Virtual Cognitive Behavioural Therapy for Psychosis

Virtual Cognitive Behavioural Therapy for Psychosis: A Randomized Controlled Trial

Participants with schizophrenia-spectrum disorders who are experiencing active symptoms of psychosis will randomized to either receive 6 months of individual cognitive behavioural therapy for psychosis or to receive treatment as usual. Participants will be assessed at baseline, 6 months, and 12 months.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Behavioral: Virtual Cognitive Behavioural Therapy for Psychosis

Detailed Description

Schizophrenia-spectrum disorders are the most persistent, debilitating, and economically burdensome mental illnesses worldwide, and are associated with the greatest per-patient expense of all mental health conditions. Schizophrenia is associated with a 15-20 year decrease in life expectancy, 5-fold increase in likelihood of death by suicide, and a significant decrease in quality of life. Antipsychotic medications are the first line treatment for individuals with schizophrenia spectrum disorders and are prescribed to nearly every service-user. However, in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial (one of the largest antipsychotic trials in 1493 individuals with schizophrenia), medication effects on psychosocial functioning were small (d = 0.25). Thus, the primary treatment available to all individuals with schizophrenia does little to improve community functioning. This may partially be a result of the limited efficacy of antipsychotic medication to improve neurocognitive abilities, widely recognized as a core feature of schizophrenia, and one recommendation stemming from the CATIE trial was that "more intensive psychosocial rehabilitative services, including cognitive rehabilitation, may be needed to affect more substantial gains in functioning."

Cognitive behavioural therapy (CBT) is a psychological intervention originally developed to treat depression, and subsequently adapted to treat schizophrenia spectrum disorders. CBT has demonstrated moderate treatment effects (d = 0.36 - 0.44) in multiple meta-analyses and is widely recommended for the treatment of schizophrenia in international guidelines. CBT involves clients learning to evaluate their cognitive content in order to develop more accurate representations of the world. CBT has proven effective for improving hallucinations, delusions, negative symptoms, and personal recovery.

Despite the established efficacy of CBT delivered through in-person methods, most clinics have discontinued in-person treatments as a result of the COVID-19 pandemic and have moved to virtual delivery methods. While it has been assumed that virtual delivery of CBT is equivalent to in-person delivery, our recent systematic review demonstrated that there has never been a trial examining the efficacy of virtually delivered CBT for psychosis. Characteristics of schizophrenia such as paranoia, and disorganization already present challenges to psychological treatment and it is possible that this challenge will be further exacerbated by treatment delivery through virtual methods. Additionally, it is unclear the extent to which individuals with schizophrenia-spectrum disorders will be interested in receiving virtual CBT and capable of using the technology that is required.

Thus the goals of the current study are two-fold:

1. Examine the efficacy of virtually delivered CBT for schizophrenia-spectrum disorders to reduce symptoms and improve community functioning.
2. Examine the feasibility and acceptability of virtually-delivered CBT for individuals with schizophrenia-spectrum disorders.

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 therapist for 1-hour per week for 6-months. Therapists will be either a registered clinical psychologist or a graduate student in clinical psychology under the supervision of a registered clinical psychologist. All treatment will be delivered virtually in the participant's home using the online platform Zoom which is PHIPA/PIPEDA compliant. If participants do not have the technology required for virtual sessions then a tablet will be loaned to them for the duration of treatment. This treatment will be delivered in addition to usual care and no changes to usual care will be required.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada, M1C 1A4
      • University of Toronto Scarborough

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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, know how to use a computer, 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 who has received CBT in the past 6 months, or anyone with a neurological disease or neurological damage that would make it difficult to participate in a talk therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual 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 virtually in the participant's home using the online platform Zoom which is PHIPA/PIPEDA compliant. If participants do not have the technology required for virtual sessions, then a tablet will be loaned to them for the duration of treatment. This treatment will be delivered in addition to usual care and no changes to usual care will be required.	Behavioral: Virtual 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 virtually in the participant's home using the online platform Zoom which is PHIPA/PIPEDA compliant. If participants do not have the technology required for virtual sessions, then a tablet will be loaned to them for the duration of treatment. This treatment will be delivered in addition to usual care and no changes to usual care will be required.; Other Names: CBT; CBTp
No Intervention: Treatment as Usual; Participants continue with their regular standard of care without the addition of virtual Cognitive Behavioural Therapy for Psychosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal and Social Performance Scale (PSP)	The PSP assesses community functioning through a brief interview with the participant about their daily activities. It contains 4 areas: (1) socially useful activities; including work and study; (2) personal and social relationships; (3) self-care; (4) disturbing and aggressive behaviors. The total score ranges from 1 to 100 and is interpreted on a 10-point intervals. Lower scores indicates more severe functional impairment while higher scores indicate better functioning.	Change from Baseline to Follow-up (6 months post treatment)
The Psychotic Symptom Rating Scales (PSYRATS)	The PSYRATS assesses frequency and distress associated with the experiences of auditory hallucinations and delusions based on the PANSS interview. Each of the 17 items is scored on a 5-point scale, where a score of 0 indicates no presence, and 4 indicates the highest severity. The lowest score would be a 0 and the highest score would be 68. A higher score would indicate increased symptomology.	Change from Baseline to Follow-up (6 months post treatment)
Calgary Depression Scale for Schizophrenia (CDSS)	The CDSS is a 9-item interview-based measure of depression symptoms specifically designed for use with people experiencing schizophrenia. Each item is scored on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 4 = severe). The lowest score would be a 0 and the highest score would be 36. A higher score would indicate increased severity of depressive symptoms.	Change from Baseline to Follow-up (6 months post treatment)
Beliefs About Paranoia Scale (BAPS)	The BAPS is a 31-item self-report measure assessing metacognitive beliefs about paranoia. The degree of agreement to each statement is scored on a 4-point scale (1 = not at all, 2 = somewhat, 3 = moderately so, 4 = very much). Scales include positive, negative and normalizing beliefs about paranoia, and paranoia as a survival strategy. The lowest score would be 31 and the highest score would be 124. Higher scores are indicative of more beliefs and are shown to be related to paranoid ideation.	Change from Baseline to Follow-up (6 months post treatment)
Brief Core Schema Scale (BCSS)	The BCSS is a 24-item self-report measure assessing positive and negative judgments individuals hold about themselves and others. Responses are first given dichotomously as "no" or "yes". "No" is scored as 0 and if the answers are "yes", the intensity of beliefs are then rated on a 4-point scale (1 = believe it slightly, 2 = believe it moderately, 3 = believe it very much, 4 = believe it totally). The lowest score would be a 0 and the highest score would be a 96. Higher scores in the positive-self subscale indicate more positive beliefs about selves, while higher scores in the negative-self subscale indicate more negative beliefs about selves. Higher scores in the positive-others subscale indicate more positive beliefs about others, while higher scores in the negative-others subscale indicate more negative beliefs about others.	Change from Baseline to Follow-up (6 months post treatment)
Childhood Trauma Questionnaire (CTQ)	The CTQ is a 28-item self-report measure assessing experiences of trauma during childhood. Frequency of experiences is reported on a 5-point scale, ranging from "never true" to "very often true". Reverse-coded items are included. The lowest score would be a 28 and the highest score would be a 140. Higher scores would indicate more trauma exposure.	Change from Baseline to Follow-up (6 months post treatment)
Working Alliance Inventory (WAI)	The WAI assesses the quality of the therapeutic relationship. 36 items are to be completed both by the therapist and the client. Frequency of experiences are rated on a 7-point Likert scale (1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always). Reverse-coded items are included. The lowest score would be a 36 and the highest score would be a 252. Highest scores would indicate more therapeutic alliance.	Change from Baseline to Follow-up (6 months post treatment)
Psychological Distance Scaling Task (PDST)	The PDST is an experimental task associated with cognitive processing biases in psychosis. It 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. Participants would place adjectives on the grid based on self-descriptiveness and valence, while responses ranging from "not at all like me" to "very much like me" and "very negative" to "very positive". Smaller interstimulus distances among negative self-relevant adjectives and greater interstimulus distances among positive self-relevant adjectives would indicate more negative biases about selves.	Change from Baseline to Follow-up (6 months post treatment)
The Questionnaire About the Process of Recovery (QPR)	The QPR is a self-report measure assessing recovery with people experiencing psychosis. This version contains 22 items while the response to each statement is scored on a 5-point Likert scale ranging from "0 = strongly disagree" to "4 = strongly agree". The lowest possible score is 0 and the highest score could be 88. Higher scores would indicate better recovery.	Change from Baseline to Follow-up (6 months post treatment)
Beliefs About Voices Questionnaire (BAVQ)	The BAVQ-R is a 35-item self-report measure assessing metacognitive perception, feelings about and reaction to auditory hallucinations. The degree of agreement to each statement is scored on a 4-point scale, ranging from disagree to strongly agree. Five subscales (malevolence, benevolence, omnipotence, resistance, engagement) are included. The lowest possible score is 0 and the highest score would be 105. Higher scores would indicate a tighter relationship with voices.	Change from Baseline to Follow-up (6 months post treatment)
Experiences Questionnaire (EQ)	The EQ is a 11-item self-report measure assessing decentering which is the process of distancing one's self from their thoughts and is associated with mindfulness. Frequency of experiences is scored on a 5-point scale, ranging from "1 = never" to "5 = all the time". The lowest possible score is 11 while the highest score would be 55. Higher scores would indicate increased levels of self-acceptance and mindfulness.	Change from Baseline to Follow-up (6 months post treatment)
Dysfunctional Attitude Scale (DAS)	The DAS is a 40-item self-report measure assessing dysfunctional beliefs. The degree of agreement to each statement is scored on a 7-point Likert scale (1 = agree totally, 2 = agree very much, 3 = agree slightly, 4 = neutral, 5 = disagree slightly, 6 = disagree very much, 7 = disagree totally). The lowest possible scale is 40 while the highest possible scale is 280. Higher scores would indicate more negative beliefs.	Change from Baseline to Follow-up (6 months post treatment)
Davos Assessment of Cognitive Biases Scale (DACOBS)	The DACOBS is a 42-item self-report inventory assessing cognitive processing biases associated with psychosis. The degree of agreement to each statement is scored on a 7-point Likert scale, ranging from "1 = strongly disagree" to "7 = strongly agree". The lowest score would be a 42 and the highest score would be a 294. Higher scores would indicate more cognitive biases.	Change from Baseline to Follow-up (6 months post treatment)

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Ontario Shores Centre for Mental Health Sciences
• Investigators: Principal Investigator: Michael W Best, PhD, University of Toronto

Publications and helpful links

General Publications

• 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.
• Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.
• Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. doi: 10.1001/archpsyc.62.3.247.
• Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
• Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005 Sep;66(9):1122-9. doi: 10.4088/jcp.v66n0906.
• Eack SM, Newhill CE. Psychiatric symptoms and quality of life in schizophrenia: a meta-analysis. Schizophr Bull. 2007 Sep;33(5):1225-37. doi: 10.1093/schbul/sbl071. Epub 2007 Jan 4.
• Swartz MS, Perkins DO, Stroup TS, Davis SM, Capuano G, Rosenheck RA, Reimherr F, McGee MF, Keefe RS, McEvoy JP, Hsiao JK, Lieberman JA; CATIE Investigators. Effects of antipsychotic medications on psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE study. Am J Psychiatry. 2007 Mar;164(3):428-36. doi: 10.1176/ajp.2007.164.3.428.
• Chadwick P. Person-based cognitive therapy for distressing psychosis. (Wiley & Sons Ltd., 2006).
• Kingdon DG, Turkington D. Cognitive Therapy of Schizophrenia. The Guilford Press, 2005.
• Morrison AP, Renton JC, Dunn H, Williams S, Bentall RP. Cognitive Therapy for Psychosis: A Formulation-Based Approach. Routledge, 2004
• 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.
• Burns AM, Erickson DH, Brenner CA. Cognitive-behavioral therapy for medication-resistant psychosis: a meta-analytic review. Psychiatr Serv. 2014 Jul;65(7):874-80. doi: 10.1176/appi.ps.201300213.
• Velthorst E, Koeter M, van der Gaag M, Nieman DH, Fett AK, Smit F, Staring AB, Meijer C, de Haan L. Adapted cognitive-behavioural therapy required for targeting negative symptoms in schizophrenia: meta-analysis and meta-regression. Psychol Med. 2015 Feb;45(3):453-65. doi: 10.1017/S0033291714001147. Epub 2014 May 22.
• Psychosis and schizophrenia in adults: prevention and management. London: National Institute for Health and Care Excellence (NICE); 2014 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK555203/
• Norman R, Lecomte T, Addington D, Anderson E. Canadian Treatment Guidelines on Psychosocial Treatment of Schizophrenia in Adults. Can J Psychiatry. 2017 Sep;62(9):617-623. doi: 10.1177/0706743717719894. Epub 2017 Jul 13.
• 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.
• Best MW, CIHR Knowledge Synthesis: Examining the Efficacy of Psychosocial Interventions for Schizophrenia-Spectrum disorders delivered through virtual care. 2020.
• Morrison AP, Renton JC, Dunn H, Williams S, Bentall RP. Cognitive therapy for psychosis: A formulation-based approach. Routledge, 2004.
• Nasrallah H, Morosini P, Gagnon DD. Reliability, validity and ability to detect change of the Personal and Social Performance scale in patients with stable schizophrenia. Psychiatry Res. 2008 Nov 30;161(2):213-24. doi: 10.1016/j.psychres.2007.11.012. Epub 2008 Oct 11.
• Beck AT, Weissman F. Dysfunctional Attitudes Scale (DAS). 1987.
• van der Gaag M, Schutz C, Ten Napel A, Landa Y, Delespaul P, Bak M, Tschacher W, de Hert M. Development of the Davos assessment of cognitive biases scale (DACOBS). Schizophr Res. 2013 Mar;144(1-3):63-71. doi: 10.1016/j.schres.2012.12.010. Epub 2013 Jan 15.
• Bernstein DP, Fink L, Handelsman L, Foote J. Childhood trauma questionnaire. Assessment of family violence: A handbook for researchers and practitioners. 1998.
• Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. Journal of Counselling Psychology. 1989; 36(2): 223.
• Ross RM, McKay R, Coltheart M, Langdon R. Jumping to Conclusions About the Beads Task? A Meta-analysis of Delusional Ideation and Data-Gathering. Schizophr Bull. 2015 Sep;41(5):1183-91. doi: 10.1093/schbul/sbu187. Epub 2015 Jan 22.
• Diehl C, Yin S, Markell H, Gallop R, Gibbons MBC, Crits-Christoph P. The Measurement of Cognitive Schemas: Validation of the Psychological Distance Scaling Task in a Community Mental Health Sample. Int J Cogn Ther. 2017;10(1):17-33. doi: 10.1521/ijct_2016_09_18.
• Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.
• Best MW, Gale D, Tran T, Haque MK, Bowie CR. Brief executive function training for individuals with severe mental illness: Effects on EEG synchronization and executive functioning. Schizophr Res. 2019 Jan;203:32-40. doi: 10.1016/j.schres.2017.08.052. Epub 2017 Sep 19.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia; psychosis; psychotherapy; virtual; cognitive behavioural therapy; cbt; cbtp
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 39916

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
• product manufactured in and exported from the U.S.: No