Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis
1 other identifier
observational
47
1 country
1
Brief Summary
Auditory verbal hallucinations (AVH) are commonly reported as source of distress, disability and mortality in schizophrenia. Despite proven efficacy of antipsychotics, many patients still experience drug-refractory AVH. It has been postulated that AVH is maintained by negative emotions. Yet, little is known about the temporal relationship and underlying mechanisms between negative affect and AVH. Utilizing both an ecologically-validated method and brain imaging technique, this study aims to uncover the role of emotions in the maintenance of psychotic symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 23, 2020
January 1, 2020
3.5 years
January 23, 2018
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS), Scale of Assessment for Positive Symptoms (SAPS), and the Psychotic Symptom Rating Scales (PSYRATS)
Positive and Negative Syndrome Scale (PANSS) is an interview-based assessment of the severity of symptoms associated with schizophrenia, including positive, negative, and general psychopathology. Scale of Assessment for Positive Symptoms (SAPS) is an interview-based scale of positive symptoms of schizophrenia. SAPS consists of four areas: hallucinations, delusions, bizarre behaviour and positive formal thought disorder. Each area includes ratings of specific symptoms and a global rating. The Psychotic Symptom Rating Scale (PSYRATS) is a 17-item semi-structured interview measuring the severity of multiple dimensions of auditory hallucinations and delusions, including conviction and duration.
Baseline
Depressive symptomatology as measured by Calgary Depression Scale (CDS)
Calgary Depression Scale (CDS) is a nine-item structured interview scale that assesses depressive symptoms in patients with schizophrenia.
Baseline
Beliefs about voices as measured by Beliefs about Voices Questionnaire - Revised (BAVQ-R)
BAVQ-R is a self-report questionnaire that consists of three subscales pertaining to beliefs about voices: malevolence (i.e. voices as evil and persecutory), benevolence (i.e. voices as helpful), and omnipotence (i.e. voices as controlling and powerful).
Baseline
Anxiety severity as measured by Beck anxiety inventory (BAI)
BAI is a self-report questionnaire that measures anxiety severity and unique symptom features that are independent of that in depression, including somatic symptoms and subjective experience of panic and anxiety.
1 week
Mood states as measured by Visual analogue scale (VAS)
A simple visual analogue scale assessing state depression, state anxiety and state happiness will be conducted.
1 week
Secondary Outcomes (2)
Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV)
Baseline
Handedness as measured by Edinburgh Handedness Inventory (EHI)
Baseline
Eligibility Criteria
Patients, including in-patients, out-patients and day hospital patients, will be recruited from psychiatric units of multiple hospital sites.
You may qualify if:
- Aged 18 to 65 years
- Clinical diagnosis of schizophrenia spectrum disorder
- Present hallucinations
You may not qualify if:
- Left-handedness
- Intellectual disability
- Organic psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 23, 2018
First Posted
February 28, 2018
Study Start
January 1, 2016
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
January 23, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share