Virtual Cognitive Behavioural Therapy for Psychosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
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.
详细描述
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:
- Examine the efficacy of virtually delivered CBT for schizophrenia-spectrum disorders to reduce symptoms and improve community functioning.
- Examine the feasibility and acceptability of virtually-delivered CBT for individuals with schizophrenia-spectrum disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be informed after their first assessment whether they were randomized to CBTp or TAU. Those in TAU are offered CBTp at the end of the study period. Assessors remain blind throughout the study and therefore do not partake in the treatment intervention. Due to the nature of the study, the treatment providers cannot be blinded as those they treat have clearly been randomized to the CBTp condition. The investigator is not blind to any of the randomization outcomes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: 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.
次要结局
- Personal and Social Performance Scale (PSP)(Change from Baseline to Follow-up (6 months post treatment))
- The Psychotic Symptom Rating Scales (PSYRATS)(Change from Baseline to Follow-up (6 months post treatment))
- Beliefs About Paranoia Scale (BAPS)(Change from Baseline to Follow-up (6 months post treatment))
- Brief Core Schema Scale (BCSS)(Change from Baseline to Follow-up (6 months post treatment))
- Dysfunctional Attitude Scale (DAS)(Change from Baseline to Follow-up (6 months post treatment))
- Calgary Depression Scale for Schizophrenia (CDSS)(Change from Baseline to Follow-up (6 months post treatment))
- The Questionnaire About the Process of Recovery (QPR)(Change from Baseline to Follow-up (6 months post treatment))
- Beliefs About Voices Questionnaire (BAVQ)(Change from Baseline to Follow-up (6 months post treatment))
- Experiences Questionnaire (EQ)(Change from Baseline to Follow-up (6 months post treatment))
- Davos Assessment of Cognitive Biases Scale (DACOBS)(Change from Baseline to Follow-up (6 months post treatment))
- Psychological Distance Scaling Task (PDST)(Change from Baseline to Follow-up (6 months post treatment))
- Childhood Trauma Questionnaire (CTQ)(Change from Baseline to Follow-up (6 months post treatment))
- Working Alliance Inventory (WAI)(Change from Baseline to Follow-up (6 months post treatment))
研究者
Michael Best
Assistant Professor
University of Toronto