Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 4
- 主要终点
- Social Functioning Scale (SFS)
研究概览
简要总结
It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.
详细描述
Dominant treatment approaches for schizophrenia-spectrum disorders improve psychiatric symptoms but do little to improve community functioning, leading to persistent disability and substantial economic burden. The proposed trial aims to examine the efficacy of a multi-mechanism approach to combining CBT and CR with the goal of predicting treatment response to either monotherapy or combination therapy. To date, there have been no randomized controlled trials examining the combination of CBT and CR. Given the differential mechanisms of CBT and CR, the combined multi-mechanism approach is expected to more effectively improve functional recovery than either monotherapy. Additionally, it is currently unknown what factors predict response to CBT or CR, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy. The proposed trial will be one of the largest trials of psychosocial interventions for schizophrenia-spectrum disorders ever conducted and will simultaneously evaluate the combined intervention and moderators of differential treatment response. Narrower fields of inquiry examining mono-mechanism interventions have demonstrated little utility in improving functional recovery in schizophrenia, thus, the proposed approach represents a critical advancement by examining the utility of a multi-mechanism cognitive intervention and determining characteristics of those requiring this level of treatment.
The goals of the current study are three-fold:
- Examine the efficacy of combining CBT and CR on the primary outcome of community functioning, and secondary outcomes of quality of life, personal recovery, psychiatric symptoms, and neurocognition compared to either intervention alone.
- Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR.
- Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This will be a double-blind (participant, assessor) trial. Participants will be informed that they will receive one individual session and one group session of treatment per week but will not be told which group they are assigned to. Participants will be instructed not to talk about their therapy to the assessor but if the assessor becomes aware of group allocation, then a new assessor will be assigned for all follow-up assessments. Due to the nature of the interventions, it is not possible for therapists to be blind to treatment condition, however, therapist fidelity to each intervention will be monitored through ratings on established fidelity measures. To protect against contamination separate therapists will deliver the active and control therapies.
The Principal Investigator also remains blind to randomization, as the trial manager is the only one who has access to this.
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
- •Aged 18-65 years
- •Diagnosed with schizophrenia-spectrum disorders
- •Can read, write, and speak English
排除标准
- •Primary substance use disorder
- •Neurodevelopmental disability or neurocognitive disorder
- •Neurostimulation in the past 30 days
- •CBT or CR in the past 6 months
结局指标
主要结局
Social Functioning Scale (SFS)
时间窗: Change between baseline assessment and 18-month assessment
The Social Functioning Scale (SFS) is an interview-based measure assessing basic social adjustment skills. It can be administered to both the participant and informants. Seven aspects are evaluated: (1) social engagement/withdrawal (with raw scores ranging from 0-15); (2) interpersonal behavior (with raw scores ranging from 0-9); (3) pro-social activities (with scores ranging from 0-66); (4) recreation (with scores ranging from 0-45); (5) independence-competence (with scores ranging from 0-39); (6) independence-performance (scores ranging from 0-39); and (7) employment/occupation (with scores ranging from 0-10). The lowest total score would be a 0 while the highest would be a 223. Higher scores are indicative of better social functioning.
次要结局
- Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)(Change between baseline assessment and 18 month assessment)
- World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)(Change between baseline assessment and 18-month assessment)
- Questionnaire About the Process of Recovery (QPR)(Change between baseline assessment and 18-month assessment)
- Positive and Negative Syndrome Scale (PANSS)(Change between baseline assessment and 18-month assessment)
- Psychotic Symptom Rating Scale (PSYRATS)(Change between baseline assessment and 18-month assessment)
- Neurocognitive Assessment(Change between baseline assessment and 18-month assessment)
- Beliefs About Paranoia Scale (BAPS)(Change between baseline assessment and 18-month assessment)
- Interpretations of Voices Inventory (IVI)(Change between baseline assessment and 18-month assessment)
- Brief Core Schema Scale (BCSS)(Change between baseline assessment and 18-month assessment)
- Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)(Change between baseline assessment and 18-month assessment)
- Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)(Change between baseline assessment and 18-month assessment)
- Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)(Change between baseline assessment and 18-month assessment)
- Questionnaire About the Process of Recovery (QPR)(Change between baseline assessment and 18-month assessment)
- Positive and Negative Syndrome Scale (PANSS)(Change between baseline assessment and 18-month assessment)
- Neurocognitive Assessment(Change between baseline assessment and 18-month assessment)
- World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)(Change between baseline assessment and 18-month assessment)
- Interpretations of Voices Inventory (IVI)(Change between baseline assessment and 18-month assessment)
- Brief Core Schema Scale (BCSS)(Change between baseline assessment and 18-month assessment)
- Psychotic Symptom Rating Scale (PSYRATS)(Change between baseline assessment and 18-month assessment)
- Beliefs About Paranoia Scale (BAPS)(Change between baseline assessment and 18-month assessment)
- Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)(Change between baseline assessment and 18-month assessment)
- Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)(Change between baseline assessment and 18-month assessment)
- Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)(Change between baseline assessment and 18 month assessment)
- Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)(Change between baseline assessment and 18-month assessment)
研究者
Michael Best
Assistant Professor, Principal Investigator
University of Toronto