|- candidate number||15514|
|- NTR Number||NTR4200|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-okt-2013|
|- Secondary IDs||METc2012/341 NL45716.042.13|
|- Public Title||Validation of a self-report questionnaire to assess (severity and characteristics of) auditory hallucinations|
|- Scientific Title||Validation of the self-report version of the Auditory Vocal Hallucination Rating Scale interview, the AVHRS-Q|
|- hypothesis||There is no hypothesis. We are comparing the AVHRS-I (interview) with the AVHRS-Q (self-report questionnaire).|
|- Healt Condition(s) or Problem(s) studied||Auditory-verbal hallucinations, Validation, Self test|
|- Inclusion criteria||- written informed consent;|
- auditory hallucinations in the past month;
- a good command of the Dutch language;
- an IQ >= 80.
|- Exclusion criteria||- no written informed consent;|
- no command of the Dutch language;
- IQ < 80;
- disorganization symptoms.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2013|
|- planned closingdate||1-nov-2014|
|- Target number of participants||32|
|- Interventions||During one single visit, patients will complete the self-report questionnaire AVHRS-Q and will be interviewed about their auditory hallucinations with the AVHRS-I. Alternately, either the AVHRS-Q or the AVHRS-I is administered first.|
|- Primary outcome||The correlation of the corresponding items and of the total score of the AVHRS-Q and the AVHRS-I.|
|- Secondary outcome||No secondary outcome measures.|
|- Timepoints||One assessment.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A.A. Bartels-Velthuis|
|- CONTACT for SCIENTIFIC QUERIES|| A.A. Bartels-Velthuis|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Rob Giel Research centre |
|- Brief summary||Rationale: Interviewing patients about their hallucinations is important, both for therapy and for research. The interview with the Auditory Vocal Hallucination Rating Scale (AVHRS-I) has been validated. However, a self-report version will be cost-effective by driving back staff costs.|
Objective: Aim of the study is to establish the validity of the self-report version of the AVHRS-I (interview), the AVHRS-Q.
Study design: Patients with auditory hallucinations are requested to participate in the study. After being fully informed about the purpose, a consent form is signed. During one visit, patients will complete the self-report questionnaire AVHRS-Q and will be interviewed about their auditory hallucinations with the AVHRS-I. Alternately, patients will first complete the AVHRS-Q or will first be interviewed.
Study population: Patients of the voices outpatient department and of the psychosis department of the University Center for Psychiatry at the University Medical Center Groningen.
Main study parameters/endpoints: The degree in which the scores on AVHRS-Q correspond to those on AVHRS-I.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Previous research with the AVHRS-I showed that patients are mostly very delighted to be questioned thoroughly about their voices. A pilot study showed that completion of the AVHRS-Q takes about 7 minutes.
|- Main changes (audit trail)|
|- RECORD||7-okt-2013 - 2-dec-2013|