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

Completed

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

• Registration Number: NCT03449407
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

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Exclusion Criteria

• Left-handedness
• Intellectual disability
• Organic psychosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV)	Baseline	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.
Handedness as measured by Edinburgh Handedness Inventory (EHI)	Baseline	A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong