Little research is being done on the effects of psychological treatment in patients with a bipolar disorder (BD) and comorbide borderline personality disorder (BPD) features. There are no recommendations included in the guideline for BD (Nolen et al…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The first primary outcome will be the symptomatic course of BD: occurrence,
frequency, severity, and duration of manic and depressive symptoms. The second
primary outcome will be the course, severity and burden of borderline
personality features.
Secondary outcome
Secondary study parameter are: quality of life, mental healthcare consumption,
and general psychopathological symptoms not related to bipolar disorder or
borderline personality features.
Background summary
The prevalence of personality disorders (PD) in patients with a bipolar
disorder (BD) is estimated at between 30% and 40%. This concerns personality
disorders from cluster B and C, particularly the borderline personality
disorder (BPD). The presence of personality disorder features negatively
impacts the course of bipolar disorder. Patients with BD and a comorbid
diagnosis of PD are more likely to be hospitalized, require more time to
achieve symptom stabilization, have more chronic impairments in occupational
and social functioning, are less compliant to medication, have greater levels
of suicidality and utilize more psychiatric services than patients with BD
alone (Bieling et al., 2007).
It is to be expected that specific interventions aimed at disfunctional
personality features will have a positive impact on the course of bipolar
disorder. The current study is specifically aimed at features of borderline
(instable) personality disorder, which in part overlap with the symptoms of
bipolar disorder.
Study objective
Little research is being done on the effects of psychological treatment in
patients with a bipolar disorder (BD) and comorbide borderline personality
disorder (BPD) features. There are no recommendations included in the guideline
for BD (Nolen et al., 2008). It is of great importance to test an integrated
treatment in terms of improving mood stabilization, quality of life and reduced
health consumptions.
The objective of the current study is to test the efficacy of STEPPS (Dutch:
VERS) specifically aimed at features of borderline personality disorder, as an
adjunctive intervention to treatment as usual (TAU). This may lead to an
integrated intervention for this patient population to improve the course of
bipolar disorder and quality of life, and to reduce the costs of treatment on a
longer term.
Study design
To screen for the presence of borderline personality disorder (BPD) features in
patients with a bipolair disorder (BD), patients will be ask to complete the
questionnaire PDQ-4+. Respondents that have a positive score with regard to the
presence of BPD will be invited for a diagnostic interview (SCID-II). This
interview will start with the part concerning BPD and will be completed if
patients score poitively on a minimum set of BPD-features. The diagnosis of
bipolar disorder (BD) will be verified with modules A, C and D of the MINI-plus
structured interview. BD patients with a comorbid BPD or a or a particular
constellation of borderline personality features (see study population) who do
not meet the exclusion criterion will be asked to participate the treatment
trial. All respondents will be assigned to the experimental condition. The
experimental condition includes "treatment as usual" (TAU) supplemented by
training emotion regulation (STEPPS/VERS).
Intervention
STEPPS/VERS training was developed to improve emotional regulation in patients
with borderline personality disorder. The group training (8-10 participants)
consists 20 weekly meetings of approximately 2,5 hours. The training consists
of four modules: psycho-education, emotion regulation skills, behaviour skills
and planning how to deal with emotions. Family members are involved in the
training to form a support group.
Study burden and risks
.STEPPS/VERS training has been applicated routinely in clinical practice for
patients with personality disorder. There are no unexpected risks, and
participants may benifit directly from the intervention. The extra burden of
all participants is undergoing a structured diagnostic interview and filling
out rating scales and questionnaires on a regular basis. Both may be
time-consuming and confronting.
A.J. Ernststraat 1187
Amsterdam 1081 HL
NL
A.J. Ernststraat 1187
Amsterdam 1081 HL
NL
Listed location countries
Age
Inclusion criteria
• age 18 - 65
• diagnosis of Bipolar Disorder-I, Bipolar Disorder-II, or Bipolar Disorder-NOS
• comorbid Borderline Personality Disorder or Borderline Personality Features (at least 3 of 9 DSM-IV-TR criteria, including at least impulsivity and anger bursts)
Exclusion criteria
• hospitalization for suicide risk
• current severe depressive episode (IDS-SR > 38)
• current severe manic episode (YMRS > 20)
• currently having a separate specialized treatment for substance abuse
• unable to understand Dutch language
• patients having received STEPPS/VERS in the past 2 years
• patients who participate external in a STEPPS/VERS training during inclusion
• patients currently receive a psychotherapy
• patients without informed consent
• unable to comply STEPPS protocol
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 | NL40029.029.12 |