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？

• 批准号: 7953505
• 负责人: YAN LEYKIN
• 金额: $ 17.83万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953505
• 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; 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 Ethics Committees; Research Personnel; Risk; Safety; Severities; Social Network; Social support; Source; Stigmata; 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

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）：重度抑郁症（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抑郁症的有效治疗方法。临床试验参与者的安全性由机构审查委员会（IRB）监督。对抑郁症患者是否有能力就参与研究做出明智的决定的担忧一直是争论的焦点。许多人，包括IRB审查员，认为精神障碍会影响决策。然而，在研究背景下，抑郁症患者的决策能力的经验数据是很少的。因此，IRB必须根据公认的“智慧”而不是经验证据提出建议。这可能导致IRB关于抑郁个体适当保护水平的建议存在差异。虽然存在评估个人作出知情同意的能力的工具，但这些工具只能确定一个人是否知道如何作出决定，而不能确定一项决定是否符合一个人的偏好，是否符合他或她的最大利益。因此，抑郁症是否影响决策质量的问题仍然没有得到解决。 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选择适当程度的保障措施的抑郁症患者参加研究。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对假设临床试验风险和获益评估的影响。将检查抑郁个体所做的决定是否与他们对更好的健康状态的偏好一致，并与慢性疼痛（一种致残性非精神疾病）、MDD和疼痛共病个体所做的决定以及健康对照的决定进行比较。本研究是响应NIMH战略目标3和4。这项研究的结果有可能简化涉及抑郁症患者的研究，为主要利益相关者提供数据，这些数据要么支持需要额外的保护，要么确定不需要额外的保障措施。它可能揭示了抑郁症患者在决策过程中遇到的困难，从而提供了一个新的干预重点。 该项目描述了一个为期五年的计划，在劳拉·邓恩博士的指导下发展心理学学术生涯，她在生物伦理学和与提供知情同意能力相关的问题方面拥有丰富的经验。此外，共同导师Ricardo Muqoz博士将就该项目与抑郁症有关的方面提供指导，顾问Jonathan Baron博士将提供决策方面的援助和培训。最终，该项目将允许建立一个调查线，将精神病理学和决策结合在一个相互信息的关系中;该奖项所提供的科学发展将提供成为一个成功的独立调查员所需的技能。 公共卫生相关性：尽管有关抑郁个体决策能力的数据很少，但许多人，包括那些受委托保护抑郁研究参与者的人，都认为抑郁会损害对研究参与做出明智决定的能力。该项目将研究抑郁症患者所做决定的质量，并检查他们是否会做出非精神疾病患者所不会做出的决定。这项调查的结果将提供所需的数据，以确定适当的水平和类型的保护和保障措施，为抑郁症患者参加研究。