Clinical trial NCT05703698: EEG Outcomes From Cognitive Behavioural Therapy for Psychosis
Official title: EEG Outcomes From Cognitive Behavioural Therapy for Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia and Related Disorders
Keywords: Psychosis
Electroencephalogram
CBTp
CBT
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Shores Centre for Mental Health Sciences
First posted: 2023-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Formulation-based CBTp will be delivered with a maximum of 30 sessions over 6 months based on an established manual.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
Secondary outcomes:
measure: Personal and Social Performance Scale (PSP)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: The Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: The Questionnaire About the Process of Recovery (QPR)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Beliefs About Paranoia Scale (BAPS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Beliefs About Voices Questionnaire (BAVQ)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Experiences Questionnaire (EQ)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Brief Core Schema Scale (BCSS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Dysfunctional Attitude Scale (DAS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Davos Assessment of Cognitive Biases Scale (DACOBS)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Working Alliance Inventory (WAI)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
measure: Psychological Distance Scaling Task (PDST)
timeFrame: Change from Baseline to Follow-up (6 months post treatment)
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: University of Toronto Scarborough
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael W Best, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.