Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost (TAP)
Triple Aim Psychotherapy: an RCT Comparing Cognitive Behaviour Therapy (CBT) to Adaptive Psychological Training (APT) - a Treatment Aimed at Improving Patient Experience, Population Health, and Cost-effectiveness
研究概览
详细说明
Depression and anxiety are highly prevalent in the general population. Community mental health programs in publically-funded jurisdictions such as Canada often have relatively limited, fixed budgets in order to provide services, which can result in inadequate access to effective treatment for patients. Cognitive Behaviour Therapy (CBT) is a gold-standard psychotherapeutic treatment for depression and anxiety. In order to improve access to treatment, community mental healthcare settings often provide CBT in a group format for patients experiencing mild-to-moderate symptoms. However, typical protocols for delivering group CBT in a community setting nonetheless require a considerable investment of limited clinician time.
The question arises as to whether this is the most efficient and effective use of clinician time; in other words, per hour spent of clinician time, does this approach maximize the number of patients experiencing adequate and meaningful clinical improvement? The Institute for Healthcare Improvement (IHI) developed the Triple Aim, which is a framework describing an approach to optimizing health system performance by simultaneously pursuing three dimensions, namely improving the patient experience of care; improving the health of populations; and reducing the associated per capita costs of care. Studies of psychotherapy rarely pursue all three of these dimensions simultaneously. Efforts to achieve the best clinical outcome for an individual often lead to restrictive inclusionary/exclusionary criteria that sacrifice reaching the wider population; conversely, efforts to improve population health often prioritize composite overall clinical improvement across an entire group, even though the change experienced by many of the individuals in the population might not be clinically meaningful; focusing primarily on cost-effectiveness often sacrifices the individual's experience and/or the population's needs.
Adaptive Psychological Training (APT) is a group-based psychotherapy designed with all of the dimensions of the Triple Aim in mind simultaneously. In its development, APT drew heavily upon Mindfulness-Based Cognitive Therapy, an evidence-based psychotherapy that itself draws upon both evidence-based eastern psychotherapeutic practices and CBT, but APT also drew upon other evidence-based and evidence-supported psychotherapies including interpersonal and relational approaches, as well as meaning-focused psychoanalytic models. It also drew from psychology and neuroscience more broadly, as well as from learning theory and from practical clinical and operational experience. Inclusion/exclusion criteria, group size, number of sessions, in-session practice and learning, and between-session practice and learning were all adapted from the perspective of trying to achieve high quality outcomes for a broader population within more contained costs, and thereby increase access to quality care.
To-date, APT has already demonstrated positive outcomes in pilot research and in community clinical settings. The purpose of this specific study is to determine whether for a given population of patients experiencing mild-to-moderate symptoms of depression and/or anxiety, APT can facilitate meaningful change for more patients per time spent by clinicians than can CBT (the gold standard). The significance of this study includes its potential contribution to determining how best to deploy the limited resource of clinician time in a community setting in order to best help the most people.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Steven Selchen, MD MSt FRCPC
- 电话号码:(905) 681-4812
- 邮箱:dr.steven.selchen@josephbranthospital.ca
研究联系人备份
- 姓名:Benjamin D Diplock, BScH
- 邮箱:ben.diplock@sunnybrook.ca
学习地点
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Ontario
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Burlington、Ontario、加拿大、L7S OA2
- Joseph Brant Hospital
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接触:
- Steven Selchen, MD MSt FRCPC
- 电话号码:(905) 681-4812
- 邮箱:dr.steven.selchen@josephbranthospital.ca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Treatment-seeking adults, interested and willing to participate in group psychotherapy
- Mild-to-moderate depressive (score of ≥10 and <20 on PHQ9) and/or anxious (score of ≥8 and <15 on GAD7) symptoms
- Ability to communicate, in written and spoken English
Exclusion Criteria:
- Severe depressive/anxious symptoms
- Patients where the primary clinical focus is active suicidality or harm-to-others, psychosis, mania, substance use, posttraumatic stress, or personality pathology such that it would interfere with group function
- Recent course(s) of the study psychotherapies
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Cognitive Behaviour Therapy
10 week, manual-based group CBT treatment for depression and anxiety, followed by optional booster sessions
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CBT will be delivered in group format, consisting of 10 weekly two-hour sessions, with 10 participants per group
其他名称:
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有源比较器:Adaptive Psychological Training
5 week, manual-based group APT treatment for depression and anxiety, followed by optional booster sessions
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APT will be delivered in group format, consisting of 5 weekly two-hour sessions, with 20 participants per group
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Triple Aim Measure
大体时间:At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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Numerator: The number of patients achieving reliable recovery; denominator: clinician time spent in hours ('reliable recovery' is defined as scores below 'caseness' for both depression [<10 on Patient Health Questionnaire (PHQ-9)] and anxiety [<8 on Generalized Anxiety Disorder-7 (GAD-7)], with any change from above caseness to below caseness meeting the threshold of the Reliable Change Index)
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At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Triple Aim Measure - recovery only
大体时间:At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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Triple Aim Composite Score (as above), but without the Reliable Change Index requirement
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At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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Triple Aim Measure - improvement only
大体时间:At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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Triple Aim Composite Score (as above), but without the remission requirement
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At 10 weeks; in a secondary fashion, this outcome will also be examined every two weeks across 6 months
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Change from baseline - depressive symptoms
大体时间:Pre- (week 0) and repeated every two weeks across 6 months
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Scale used to measure depressive symptoms is the Patient Health Questionnaire (PHQ-9); score ranges from 0-27, where higher values indicate more depressive symptoms (worse outcome)
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Pre- (week 0) and repeated every two weeks across 6 months
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Change from baseline - anxiety symptoms
大体时间:Pre- (week 0) and repeated every two weeks across 6 months
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Scale used to measure anxiety symptoms is the Generalized Anxiety Disorder 7-item (GAD-7) Scale; score ranges from 0-21, where higher values indicate more anxiety symptoms (worse outcome)
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Pre- (week 0) and repeated every two weeks across 6 months
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Change from baseline - function
大体时间:Pre- (week 0) and repeated monthly across 6 months
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Scale used to measure function is the World Health Organization Disability Assessment Schedule 2.0 - 12 item version (WHODAS 2.0 12-item); score ranges from 0-48, where higher values indicate lower functioning (worse outcome)
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Pre- (week 0) and repeated monthly across 6 months
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Change from baseline - mental wellbeing
大体时间:Pre- (week 0) and repeated monthly across 6 months
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Scale used to measure mental wellbeing is the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); score ranges from 14-70, where higher values indicate greater mental wellbeing (better outcome)
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Pre- (week 0) and repeated monthly across 6 months
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Change from baseline - self-compassion
大体时间:Pre- (week 0) and repeated monthly across 6 months
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Scale used to measure self-compassion is the Self-Compassion Scale - Short Form (SCS-SF); score ranges from 12-60, where higher values indicate greater self-compassion (better outcome)
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Pre- (week 0) and repeated monthly across 6 months
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合作者和调查者
调查人员
- 首席研究员:Steven Selchen, MD MSt FRCPC、Joseph Brant Hospital
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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