Virtual Cognitive Behavioural Therapy for Psychosis

Schizophrenia Clinical Trial

Official title:

Virtual Cognitive Behavioural Therapy for Psychosis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752449
• Other study ID #: 39916
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: October 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, 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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.

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 (28)

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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

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* Note: There are 28 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)	. The 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)