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Does depression affect quality of decisions to participate in clinical trials?

抑郁症会影响参与临床试验的决策质量吗？

基本信息

批准号：
8643821
负责人：
YAN LEYKIN
金额：
$ 17.65万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-01 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8643821
关键词：
Affect Award Benefits and Risks Bioethics Characteristics Charge Clinical Clinical Research Clinical Trials Combat Disorders Data Decision Making Depressed mood Development Disease Enrollment Ensure Ethics Evaluation Gambling Health Individual Informed Consent Institutional Review Boards Intervention Investigation Judgment Light Major Depressive Disorder Measures Medical Mental Depression Mental disorders Mentors Mentorship National Institute of Mental Health Pain Participant Patients Perception Personal Satisfaction Persons Population Process Psychology Psychopathology Recommendation Recording of previous events Recruitment Activity Relative (related person)Research Research Activity Research Design Research Ethics Research Personnel Risk Safety Severities Social Network Social support Source Time Training Treatment Failure Variant Vulnerable Populations base career chronic pain design disability effective therapy experience health economics improved innovation instrument interest patient safety physical conditioning preference programs public health relevance skills social social stigma tool

项目摘要

DESCRIPTION (provided by applicant): Major depressive disorder (MDD) is one of the most prevalent and debilitating mental disorders in the world. Clinical trials recruiting depressed individuals are instrumental in the development and evaluation of effective treatments for depression. The safety of participants in clinical trials is overseen by the Institutional review boards (IRBs). Concerns about abilities of people with depression to make an informed decision about research participation have been an ongoing source of debate. Many, including IRB reviewers, presume that mental disorders compromise decision-making. However, empirical data regarding decision-making abilities of depressed persons in research context are scant. IRBs must therefore make recommendations based on accepted "wisdom" rather than empirical evidence. This likely results in the variability in recommendations of IRBs regarding the appropriate level of protection of depressed individuals. Whereas instruments assessing the individuals' capacity to give informed consent exist, they can only determine whether a person knows how to make a decision, but not whether a decision is consistent with a person's preferences and is in his or her best interest. Thus, the question of whether depression affects the quality of decisions remains unaddressed. The proposed project aims to provide data that will ultimately help those entrusted with the well-being of research participants to select appropriate degree of safeguards for depressed individuals enrolling in research. This will be accomplished by using tools from health economics and health decision-making to understand the influence of MDD on the evaluation of risks and benefits of hypothetical clinical trials. Decisions made by depressed individuals will be examined for consistency with their preferences for better health states, and compared to decisions made by individuals with chronic pain (a comparably disabling non-psychiatric condition), with comorbid MDD and pain, and to decisions of healthy controls. This research is responsive to NIMH Strategic Objectives 3 and 4. Results of this study have the potential to streamline research involving depressed persons by providing major stakeholders the data which either supports the need for additional protection, or determines that no additional safeguards are necessary. It may shed light on the difficulties depressed individuals experience with decision-making, thereby providing a new focus of interventions. This project describes a five-year program to develop an academic career in psychology under the mentorship of Dr. Laura Dunn, who has extensive experience in bioethics and issues related to capacity to provide informed consent. In addition, Dr. Ricardo Muqoz, a co-mentor, will provide guidance on aspects of the project related to depression, and Dr. Jonathan Baron, a consultant, will provide assistance and training in decision-making. Ultimately, this project will allow the establishment of a line of inquiry combining psychopathology and decision-making in a mutually informative relationship; the scientific development afforded by this award will provide the skills necessary to become a successful independent investigator. PUBLIC HEALTH RELEVANCE: Despite scant data about decision-making abilities of depressed individuals, many, including those entrusted with the protection of depressed research participants, presume that depression compromises the abilities to make an informed decision about research participation. This project will study the quality of decisions made by depressed individuals, and examine whether they make decisions that those with a non-psychiatric disorder do not. Results of this investigation will provide data needed to determine the appropriate level and types of protection and safeguards for depressed individuals enrolling in research.

描述(由申请人提供)：严重抑郁障碍(MDD)是世界上最普遍和最令人衰弱的精神障碍之一。招募抑郁症患者的临床试验有助于开发和评估有效的抑郁症治疗方法。临床试验参与者的安全性由机构审查委员会(IRBs)监督。对抑郁症患者做出关于参与研究的知情决定的能力的担忧一直是争论的来源。包括IRB审查员在内的许多人认为，精神障碍会影响决策。然而，关于抑郁症患者在研究背景下的决策能力的经验数据很少。因此，国际评级机构必须根据公认的“智慧”而不是经验证据提出建议。这很可能导致IRBs对抑郁症患者的适当保护水平的建议不尽相同。虽然存在评估个人给予知情同意的能力的工具，但它们只能确定一个人是否知道如何做出决定，而不能确定决定是否符合一个人的偏好并符合他或她的最佳利益。因此，抑郁症是否会影响决策质量的问题仍未得到解决。拟议的项目旨在提供数据，最终帮助那些受托为研究参与者的福祉负责的人为参加研究的抑郁症患者选择适当程度的保障措施。这将通过使用卫生经济学和卫生决策的工具来实现，以了解MDD对假设性临床试验的风险和收益评估的影响。抑郁症患者的决定将被检查是否与他们对更好健康状态的偏好一致，并与患有慢性疼痛(一种类似于致残的非精神疾病)、患有MDD和疼痛的个人以及健康对照组的决定进行比较。这项研究是对NIMH战略目标3和4的响应。这项研究的结果有可能通过向主要利益攸关方提供数据来简化涉及抑郁症患者的研究，这些数据要么支持额外保护的必要性，要么确定不需要额外的保障措施。它可能会揭示抑郁个体在决策过程中遇到的困难，从而提供一个新的干预重点。这个项目描述了一个在劳拉·邓恩博士的指导下发展心理学学术生涯的五年计划，劳拉·邓恩博士在生物伦理学和与提供知情同意的能力相关的问题上拥有丰富的经验。此外，共同导师里卡多·穆科兹博士将就该项目与抑郁症相关的方面提供指导，顾问乔纳森·巴伦博士将提供决策方面的帮助和培训。最终，这一项目将允许建立一条调查路线，在相互提供信息的关系中结合精神病理学和决策；这一奖项所提供的科学发展将提供成为一名成功的独立调查人员所需的技能。与公共健康相关：尽管关于抑郁症个人决策能力的数据很少，但许多人，包括那些受托保护抑郁症研究参与者的人，认为抑郁症损害了就参与研究做出知情决定的能力。这个项目将研究抑郁症患者所做决定的质量，并考察他们是否做出了非精神障碍患者所不做的决定。这项调查的结果将提供必要的数据，以确定为参加研究的抑郁症个人提供适当水平和类型的保护和保障措施。