EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

Psychotic Disorders Clinical Trial

— EPIC  

Official title:

EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703698
• Other study ID #: 38831
• Status: Recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: University of Toronto
• Contact: Michael W Best, Ph.D.
• Phone: 6476896098
• Email: m.best[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Toronto Scarborough	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Ontario Shores Centre for Mental Health Sciences

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Alvarez-Jimenez M, Parker AG, Hetrick SE, McGorry PD, Gleeson JF. Preventing the second episode: a systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophr Bull. 2011 May;37(3):619-30. doi: 10.1093/schbul/sbp129. Epub 2009 Nov 9. — View Citation

Blackburn, I., James, I., Milne, D., Baker, C., Standart, S., Garland, A., & Reichelt, F. The revised cognitive therapy scale (CTS-R): Psychometric properties. Behavioural and Cognitive Psychotherapy. 2001; 29(4): 431-446.

Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD. Determinants of real-world functional performance in schizophrenia subjects: correlations with cognition, functional capacity, and symptoms. Am J Psychiatry. 2006 Mar;163(3):418-25. doi: 10.1176/appi.ajp.163.3.418. — View Citation

Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3. — View Citation

Jaaskelainen E, Juola P, Hirvonen N, McGrath JJ, Saha S, Isohanni M, Veijola J, Miettunen J. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull. 2013 Nov;39(6):1296-306. doi: 10.1093/schbul/sbs130. Epub 2012 Nov 20. — View Citation

Jackson F, Foti D, Kotov R, Perlman G, Mathalon DH, Proudfit GH. An incongruent reality: the N400 in relation to psychosis and recovery. Schizophr Res. 2014 Dec;160(1-3):208-15. doi: 10.1016/j.schres.2014.09.039. Epub 2014 Oct 22. — View Citation

Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261. — View Citation

Kim M, Lee TY, Lee S, Kim SN, Kwon JS. Auditory P300 as a predictor of short-term prognosis in subjects at clinical high risk for psychosis. Schizophr Res. 2015 Jul;165(2-3):138-44. doi: 10.1016/j.schres.2015.04.033. Epub 2015 May 5. — View Citation

Morrison AP, French P, Walford L, Lewis SW, Kilcommons A, Green J, Parker S, Bentall RP. Cognitive therapy for the prevention of psychosis in people at ultra-high risk: randomised controlled trial. Br J Psychiatry. 2004 Oct;185:291-7. doi: 10.1192/bjp.185.4.291. — View Citation

Morrison AP, Law H, Carter L, Sellers R, Emsley R, Pyle M, French P, Shiers D, Yung AR, Murphy EK, Holden N, Steele A, Bowe SE, Palmier-Claus J, Brooks V, Byrne R, Davies L, Haddad PM. Antipsychotic drugs versus cognitive behavioural therapy versus a combination of both in people with psychosis: a randomised controlled pilot and feasibility study. Lancet Psychiatry. 2018 May;5(5):411-423. doi: 10.1016/S2215-0366(18)30096-8. Epub 2018 Apr 5. Erratum In: Lancet Psychiatry. 2019 Jul;6(7):e16. — View Citation

Morrison AP, Turkington D, Pyle M, Spencer H, Brabban A, Dunn G, Christodoulides T, Dudley R, Chapman N, Callcott P, Grace T, Lumley V, Drage L, Tully S, Irving K, Cummings A, Byrne R, Davies LM, Hutton P. Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial. Lancet. 2014 Apr 19;383(9926):1395-403. doi: 10.1016/S0140-6736(13)62246-1. Epub 2014 Feb 6. — View Citation

Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2. — View Citation

Scherbaum S, Fischer R, Dshemuchadse M, Goschke T. The dynamics of cognitive control: evidence for within-trial conflict adaptation from frequency-tagged EEG. Psychophysiology. 2011 May;48(5):591-600. doi: 10.1111/j.1469-8986.2010.01137.x. Epub 2010 Nov 2. — View Citation

van der Gaag M, Valmaggia LR, Smit F. The effects of individually tailored formulation-based cognitive behavioural therapy in auditory hallucinations and delusions: a meta-analysis. Schizophr Res. 2014 Jun;156(1):30-7. doi: 10.1016/j.schres.2014.03.016. Epub 2014 Apr 14. — View Citation

Vinogradov S. Has the Time Come for Cognitive Remediation in Schizophrenia...Again? Am J Psychiatry. 2019 Apr 1;176(4):262-264. doi: 10.1176/appi.ajp.2019.19020160. No abstract available. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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