion of low IQ, to be assessed with full intelligence test);
3. Unable to read, speak, or write Dutch;
4. ADHD (when suspected on basis of self-report the KID-SCID is used to assess ADHD) (When appropriately treated and thus in remission, not excluded.);
5. Bipolar disorder (SCID-1);
6. Homelessness
7. Schizotypical or schizoid personality disorder
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- control[default]
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate31-dec-2017
- Target number of participants20
- InterventionsBetween 75 and 84 sessions of individual Schema Therapy. Each therapy comprises four fases: 1) Treatment-as-usual (minimum: 5 sessions, maximum: 14 sessions), 2) Schema Therapy case conceptualisation (10 sessions), 3) Schema Therapy experiential techniques (45 sessions), 4) behavioral change (15 sessions).
- Primary outcome-BPD-checklist
-Ethyl Glucuronide (EtG; metabolite of alcohol) in urine sample
- Secondary outcome1)Borderline Personality Disorder Severity Index (BPDSI-week version), VAS craving for alcohol
2) Stop Signal Test, Card Playing Task, Delay Discounting Task
3) WHOQoL, Happiness Rating
- Timepointsbaseline
before each therapy session (twice a week)
end of therapy
three months follow-up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Michiel Boog
- CONTACT for SCIENTIFIC QUERIES Michiel Boog
- Sponsor/Initiator Bouman Mental Health Care, Erasmus University Medical Centre, Department of Medicine, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Bouman Mental Health Care
- Publications
- Brief summaryThe co-occurrence of BPD and AD is common, yet there is a lack of evidence for effective treatment of this co-morbidity. The current study is a pilot investigation of the effectiveness of Schema Therapy for BPD an AD. This study is designed as a multiple baseline case series study, with participants randomly assigned to baselines varying in length, to control for time effects. Twenty patients recruited in a Dutch mental health care institution specialized in substance use disorders, will receive two sessions of individual Schema Therapy each week. The duration of the 20 therapies will vary between 75 and 84 sessions.
A follow-up assessment will be done at three months after completion of the therapy.
- Main changes (audit trail)
- RECORD17-jun-2015 - 27-jul-2015


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