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CompletedNCT03449407Updated Jan 23, 2020

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

An observational study in Schizophrenia Spectrum and Other Psychotic Disorders and Hallucinations, Auditory, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Chinese University of Hong Kong · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
47
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Hallucinations, Auditory

Keywords

  • Auditory hallucinations
  • Psychosis
  • Mood
  • Brain imaging
  • Experience sampling method
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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Left-handedness
  • Intellectual disability
  • Organic psychosis
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
47 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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).

    Time frame: Baseline

  4. 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.

    Time frame: 1 week

  5. 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.

    Time frame: 1 week

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

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Study locations

1 site
  • Chinese University of Hong Kong
    Hong Kong, Hong Kong
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03449407
Lead sponsor
Chinese University of Hong Kong
Responsible party
Suzanne Ho-wai So (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Feb 28, 2018
Start date
Jan 2016
Primary completion
Jun 30, 2019
Completion
Dec 31, 2019
Last update
Jan 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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