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Clinical Trials/NCT03449407
NCT03449407
Completed
Not Applicable

Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis

Chinese University of Hong Kong1 site in 1 country47 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia Spectrum and Other Psychotic Disorders
Sponsor
Chinese University of Hong Kong
Enrollment
47
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suzanne Ho-wai So

Assistant Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 65 years
  • Clinical diagnosis of schizophrenia spectrum disorder
  • Present hallucinations

Exclusion Criteria

  • Left-handedness
  • Intellectual disability
  • Organic psychosis

Outcomes

Primary Outcomes

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)

Time Frame: Baseline

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.

Mood states as measured by Visual analogue scale (VAS)

Time Frame: 1 week

A simple visual analogue scale assessing state depression, state anxiety and state happiness will be conducted.

Depressive symptomatology as measured by Calgary Depression Scale (CDS)

Time Frame: Baseline

Calgary Depression Scale (CDS) is a nine-item structured interview scale that assesses depressive symptoms in patients with schizophrenia.

Beliefs about voices as measured by Beliefs about Voices Questionnaire - Revised (BAVQ-R)

Time Frame: Baseline

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).

Anxiety severity as measured by Beck anxiety inventory (BAI)

Time Frame: 1 week

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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