Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 16
- 主要终点
- Change in Social and Occupational Functioning Scale Scores
研究概览
简要总结
The investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation Training (CAT; a psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia ) to existing community treatment (CT) for individuals with schizophrenia in 8 community mental health centers across multiple states including 400 participants. Mechanisms of action will be examined. Participants will be assessed at baseline and 6 and 12 months on measures of functional and community outcome, medication adherence, symptoms, habit formation and automaticity, cognition and motivation.
详细描述
Schizophrenia remains one of the most disabling conditions world-wide with an economic burden that exceeded $155 billion dollars in fiscal year 2013 alone. Despite existing medication and community treatment, many individuals with this diagnosis continue to have poor outcomes and struggle toward recovery. CAT is a psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia, and support habits for functional behavior to promote recovery. In a series of efficacy studies, CAT improved social and occupational functioning, symptoms, and adherence to medication, and reduced rates of readmission. The investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation Training (CAT) to existing community treatment (CT) for individuals with schizophrenia in 8 community mental health centers across multiple states including 400 participants. This would be the first large-scale effectiveness study of CAT for improving functional outcomes for those with schizophrenia seen in community mental health centers (CMHCs) where the majority of those with schizophrenia are followed for outpatient care and to study the purported mechanisms of action based on an integrated theoretical model. Participants will be assessed at baseline and 6 and 12 months on measures of functional and community outcome, medication adherence, symptoms, habit formation and automaticity, cognition and motivation. CAT treatment will be weekly for 6 months, biweekly for 3 months and monthly for the remainder of the trial. Purported mechanisms of action for CAT including bypassing impairments in cognitive function to improve functional outcome and bypassing motivational impairments to create automatic habits to improve functional outcome will be examined.
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
Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims.
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
- •Males and females who have given informed consent.
- •Between the ages of 18 and
- •Clinical Diagnosis of Schizophrenia, or Schizoaffective Disorder
- •Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year.
- •Able to understand and complete rating scales and assessments.
- •Agree to home visits
- •Be able to have reimbursed home visits as part of treatment
排除标准
- •Alcohol or drug or dependence within the past 2 months.
- •Currently being treated by an Assertive Community Treatment (ACT) team.
- •History of assault within the past year or other conditions that in the judgement of the treatment team make home visits unsafe.
结局指标
主要结局
Change in Social and Occupational Functioning Scale Scores
时间窗: baseline, 6 months, 12 months
A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
次要结局
- Change in Multnomah Community Ability Scale mean score(baseline, 6 months, 12 months)
- Change in Daily activity(baseline, 6 months, 12 months)
- Change in Adherence Estimate Score(baseline, 6 months, 12 months)
- Change in Negative Symptom Assessment-16 Mean Score(baseline, 6 months, 12 months)
- Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score(baseline, 6 months, 12 months)
研究者
Dawn Velligan
Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences
The University of Texas Health Science Center at San Antonio
