NCT03449407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

January 23, 2018

Last Update Submit

January 22, 2020

Conditions

Keywords

Auditory hallucinationsPsychosisMoodBrain imagingExperience sampling method

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Cognitive capacity as measured by the Wechsler Adult Intelligence Scale - IV (HK) short form (WAIS-IV)

    Baseline

  • Handedness as measured by Edinburgh Handedness Inventory (EHI)

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Left-handedness
  • Intellectual disability
  • Organic psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersHallucinationsPsychotic Disorders

Condition Hierarchy (Ancestors)

Mental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 28, 2018

Study Start

January 1, 2016

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations