The aim of the study is to observe the changes in severity of AVH symptoms during standard treatment of CBT or antipsychotics in patients with BPD.
ID
Source
Brief title
Condition
- Other condition
- Personality disorders and disturbances in behaviour
Synonym
Health condition
Auditieve verbale hallucinaties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: AVH-related items of the Psychotic Symptom Rating
Scales.
Secondary outcome
Secondary outcome measures: Voice Power Differential scale (VPDS), Visual
Analogue Scale (2 items severity
malevolence and omnipotence of the voices), Korte Klachten Lijst, Brief State
Paranoia checklist and the Sheehan
Disability Scale. These data will be collected once a week during the baseline,
intervention and follow-up period.
Furthermore for CBT, the Beliefs About Voices Questionnaire (BAVQ) and the
Social Comparison Rating Scale to voices
(SCRS) will be looked at.
In case of flupentixol treatment: Subjects Reaction to Antipsychotics will be
assessed three times.
Background summary
Auditory verbal hallucinations (AVH) are prevalent in patients with borderline
personality disorder (BPD) and are
associated with distress and severe consequences such as suicide attempts and
hospitalization.
Study objective
The aim of the study is to observe the changes in severity of AVH symptoms
during standard treatment of CBT or antipsychotics in patients with BPD.
Study design
Multiple Baseline case series design. Patients complete questionnaires weekly
before, during and (only in case of CBT) after treatment for hearing voices.
Treatment is either CBT for hearing voices or treatment with flupentixol.
Patients choose which treatment they get. The baseline period, i.e. the amount
of weeks patients will fill out questionnaires before the treatment is
determined by lottery.
Study burden and risks
No risks are expected due to the data collection. The observed treatments are
standard treatments, therefore risks are estimated as low. Flupentixol will be
prescribed according to the Parnassia Groep guidelines. Flupentixol
administration can be accompanied with side-effects such as weight gain, mood
symptoms, movement disorders and sleeping problems. CBT for voices will be
according to the protocols provided for this treatment
(www.gedachtenuitpluizen.nl)
Benefits of participation are possible relieve of symptoms, contribution to
knowledge about treatment and improving quality of treatments.
Lijnbaan 4
Den Haag 2512VA
NL
Lijnbaan 4
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older, BPD confirmed with the Structured Clinical Interview for
DSM-IV Axis II Personality Disorders (SCID II), AVH occurring at least daily,
and written informed consent for participation into this study from the
patient.
Exclusion criteria
Pregnancy and schizophrenia spectrum disorders, except for 1. Brief psychotic
disorder with hallucinations, and 2. Other specific or nonspecific
schizophrenia spectrum and other psychotic disorder in case of persistent
auditory hallucinations.
Design
Recruitment
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 | NL69811.058.19 |