EEG Outcomes From Cognitive Behavioural Therapy for Psychosis

NCT05703698 | Completed

• 1 other identifier: 38831
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Schizophrenia and Related Disorders

Keywords

Psychosis; Electroencephalogram; CBTp; CBT

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS is a 30-item semi-structured interview assessing positive, negative symptoms and general psychopathology. Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, 7 = extreme). The lowest score would be a 30 and the highest score would be 210. A higher score would indicate increased symptomology.

  Change from Baseline to Follow-up (6 months post treatment)

Secondary Outcomes (13)

• Personal and Social Performance Scale (PSP)

  Change from Baseline to Follow-up (6 months post treatment)

• The Psychotic Symptom Rating Scales (PSYRATS)

  Change from Baseline to Follow-up (6 months post treatment)

• Calgary Depression Scale for Schizophrenia (CDSS)

  Change from Baseline to Follow-up (6 months post treatment)

• The Questionnaire About the Process of Recovery (QPR)

  Change from Baseline to Follow-up (6 months post treatment)

• Beliefs About Paranoia Scale (BAPS)

  Change from Baseline to Follow-up (6 months post treatment)

Study Arms (1)

Cognitive Behavioural Therapy for psychosis

EXPERIMENTAL

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

Interventions

Cognitive Behavioural Therapy for Psychosis BEHAVIORAL

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.

Also known as: CBT, CBTp

Cognitive Behavioural Therapy for psychosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Toronto: lead
• Ontario Shores Centre for Mental Health Sciences: collaborator

Study Sites (1)

University of Toronto Scarborough

Scarborough Village, Ontario, M1C 1A4, Canada

Location

Related Publications (15)

• 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.

  PMID: 23172003 BACKGROUND

• 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.

  PMID: 19900962 BACKGROUND

• 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.

  PMID: 24731619 BACKGROUND

• 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.

  PMID: 24508320 BACKGROUND

• 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.

  PMID: 21969420 BACKGROUND

• 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.

  PMID: 29605187 BACKGROUND

• 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.

  PMID: 25449716 BACKGROUND

• 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.

  PMID: 16513862 BACKGROUND

• 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.

  PMID: 3616518 BACKGROUND

• 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.

  PMID: 18172019 BACKGROUND

• 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.

  PMID: 30929502 BACKGROUND

• 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.

  PMID: 25956629 BACKGROUND

• 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.

  PMID: 21044093 BACKGROUND

• 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.

  PMID: 15458988 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael W Best, Ph.D.

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Formulation-based CBTp will be delivered with a maximum of 30 sessions over 6 months based on an established manual.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: July 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)