The primary aim of the proposed study is to investigate whether adjunctive treatment of negative self-image with a specific intervention module (i.e. COMET) has added value in the treatment of patients with BPD compared with MBT without such a…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the frequency and severity of borderline
personality symptomatology as assessed with the Borderline Personality
Disorder Severity Index (BPDSI-IV), a semi-structured interview.
Secondary outcome
A secondary aim is to investigate whether this enhanced effectiveness is indeed
mediated by changes in self-esteem and/or changes in a bias for negative
emotional information.
Further it is tested whether a variation in the oxytocin receptor gene
moderates the outcomes.
Background summary
Borderline personality disorder (BPD) is a serious psychiatric situation with a
lifetime prevalence of about 3%.
This study focus on MBT as an evidence-based treatment for BPD and investigates
whether the effectiveness of this procedure can be enhanced.
Understanding the mechanisms through which MBT works is necessary to further
improve the treatment program.
In the search for alternative treatment components, in the present study a
specific intervention for low self-esteem is added to the MBT treatment.
Study objective
The primary aim of the proposed study is to investigate whether adjunctive
treatment of negative self-image with a specific intervention module (i.e.
COMET) has added value in the treatment of patients with BPD compared with MBT
without such a specific addition.
A secondary aim is to investigate whether this enhanced effectiveness is indeed
mediated by changes in self-esteem.
Study design
In this RCT, using music therapy as a credible placebo intervention, patients
are randomized into two conditions: MBT + music therapy or to MBT + COMET. Both
the music therapy and COMET are add-on modules, each with a duration of 8
weeks.
The first assessment is done at the onset of therapy (baseline); the second
measurement is assessed after the music and COMET therapy (about 5 months
post-baseline), the third measurement is done at the end of therapy (about 12
months post-baseline), and a final measurement is made at 24-months follow-up.
Intervention
Patients will receive either MBT + music therapy, or MBT + COMET.
Study burden and risks
All patients are treated with an evidence-based effective treatment (MBT),
which is the first choice of treatment at the psychiatric institute
Rivierduinen (location Duin en Bollenstreek) in the treatment of patients with
BPD. In addition, 50% of the included patients are treated with a specific
evidence-based treatment for low self-esteem (COMET) as an adjunct therapy.
COMET has proven to be effective and beneficial in patients with personality
disorders (Olij et al. 2006, Korrelboom et al. 2009; Korrelboom et al. 2011),
as well as in other clinical populations (Korrelboom et al., 2009; Korrelboom
et al., 2012). The remaining 50% of the patients are treated with music therapy
as an add-on module besides the normal MBT treatment. Music therapy is a method
often applied in clinical practice as a treatment for BPD (Christensen et al.
2007, Bollea and Guarino, 1991, Hannibal et al. 2012). However, there are no
studies indicating symptom relief in patients with BPD. In the present study
the main burden for the patient is the randomization, which implies that the
patients cannot choose the treatment they prefer. Moreover, at three time
points during treatment, and at follow-up, patients take part in assessment
sessions consisting of interviews, questionnaires and two experimental tasks.
However, the duration of these assessments does not exceed the duration of
normal psychological investigation which all patients in the ambulatory care
program *Personality Disorders* of Rivierduinen (location Duin en Bollenstreek)
must complete.
Participants do not receive any financial (or other) compensation for
participating in the study.
Grachtweg 36
Lisse 2161 HN
NL
Grachtweg 36
Lisse 2161 HN
NL
Listed location countries
Age
Inclusion criteria
Patients are registered with the Rivierduinen care program Personality Disorders
Aged between 18 and 65 years
Confirmation of the primary diagnosis of borderline personality disorder using the international personality disorder examination(IPDE) for DSM-IV
BPDSI-IV score bigger than 20
informed consent
Exclusion criteria
Insufficient command of the Dutch language
Severe comorbid psychopathology such as: psychotic disorders(except short, reactive psychotic episodes, that can be part of the clinical picture of BPD), bipolar disorder, dissociative identity disorder, antisocial personality disorder, attention deficit hyperactivity disorder, addiction of such severity that clinical detoxification is indicated (after which entering treatment is possible), psychiatric disorders secondary to medical conditions and mental retardation. Comorbid axis 1 and axis 2 disorders are allowed, as is medication use.
Simultaneous participation in another specific psychiatric treatment, except medication.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL42115.058.12 |