The Music Study in Refractory Psychosis

NCT ID: NCT02431949

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-05-31

Brief Summary

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The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results.

Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association.

The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.

Detailed Description

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1. BACKGROUND, PURPOSE AND JUSTIFICATION

The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results.

Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association.

The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.
2. RESEARCH OUTLINE This is a cross-sectional, observational study. Participating patients with refractory psychosis and healthy (age- and gender- matched) controls will undergo the Montreal Battery of Evaluation of Amusia assessment and assessments of cognition and symptoms.

The purpose of the study is to describe music perceptive ability in patients with refractory psychosis using the Montreal Battery of Evaluation of Amusia, a standardized and continuous measure of musical ability. The criterion for amusia is a score of 2 standard deviations below the mean of normal participants.

4\) OBJECTIVES

Primary:

The primary objective is to compare music perceptive ability in patients with clinically identified refractory psychosis with healthy subjects.

Secondary:

The secondary objectives are to compare the prevalence of amusia in a population of patients with refractory psychosis versus a population of healthy controls, and to compare psychiatric symptoms and cognition in patients with amusia versus patients without amusia. We will also determine if an association exists between music perceptive ability and:

* General and specific aspects of symptom severity, as assessed by standardized symptom rating scales and neurological status examination.
* General and specific aspects of cognition, as assessed by cognitive tests.
* Demographic variables such as sex, age, musical training and education. In addition, we will investigate potential pathways between symptomologies of psychosis, cognitive deficits and musical disability (if found) by using exploratory mediation analysis.

5\) RESEARCH METHOD We will recruit 100 participants, who will undergo the Montreal Battery of Evaluation of Amusia test and cognitive tests. Of these, 50 will be age- and gender- matched participants not diagnosed with a psychosis disorder who will serve as controls. The remaining 50 participants will be recruited from BCPP at UBC Hospital for in-patients diagnosed with refractory psychosis. For patients, participation will also involve assessments of their mental health (psychiatric symptoms).

6\) STATISTICAL ANALYSIS Inferential analyses will be used to assess differences in musical ability between patients and controls. It will also be used to evaluate differences in psychiatric symptoms and cognition between patients with amusia and those without amusia. Linear regression analyses will be done to relate psychiatric symptoms and cognition to musical ability. Mediation analyses will be performed to determine a causal model between symptoms, cognition and musical ability.

Conditions

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Schizophrenia Psychosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Controls

Participants without a psychosis disorder diagnosis.

No interventions assigned to this group

Patients

Participants with a psychosis disorder diagnosis- recruited from the BC Psychosis Program.

Admission to BCPP

Intervention Type OTHER

There is no intervention associated with this study.

Interventions

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Admission to BCPP

There is no intervention associated with this study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admission to BC Psychosis Program at UBC Hospital in Vancouver, B.C. with a diagnosis of a psychosis disorder (patients only)
* Fluency in English (patients and controls)
* Able to give consent

Exclusion Criteria

For controls and patients:

• Presence of hearing deficits

For controls only, history of:

* Diagnosis of psychosis disorder
* Antipsychotic medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alasdair Barr, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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BC psychosis ward at UBC Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sujin Im, BSc

Role: CONTACT

778-899-5969

Delrae Fawcett, MSc

Role: CONTACT

604-349-8982

Facility Contacts

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Delrae Fawcett

Role: primary

604-875-2000 x6115

Other Identifiers

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H14-02891

Identifier Type: -

Identifier Source: org_study_id

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