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Psychotic DisordersNCT04752449

Virtual Cognitive Behavioural Therapy for Psychosis

A study testing Virtual Cognitive Behavioural Therapy for Psychosis in people with Psychotic Disorders and Schizophrenia, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psychotic Disorders, Schizophrenia
What is being tested?
Virtual Cognitive Behavioural Therapy for Psychosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
1 Feb 2021to 10 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Toronto Scarborough

    Scarborough Village, Ontario, M1C 1A4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Cognitive Behavioural Therapy for Psychosis
Keywords
cbt, psychosis, schizophrenia, cbtp, cognitive behavioural therapy, psychotherapy, virtual
Medical subject headings
Psychotic Disorders, Schizophrenia, Color Vision Defects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Cognitive Behavioural Therapy for PsychosisBehavioural

    Also called CBT, CBTp

    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.

Study groups in NCT04752449
Study groupRoleWhat they receive
Virtual Cognitive Behavioural Therapy for PsychosisExperimentalCBT 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.
Receives: Behavioral: Virtual Cognitive Behavioural Therapy for Psychosis
Treatment as UsualNo interventionParticipants continue with their regular standard of care without the addition of virtual Cognitive Behavioural Therapy for Psychosis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion26 Jan 2024
  4. Study completion10 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to receive either Virtual Cognitive Behavioural Therapy or to Treatment as Usual. All participants who receive Treatment as Usual will be offered CBT at the end of the study period.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752449
Sponsor's protocol ID
39916
Status last verified
Jul 2024
First submitted
8 Feb 2021
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16187769
  • 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.

    PubMed 15753237
  • 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.

    PubMed 17204532
  • 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.

    PubMed 17329467
  • 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.

    PubMed 24731619
  • 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.

    PubMed 24686725
  • 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.

    PubMed 24993642
  • 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/

    PubMed 32207892
  • 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.

    PubMed 28703017
  • 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.

    PubMed 21969420
  • 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.

    PubMed 29605187
  • Best MW, CIHR Knowledge Synthesis: Examining the Efficacy of Psychosocial Interventions for Schizophrenia-Spectrum disorders delivered through virtual care. 2020.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Cognitive Behavioural Therapy for Psychosis in people with Psychotic Disorders and Schizophrenia, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Change from Baseline to Follow-up (6 months post treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752449, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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Virtual Cognitive Behavioural Therapy for Psychosis | AzTrials