A randomized multicentre trial is proposed. The aim of this study is to find answers to the following questions; 1) what is, compared to care as usual, the effect of MBT with respect to symptoms, level of functioning and well being, (mental) health…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome variable is the frequency and severity of manifestations of
Borderline Personality Disorder as measured with the Borderline Personality
Disorder Severity Index (BPDSI), a semi structured interview.
Secondary outcome
Suicide acts, self-mutilation: SSHI (Suïcide and Self-Harm Inventory),
Depression: Beck Depression Inventory (BDI)
Subjective experiences of symptoms: Symptom Checklist (SCL-90)
Social and interpersonal functioning: Inventory of Interpersonal Problems (IIP)
Personality functioning: Severity Indices of Personality Problems (SIPP)
Quality of life: EQ5D
Adherence to treatment: Realised Dose Instrument (RD).
Attachement style (HSL)
Consumption of (mental) health care: Tic-P
Work characteristics: Tic-P
Work characteristics: Tic-P
Additional costutility: QALY*s (Quality Adjusted Life Years
.
Background summary
Although there is a growing demand, evidence based treatments for patients with
severe personality disorders (mostly borderline personality disorders) are not
readily available. Recently, Mentalized Based Treatment (MBT) has been
developed for patients with borderline personality disorder. One randomized
controlled study demonstrated that a 5-day part-time MBT resulted in a clinical
improvement up to 5 years after treatment compared to care as usual for
patients with severe personality disorders (mostly borderline personality
disorders). MBT also proved to be cost efficient. Given the fact that evidence
for efficacy is based on only one RCT, it is essential new studies examine the
effects of MBT.
Study objective
A randomized multicentre trial is proposed. The aim of this study is to find
answers to the following questions; 1) what is, compared to care as usual, the
effect of MBT with respect to symptoms, level of functioning and well being,
(mental) health care consumption, and 2) what is the long term cost efficiency
of MBT. Based on the results we hope to be able to determine if further
implementation of intensive part time MBT can be recommended.
Study design
Patients with borderline personality disorder will be randomly assigned to one
of two trial arms. In the experimental condition patients receive MBT, in the
control condition patients receive care as usual. The intervention has a total
duration of 36 months and. A base line measurement will be performed at the
start of the intervention, and 6, 12, 18, 24, 30 and 36 months after. We expect
a gradual improvement on clinical outcome variables during the first 18 months
resulting in a 25% improvement at 18 months, compared with treatment as usual.
After this, we expect this clinical improvement to remain stable during the
next 18 months. At Arkin MBT can be offered to a total of 18 patients.
Patients will be analysed according to the intention to treat principle. Based
one experiences and literature (including the study by Bateman and Fonagy), the
proportion of patients who drop out within thefirst three month s of treatment
is approximately 20%. New patients will be recruited to fillup vacant MBT
places and followed up according to protocol. Therefore we expect to have a
total of 21patients in the analysis per condition in the Arkin sample. With a
sample of 21 patients per group, an effectsize of 0.9 on the BPDSI in an ANOVA
can be detected with a power of 81%.
With the participation of either Ingeest or DeViersprong we realize a
randomization of 36 patients to MBT(four groups on two locations), and 36
patients to the care as usual. With a sample of 36 patients pergroup,an effects
ize of 0.9 on the BPDSI in an ANOVA can be detected with a power of >90%.
Intervention
Following MBT theory, mentalizing is the ability to understand oneself and
others by inferring the mental states that lie behind overt behaviour. Failure
to retain mentalizing, particularly in the midst of emotional interactions, is
understood to be a core problem in (borderline) personality disorder, resulting
in severe emotional fluctuations, impulsivity, and vulnerability to
interpersonal and social interactions. The object of MBT is to increase
mentalization capacity which should improve affect regulation and interpersonal
relationships
Care as usual is provided by an outpatient team composed of psychiatrists,
psychologists and mental health nurses. The team is experienced in the
treatment of patients with personality disorders. Treatment is mainly ambulant.
Day-treatment or hospitalization is only offered when necessary. The team aims
at delivering optimal care by tailoring the intensity of the intervention and
catering from a variety of interventions such as family interventions, VERS or
Lineham training, social skills training, cognitive psychotherapy,
psychodynamic psychotherapy, farmacotherapy, addiction treatment, inpatient
treatment etcetera
Study burden and risks
Burden: 6 moments of measurement (interview and selfrating scales) in 36 months
Risks: non
Overschiestraat 65
1062 XD Amsterdam
NL
Overschiestraat 65
1062 XD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
A severe borderline personality disorder, based on standardized criteria for borderline personality disorder, assessed with the Dutch version of the Structured Clinical Interview for DSM-III-R (SCID-II) and the Borderline Personality Disorder Severity Index (BPDSI). Patients need to fullfill the criteria for borderline personality disorder as determined with the SCID-I, and need to have a total score on the BPDSI of > 25 indicating a severe borderline personality disorder.
Exclusion criteria
•Schizophrenia, as determined with the SCID-I,
•Bipolar disorder, as determined with the SCID-I,
•Substance dependency or misuse, as primary disorder as determined with the SCID-I
•Organic brain disorder,
•Mental impairment (IQ < 80)
•Inadequate mastery of the Dutch language
•Legal incapacity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL26308.097.09 |
OMON | NL-OMON23439 |