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

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ClinicalTrials.gov Identifier: NCT03449407
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Suzanne Ho-wai So, 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.

Condition or disease
Schizophrenia Spectrum and Other Psychotic Disorders Hallucinations, Auditory

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Multi-dimensional Investigations of Negative Emotions and Drug-resistant Auditory Verbal Hallucinations in Psychosis
Actual Study Start Date : January 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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) [ 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV) [ Time Frame: 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.

  2. Handedness as measured by Edinburgh Handedness Inventory (EHI) [ Time Frame: Baseline ]
    A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Left-handedness
  • Intellectual disability
  • Organic psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449407


Contacts
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Contact: Suzanne Ho-wai So (852)39436472 shwso@psy.cuhk.edu.hk

Locations
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Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Suzanne Ho-wai So    (852)39436472    shwso@psy.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Suzanne Ho-wai So, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03449407     History of Changes
Other Study ID Numbers: Mood&AVH
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suzanne Ho-wai So, Chinese University of Hong Kong:
Auditory hallucinations
Psychosis
Mood
Brain imaging
Experience sampling method

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms