EPIC: EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

Sponsor

University of Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05703698

Collaborator

Ontario Shores Centre for Mental Health Sciences (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Schizophrenia and Related Disorders	Behavioral: Cognitive Behavioural Therapy for Psychosis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Formulation-based CBTp will be delivered with a maximum of 20 sessions over 6 months based on an established manual.Formulation-based CBTp will be delivered with a maximum of 20 sessions over 6 months based on an established manual.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS) Total Score [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.

Secondary Outcome Measures

Personal and Social Performance Scale (PSP) [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.
The Psychotic Symptom Rating Scales (PSYRATS) [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.
Calgary Depression Scale for Schizophrenia (CDSS) [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.
The Questionnaire About the Process of Recovery (QPR) [Change from Baseline to Follow-up (6 months post treatment)]
The QPR is a self-report measure of recovery for people with psychosis.
Beliefs About Paranoia Scale (BAPS) [Change from Baseline to Follow-up (6 months post treatment)]
The BAPS assesses metacognitive beliefs about paranoia.
Beliefs About Voices Questionnaire (BAVQ) [Change from Baseline to Follow-up (6 months post treatment)]
BAVQ assesses metacognitive beliefs about voices.
Experiences Questionnaire (EQ) [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.
Brief Core Schema Scale (BCSS) [Change from Baseline to Follow-up (6 months post treatment)]
he BCSS assesses core beliefs that individuals hold about themselves and others.
Dysfunctional Attitude Scale (DAS) [Change from Baseline to Follow-up (6 months post treatment)]
DAS assesses dysfunctional beliefs.
Davos Assessment of Cognitive Biases Scale (DACOBS) [Change from Baseline to Follow-up (6 months post treatment)]
DACOBS assesses cognitive processing biases associated with psychosis.
Childhood Trauma Questionnaire (CTQ) [Change from Baseline to Follow-up (6 months post treatment)]
The CTQ assesses experiences of trauma during childhood.
Working Alliance Inventory (WAI) [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.
Psychological Distance Scaling Task (PDST) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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