Virtual Cognitive Behavioural Therapy for Psychosis
- Conditions
- Psychotic DisordersSchizophrenia
- Interventions
- Behavioral: Virtual Cognitive Behavioural Therapy for Psychosis
- Registration Number
- NCT04752449
- Lead Sponsor
- University of Toronto
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
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 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Cognitive Behavioural Therapy for Psychosis 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.
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale (PANSS) Total Score Change from Baseline to Follow-up (6 months post treatment) 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.
- Secondary Outcome Measures
Name Time Method Personal and Social Performance Scale (PSP) Change from Baseline to Follow-up (6 months post treatment) 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.
The Psychotic Symptom Rating Scales (PSYRATS) Change from Baseline to Follow-up (6 months post treatment) 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.
Beliefs About Paranoia Scale (BAPS) Change from Baseline to Follow-up (6 months post treatment) 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.
Brief Core Schema Scale (BCSS) Change from Baseline to Follow-up (6 months post treatment) 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.
Dysfunctional Attitude Scale (DAS) Change from Baseline to Follow-up (6 months post treatment) 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.
Calgary Depression Scale for Schizophrenia (CDSS) Change from Baseline to Follow-up (6 months post treatment) 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.
The Questionnaire About the Process of Recovery (QPR) Change from Baseline to Follow-up (6 months post treatment) 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.
Beliefs About Voices Questionnaire (BAVQ) Change from Baseline to Follow-up (6 months post treatment) 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.
Experiences Questionnaire (EQ) Change from Baseline to Follow-up (6 months post treatment) 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.
Davos Assessment of Cognitive Biases Scale (DACOBS) Change from Baseline to Follow-up (6 months post treatment) 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.
Psychological Distance Scaling Task (PDST) Change from Baseline to Follow-up (6 months post treatment) 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.
Childhood Trauma Questionnaire (CTQ) Change from Baseline to Follow-up (6 months post treatment) 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.
Working Alliance Inventory (WAI) Change from Baseline to Follow-up (6 months post treatment) 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.
Trial Locations
- Locations (1)
University of Toronto Scarborough
🇨🇦Scarborough, Ontario, Canada