EEG Outcomes From Cognitive Behavioural Therapy for Psychosis (EPIC)

January 19, 2023 updated by: Michael Best, University of Toronto
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Scarborough, Ontario, Canada, M1C 1A4
        • Recruiting
        • University of Toronto Scarborough
        • Contact:
        • Principal Investigator:
          • Michael W Best, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioural Therapy for psychosis
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.
Behavioral: Cognitive Behavioural Therapy for Psychosis
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.
Other Names:
  • CBT
  • CBTp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
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.
Change from Baseline to Follow-up (6 months post treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal and Social Performance Scale (PSP)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The PSP assesses community functioning through a brief interview with the participant about their daily activities.
Change from Baseline to Follow-up (6 months post treatment)
The Psychotic Symptom Rating Scales (PSYRATS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The PSYRATS assesses frequency and distress associated with the experiences of hallucinations and delusions based on the PANSS interview.
Change from Baseline to Follow-up (6 months post treatment)
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The CDSS is an interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia.
Change from Baseline to Follow-up (6 months post treatment)
The Questionnaire About the Process of Recovery (QPR)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The QPR is a self-report measure of recovery for people with psychosis.
Change from Baseline to Follow-up (6 months post treatment)
Beliefs About Paranoia Scale (BAPS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The BAPS assesses metacognitive beliefs about paranoia.
Change from Baseline to Follow-up (6 months post treatment)
Beliefs About Voices Questionnaire (BAVQ)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
BAVQ assesses metacognitive beliefs about voices.
Change from Baseline to Follow-up (6 months post treatment)
Experiences Questionnaire (EQ)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The EQ assesses decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness.
Change from Baseline to Follow-up (6 months post treatment)
Dysfunctional Attitude Scale (DAS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
DAS assesses dysfunctional beliefs.
Change from Baseline to Follow-up (6 months post treatment)
Davos Assessment of Cognitive Biases Scale (DACOBS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
DACOBS assesses cognitive processing biases associated with psychosis.
Change from Baseline to Follow-up (6 months post treatment)
Childhood Trauma Questionnaire (CTQ)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The CTQ assesses experiences of trauma during childhood.
Change from Baseline to Follow-up (6 months post treatment)
Working Alliance Inventory (WAI)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
The WAI is a measure completed by both the therapist and the client about the quality of the therapeutic relationship.
Change from Baseline to Follow-up (6 months post treatment)
Psychological Distance Scaling Task (PDST)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
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.
Change from Baseline to Follow-up (6 months post treatment)
Brief Core Schema Scale (BCSS)
Time Frame: Change from Baseline to Follow-up (6 months post treatment)
he BCSS assesses core beliefs that individuals hold about themselves and others.
Change from Baseline to Follow-up (6 months post treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Ontario Shores Centre for Mental Health Sciences

Investigators

  • Principal Investigator: Michael W Best, Ph.D., University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Estimate)

January 30, 2023

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38831 (Other Identifier: Organon)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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