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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Hallucinations, Auditory

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients, including in-patients, out-patients and day hospital patients, will be recruited from psychiatric units of multiple hospital sites.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Left-handedness
• Intellectual disability
• Organic psychosis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV)	An instrument developed to assess cognitive ability and the relationship between intellectual functioning and memory of adults. The WAIS-IV (HK) short form includes four subscales - arithmetic, visual puzzle, information, and coding.	Baseline
Handedness as measured by Edinburgh Handedness Inventory (EHI)	A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.	Baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Psychosis; Mood; Brain imaging; Auditory hallucinations; Experience sampling method
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Hallucinations; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: Mood&AVH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No