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EEG Outcomes From Cognitive Behavioural Therapy for Psychosis (EPIC)

Primary Purpose

Psychotic Disorders, Schizophrenia and Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy for Psychosis
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychosis, Electroencephalogram, CBTp, CBT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The inclusion criteria is anyone who meets the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder, are also 18-65 years of age, are not abusing drugs or alcohol and can read and speak English. Participants must be experiencing active symptoms of psychosis as indicated on the PANSS. Exclusion Criteria: Exclusion criteria include anyone with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, a medical history of head injury with loss of consciousness and those with physical handicaps that would prevent them from engaging in assessment procedures

Sites / Locations

  • University of Toronto ScarboroughRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioural Therapy for psychosis

Arm Description

CBTp will be delivered according to an established manual that the PI has previously used successfully for in-person treatment. Treatment will consist of individual sessions with a psychologist employed by the University of Toronto for 1-hour per week for 6-months, or by one of the listed clinical graduate students under his supervision. All treatment will be delivered in-person. This treatment will be delivered in addition to usual care and no changes to usual care will be required.

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS is a semi-structured interview that will be delivered through Zoom by one of the listed graduate students under the supervision of a registered clinical psychologist.

Secondary Outcome Measures

Personal and Social Performance Scale (PSP)
The PSP assesses community functioning through a brief interview with the participant about their daily activities.
The Psychotic Symptom Rating Scales (PSYRATS)
The PSYRATS assesses frequency and distress associated with the experiences of hallucinations and delusions based on the PANSS interview.
Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS is an interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia.
The Questionnaire About the Process of Recovery (QPR)
The QPR is a self-report measure of recovery for people with psychosis.
Beliefs About Paranoia Scale (BAPS)
The BAPS assesses metacognitive beliefs about paranoia.
Beliefs About Voices Questionnaire (BAVQ)
BAVQ assesses metacognitive beliefs about voices.
Experiences Questionnaire (EQ)
The EQ assesses decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness.
Brief Core Schema Scale (BCSS)
he BCSS assesses core beliefs that individuals hold about themselves and others.
Dysfunctional Attitude Scale (DAS)
DAS assesses dysfunctional beliefs.
Davos Assessment of Cognitive Biases Scale (DACOBS)
DACOBS assesses cognitive processing biases associated with psychosis.
Childhood Trauma Questionnaire (CTQ)
The CTQ assesses experiences of trauma during childhood.
Working Alliance Inventory (WAI)
The WAI is a measure completed by both the therapist and the client about the quality of the therapeutic relationship.
Psychological Distance Scaling Task (PDST)
A commonly used experimental task associated with cognitive processing biases in psychosis. The PDST gives measure of both how positive and negative a person views themselves, and how tightly held these beliefs are based on the clustering of the ratings.

Full Information

First Posted
January 19, 2023
Last Updated
January 19, 2023
Sponsor
University of Toronto
Collaborators
Ontario Shores Centre for Mental Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05703698
Brief Title
EEG Outcomes From Cognitive Behavioural Therapy for Psychosis
Acronym
EPIC
Official Title
EEG Outcomes From Cognitive Behavioural Therapy for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Ontario Shores Centre for Mental Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite overwhelming evidence for neurocognitive and neurophysiological factors involved in the etiology of psychosis, these factors have never been examined as mechanisms of improvement from CBTp. The first aim in the present study is to examine neurophysiological outcomes from CBTp using electroencephalography (EEG). The second aim is to examine neurocognitive outcomes from CBTp. This is an open-label pilot study. Twenty participants will receive CBTp and will be assessed at baseline and after 4 months.
Detailed Description
Despite decades of refining traditional treatments for schizophrenia-spectrum disorders, recovery rates remain unchanged at only 13.5%, and there is an urgent need for innovative new interventions. Cognitive behavioural therapy has more recently been applied to treating psychosis and initial evidence has suggested that cognitive behavioural therapy for psychosis (CBTp) is the most effective psychosocial intervention available for psychosis. However, the efficacy of CBTp has been limited to moderate effect sizes. Little is currently understood about the mechanisms of CBTp, and a greater understanding of mechanisms is necessary in order to improve treatment efficacy. Despite overwhelming evidence for neurocognitive and neurophysiological factors involved in the etiology of psychosis, these factors have never been examined as mechanisms of improvement from CBTp. Cognitive behavioural therapy for psychosis (CBTp) has demonstrated efficacy for reducing positive symptoms, negative symptoms, and improving community functioning6 for individuals diagnosed with psychotic disorders. Despite meta-analytic evidence for the efficacy of CBTp, little is known about the neurophysiological processes through which symptomatic and functional change occurs. Electroencephalography (EEG) provides temporally precise measurement of neurophysiological activity. Positive symptoms have been associated with reduced integration of discrepant information as indexed by the N400 event-related potential, reduced resting state power in the EEG alpha frequency band, and reduced cognitive control as indexed by EEG alpha and theta power during cognitive flanker tasks. Additionally, neurocognitive abilities such as attention, memory, and problem solving are the best predictors of community functioning among individuals diagnosed with psychotic disorders. Although CBTp improves community functioning,[6] neurophysiological and neurocognitive outcomes have never been examined as therapeutic mechanisms from CBTp, despite the fact that therapeutic processes would be expected to improve cognitive functions. Aim 1: Examine neurophysiological outcomes from CBTp using EEG. Aim 2: Examine neurocognitive outcomes from CBTp Hypothesis 1: After CBTp it is expected that participants will have a) increased N400 amplitude; b) increased resting state EEG alpha power; and c) reduced alpha and increased theta power during a flanker task Hypothesis 2: After CBTp participants will have increased global neurocognitive abilities as indexed by a neurocognitive composite score. Although CBTp has demonstrated efficacy to improve symptoms for individuals experiencing psychosis, little is known about the neurophysiological process through which this improvement occurs, and neither EEG nor neurocognitive outcomes from CBTp have ever been examined. The current results will provide preliminary evidence for neurophysiological mechanisms of change from CBTp that will increase understanding of the disorder and provide critical insights for refining psychotherapeutic interventions. Additionally, psychotherapy trials typically only examine psychological outcomes, however, if CBTp is effective it would be expected that this could be detected at both the neurophysiological level and neurocognitive level as well. My incorporation of multiple levels of assessment in clinical trials was recently praised as a goldstandard approach to trial methodology. This line of research is critical to improving the efficacy of CBTp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia and Related Disorders
Keywords
Psychosis, Electroencephalogram, CBTp, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Formulation-based CBTp will be delivered with a maximum of 20 sessions over 6 months based on an established manual.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioural Therapy for psychosis
Arm Type
Experimental
Arm Description
CBTp will be delivered according to an established manual that the PI has previously used successfully for in-person treatment. Treatment will consist of individual sessions with a psychologist employed by the University of Toronto for 1-hour per week for 6-months, or by one of the listed clinical graduate students under his supervision. All treatment will be delivered in-person. This treatment will be delivered in addition to usual care and no changes to usual care will be required.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy for Psychosis
Other Intervention Name(s)
CBT, CBTp
Intervention Description
CBT will be delivered according to an established manual that the PI has previously used successfully for in-person treatment. Treatment will consist of individual sessions with a psychologist employed by the University of Toronto for 1-hour per week for 6-months, or by one of the listed clinical graduate students under his supervision. All treatment will be delivered in-person. This treatment will be delivered in addition to usual care and no changes to usual care will be required.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The PANSS is a semi-structured interview that will be delivered through Zoom by one of the listed graduate students under the supervision of a registered clinical psychologist.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Secondary Outcome Measure Information:
Title
Personal and Social Performance Scale (PSP)
Description
The PSP assesses community functioning through a brief interview with the participant about their daily activities.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
The Psychotic Symptom Rating Scales (PSYRATS)
Description
The PSYRATS assesses frequency and distress associated with the experiences of hallucinations and delusions based on the PANSS interview.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Description
The CDSS is an interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
The Questionnaire About the Process of Recovery (QPR)
Description
The QPR is a self-report measure of recovery for people with psychosis.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Beliefs About Paranoia Scale (BAPS)
Description
The BAPS assesses metacognitive beliefs about paranoia.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Beliefs About Voices Questionnaire (BAVQ)
Description
BAVQ assesses metacognitive beliefs about voices.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Experiences Questionnaire (EQ)
Description
The EQ assesses decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Brief Core Schema Scale (BCSS)
Description
he BCSS assesses core beliefs that individuals hold about themselves and others.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Dysfunctional Attitude Scale (DAS)
Description
DAS assesses dysfunctional beliefs.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Davos Assessment of Cognitive Biases Scale (DACOBS)
Description
DACOBS assesses cognitive processing biases associated with psychosis.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Childhood Trauma Questionnaire (CTQ)
Description
The CTQ assesses experiences of trauma during childhood.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Working Alliance Inventory (WAI)
Description
The WAI is a measure completed by both the therapist and the client about the quality of the therapeutic relationship.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)
Title
Psychological Distance Scaling Task (PDST)
Description
A commonly used experimental task associated with cognitive processing biases in psychosis. The PDST gives measure of both how positive and negative a person views themselves, and how tightly held these beliefs are based on the clustering of the ratings.
Time Frame
Change from Baseline to Follow-up (6 months post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria is anyone who meets the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder, are also 18-65 years of age, are not abusing drugs or alcohol and can read and speak English. Participants must be experiencing active symptoms of psychosis as indicated on the PANSS. Exclusion Criteria: Exclusion criteria include anyone with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, a medical history of head injury with loss of consciousness and those with physical handicaps that would prevent them from engaging in assessment procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael W Best, Ph.D.
Phone
6476896098
Ext
1
Email
m.best@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Best, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto Scarborough
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1C 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael W Best, PhD
Phone
6476896098
Ext
1
Email
m.best@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Michael W Best, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

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