Main objectives: to compare the effect of a short term intensive DBT treatment program (3 months) with the effect of outpatient DBT, (1) in terms of reduction of suicidal and/or self-destructive behaviour and (2) with regard to reduction of severity…
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the number of suicide attempts/self-destructive acts
(measured by the Life Time Parasuicide Count and The Borderline Personality
Severity Index). We expect that after 12 weeks 20% of the patients of the
intervention group still show suicidal and/or self-destructive behaviour
compared to 60% of the patients in the control condition, and that this
difference sustains at 24 weeks and will gradually be reduced between 24 and 52
weeks.
Secondary outcome
Second study parameter is the severity of borderline symptomatology (as
measured by the BPDSI), reduced BPDSI scores. The results on the SF-36 (Quality
of life), on the BSI (psychopathological symptoms) and on the IDS-SR
(depression), part of the Routine Outcome Monitoring of Rivierduinen, will be
taken into account also. We expect a stronger decline in LPC scores and in
BPDSI general symptomatology scores in the first 4 months, and that these
differences sustain at 24 weeks and will gradually be reduced between 24 and 52
weeks.
Background summary
The efficacy of Dialectical Behavior Therapy (DBT) in reducing suicidal and
self-destructive behaviour with chronically suicidal borderline patients,
within six to twelve months, has been firmly established in more than seven
RCT*s. The reduction of this life threatening behaviour (i.e. learn to regulate
emotions and control impulses), enhances the quality of life of the patients
and opens the opportunity to solve the problems that have resulted in the
problem behaviour in the first place. Therefore, the faster the reduction takes
place, the better. DBT is an outpatient program. It is hypothesized that
intensification of the program, by giving the patients partial inpatient
treatment for 4 months, will accelerate the reduction of the suicidal and
self-destructive behaviour.
Study objective
Main objectives: to compare the effect of a short term intensive DBT treatment
program (3 months) with the effect of outpatient DBT, (1) in terms of reduction
of suicidal and/or self-destructive behaviour and (2) with regard to reduction
of severity of general BPD symptomatology.
Study design
A randomized controlled trial with four measurement occasions; baseline (before
randomization), and 12, 24 and 52 weeks after the start of the treatment.
Study burden and risks
The program has been carried out since October 2009 as a pilot. Even though it
was expected that the burden associated with participation would be higher for
participants, mainly because they have to live together in a group, results
show that patient drop out equals the drop out found in standard DBT, nor has
there been any suicide. Therefore the burden or risk does not seem to be higher
than in standard DBT (or other evidence based programs for BPD like
Mentalisation Based Treatment).
Oegstgeest
2342 AN
NL
Oegstgeest
2342 AN
NL
Listed location countries
Age
Inclusion criteria
(young) adult borderline patients with severe suicidal and selfdestructive behavior with al least 6 out of 9 diagnostic criteria of the DSM-IV TR of the bordeline personality disorder, with a Borderline Personality Disorder Severity Index total score of at least 24.
Exclusion criteria
IQ < 80, a chronic psychotic condition, bipolar disorder, hard drug abuse and a forced treatment framework.
Design
Recruitment
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 | NL35714.058.11 |