Early Intervention for Youth At-Risk for Bipolar Disorder

对有双相情感障碍风险的青少年进行早期干预

• 批准号: 10645138
• 负责人: TINA R GOLDSTEIN
• 金额: $ 64.41万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10645138
• 关键词: Adolescence; Adult; Advisory Committees; Affect; Affective; Age; Area; Behavior; Biological Markers; Bipolar Disorder; Brain Diseases; Cellular Phone; Child; Chronic; Chronic Disease; Circadian Dysregulation; Circadian Rhythms; Clinical; Clinical assessments; Communities; Data; Data Collection; Development; Dimensions; Disease; Early Intervention; Evidence based intervention; Evidence based treatment; Exhibits; Family; Family member; Feedback; Health Care Costs; Impairment; Individual; Intake; Intervention; Investigational Therapies; Manic; Manuals; Measurable; Measures; Mediating; Meta-Analysis; Methods; Mood Disorders; Moods; Morbidity - disease rate; National Institute of Mental Health; Onset of illness; Outcome; Outcome Study; Parents; Participant; Pathway interactions; Patient Self-Report; Pattern; Prevention; Prevention approach; Psychopathology; Public Health; Randomized; Recording of previous events; Reporting; Research; Risk; Risk Factors; Role; Secure; Severity of illness; Signal Transduction; Sleep; Sleep disturbances; Strategic Planning; Stress; Suicide; Symptoms; Telephone; Testing; Time; Visit; Vulnerable Populations; Youth; actigraphy; adolescent offspring; anxiety symptoms; circadian; confirmatory trial; cost effective; cost effective measures; depressive symptoms; diaries; disorder risk; early experience; early onset; efficacious intervention; efficacy evaluation; functional disability; healthy lifestyle; high risk; high risk population; implementation science; improved; improvement on sleep; indicated prevention; innovation; modifiable risk; novel strategies; offspring; portability; preempt; prevent; primary outcome; programs; progression risk; psychiatric symptom; randomized trial; social; substance use; suicidal; suicide rate; telehealth; theories; tool; treatment adherence; treatment optimization; treatment response; videoconference; young adult

Project Summary The most potent risk factor for the development of bipolar disorder (BP) is a first-degree family member with the illness; individuals with family history typically experience early BP onset and severe course. Up to 25% of offspring of parents with BP (OBP) develop BP by young adulthood. Using longitudinal data from the Pittsburgh Bipolar Offspring Study (BIOS MH60952), we developed a clinical tool (“risk calculator”) that reliably predicts an individual OBP’s 5-year risk for BP using a subset of demographic and clinical variables. This innovation offers the ideal opportunity to identify OBP at greatest risk and deliver indicated preventive interventions. Yet, to date, there is no evidence-based intervention for OBP who have not already developed mood disorder. Per the experimental therapeutics framework, promising approaches should be informed by, and target, factors that cause and sustain illness. Evidence suggests the pathway to develop BP among biologically vulnerable youth involves sleep and circadian disturbances. We adapted Interpersonal and Social Rhythm Therapy (IPSRT), an evidence-based treatment for BP adults that helps stabilize sleep/ circadian patterns, for adolescent OBP. In an open pilot and subsequent R34 randomized trial (MH091177), we established a preliminary efficacy signal for IPSRT with OBP. Our data further indicate IPSRT, but not Community Treatment Referral (CTR), engages and alters the hypothesized mechanism of action--sleep/ circadian disturbance, although practical barriers impacted treatment attendance. This proposal represents a vital next step in this program of research: a confirmatory efficacy trial of IPSRT delivered via telehealth for OBP (age 12-18, n=120) at elevated risk for BP onset via risk calculator score. All participants receive a baseline clinical assessment of psychiatric symptoms and sleep disturbance (via objective and subjective methods), followed by a feedback session. Youth are then randomized to receive 8 sessions of IPSRT or a manualized Healthy Lifestyle Behaviors Program (HL) delivered via secure videoconference to enhance attendance and reach. As clinically indicated, youth are offered CTR for any psychiatric symptoms/disorders identified at intake. Primary outcome domains over 18 months include subthreshold mania and affective lability--2 potent near-term predictors of BP in OBP that are themselves associated with morbidity and impairment. We will also further investigate the hypothesized mechanism underlying IPSRT-sleep/circadian disruption--across levels of analysis using reliable, cost-effective methods (actigraphy and daily diary ratings), and the contribution of interpersonal stress to sleep/circadian disruptions. Application of Implementation Science methods throughout maximizes ultimate scalability and feasibility if efficacious. We will also examine whether passive cellphone sensing may serve as a portable, cost-effective measure of mechanisms and outcomes to enhance ultimate dissemination. Research in this area has the potential to prevent, delay, or ameliorate the progression of this chronic and devastating illness in those at highest risk.

项目摘要 躁郁症（BP）发展的最潜在危险因素是一级家庭成员 疾病；具有家族史的人通常会经历早期的BP发作和严重的课程。高达25％ BP（OBP）父母的后代由年轻成年发展。使用来自 匹兹堡双极后代研究（BIOS MH60952），我们开发了一种临床工具（“风险计算器”） 可靠地预测，使用人口统计和临床变量的子集，单个OBP的BP风险为5年。 这项创新提供了理想的机会，以最大的风险识别OBP并提供指示的预防性 干预措施。但是，迄今为止，尚未开发出OBP的基于证据 情绪障碍。根据实验疗法框架，应告知承诺方法 目标是导致和维持疾病的因素。有证据表明在中间发展BP的途径 生物脆弱的青年涉及睡眠和昼夜节律障碍。我们改编了人际关系 社交节奏疗法（IPSRT），这是一种针对BP成年人的循证治疗，有助于稳定睡眠/ 昼夜节律模式，适用于青春期的OBP。在开放的飞行员和随后的R34随机试验（MH091177）中， 我们用OBP建立了IPSRT的初步有效性信号。我们的数据进一步指示IPSRT，但没有 社区治疗转诊（CTR），参与并改变了动作的假设机制 - 袖子/ 昼夜节律灾难，尽管实际障碍影响了治疗的出勤率。该提案代表 这项研究计划的下一步至关重要：通过远程医疗提供的IPSRT的确认有效试验 OBP（12-18岁，n = 120），通过风险计算器评分出现BP的风险升高。所有参与者都会收到 基线临床评估精神症状和睡眠障碍（通过客观和主观） 方法），然后进行反馈会话。然后，年轻人被随机接受8个会议ipsrt或一个会议 通过安全视频会议提供的手动健康生活方式行为计划（HL）以增强 出勤率和到达。如临床上所示，为任何精神病症状/疾病提供了CTR的年轻人 在摄入量中确定。在18个月内的主要结果领域包括亚阈值和情感 不稳定-2 OBP中BP的潜在近期预测因素本身与发病率和发病率有关 损害。我们还将进一步研究IPSRT-Sleep/Cirigadian的假设机制 破坏 - 使用可靠的，具有成本效益的方法（行为和日记 评分），以及人际压力对睡眠/昼夜节律干扰的贡献。应用 实施科学方法始终可以最大程度地延伸性和可行性。我们 还将检查被动手机传感是否可以作为便携式，具有成本效益的测量 增强最终传播的机制和结果。该领域的研究有可能 预防，延迟或改善这种慢性病和毁灭性疾病的进展。