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

Schizophrenia Spectrum and Other Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449407
• Other study ID #: Mood&AVH
• Status: Completed
• Start date: January 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 65 years

• Clinical diagnosis of schizophrenia spectrum disorder

• Present hallucinations

Exclusion Criteria:

• Left-handedness

• Intellectual disability

• Organic psychosis

Related Conditions & MeSH terms

• Hallucinations
• Hallucinations, Auditory
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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