Recovery Oriented Cognitive Therapy (CT-R) Medication Checks: An Acceptability and Feasibility Trial, Standard Operating Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Mental Illness Research Education and Clinical Center (MIRECC) Global Assessment of Functioning (GAF)
研究概览
简要总结
The goal of this feasibility and acceptability trial is to learn about the acceptability of adding a recovery-oriented, psychological framework to a standard medication management appointment with a psychiatrist and any impact on attendance and functioning. The main question[s] it aims to answer are:
- Will CT-R medication checks will be acceptable to the patient and feasible to deliver and receive, as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs?
- Will CT-R medication checks will be related to significantly greater engagement with treatment as measured by: lower no-show rates, greater self-reported working alliance, and better treatment adherence?
- Will CT-R medication checks will be related to greater activity and increase in functioning as measured by: time use survey, GAF, skill use?
- Will CT-R medication checks will be related to a trend in improved defeatist beliefs, negative symptoms, paranoia, and self-esteem?
Researchers will compare the group assigned to the trial psychiatrists to a small group who were assigned to non-trial psychiatrists to see if the intervention impacted any of the above questions beyond TAU.
详细描述
The current study aims to test whether adapting a psychological treatment for schizophrenia to medication appointments with psychiatry residents is acceptable and feasible, and whether it improves treatment engagement, functioning and symptom burden, particularly negative symptoms. In addition to providing psychiatry residents with a framework for conducting medication appointments, it will also give patients with psychotic disorders access to empirically-supported psychological interventions, that they may not otherwise have access to. We will test the acceptability and feasibility of this adapted intervention and examine whether effect sizes of change with intervention in this sample size warrant testing in a larger study.
Only patients who consent to being in the study will receive CT-R medication appointments. CT-R is a therapy process that is being implemented within the medication appointments. The provided measures and tasks are outcomes to be measured throughout the study. For instance, we are interested in how clinical symptoms, subjective well-being, and treatment engagement change with the implementation of CT-R in medication appointments.
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CT-R medication checks will be acceptable to the patient and feasible to deliver and receive, as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs.
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CT-R medication checks will be related to significantly greater engagement with treatment as measured by: lower no-show rates, greater self-reported working alliance, and better treatment adherence
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CT-R medication checks will be related to greater activity and increase in functioning as measured by: time use survey, GAF, skill use
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CT-R medication checks will be related to a trend in improved defeatist beliefs, negative symptoms, paranoia, and self-esteem
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Exploratory analyses will include:
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CT-R med checks will be related to greater improvement on a cognitive motivation task (EEfRT/Balloon task)
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Improvement in Defeatist Belief Scale (DBS) and Neg Symptoms will be mediated by increased treatment adherence, engagement and activity
Expected study duration: 3 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Schizophrenia-spectrum disorder
- •Typically scheduled 1x/month
- •Willingness to complete 2-3 hours of testing at multiple timepoints
- •Likely to stay in our clinic for the next 1-2 years
排除标准
- •Significant intellectual disability
- •Autism spectrum disorder
- •Cannot read/write English
结局指标
主要结局
Mental Illness Research Education and Clinical Center (MIRECC) Global Assessment of Functioning (GAF)
时间窗: Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)
Standardized Measure of overall functioning; Scored from 0-100 with higher score indicating better functioning. Scoring is based on predetermined parameters.
Working Alliance Inventory
时间窗: Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)
Measure of patient perception of working alliance
Time Use Interview
时间窗: Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)
Interview capturing amount of time in productive activity.
Compass
时间窗: Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)
Interview of symptoms and their severity.
次要结局
- Defeatist Beliefs Scale(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- Cognitive Insight Scale(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- Questionnaire about the Process of Recovery (QPR)(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- Asocial Beliefs Scale(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- Green Paranoid Thoughts Scale(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- Self Esteem Scale(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
- SOLES(Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months))
研究者
Aaron Brinen
Assistant Professor of Psychiatry and Behavioral Sciences
Vanderbilt University Medical Center