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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要患双相情感障碍 (BP) 的最有力的危险因素是一级家庭成员患有双相情感障碍 (BP) 该疾病；有家族史的人通常会出现早期血压升高和严重病程（高达 25%）。使用来自 BP (OBP) 的父母的后代在成年后患上 BP 的纵向数据。匹兹堡双相情感障碍后代研究 (BIOS MH60952)，我们开发了一种临床工具（“风险计算器”），使用人口统计和临床变量的子集可靠地预测个体 OBP 的 5 年 BP 风险。这项创新提供了理想的机会来识别 OBP 的最大风险并提供指示性预防措施然而，迄今为止，还没有针对尚未发生 OBP 的循证干预措施。根据实验治疗框架，有希望的方法应该是：和目标、导致和维持疾病的因素。证据表明了高血压的发生途径。生理上脆弱的青少年涉及睡眠和昼夜节律紊乱。社交节律疗法 (IPSRT)，一种针对成人血压的循证治疗方法，有助于稳定睡眠/ 在一项开放试点和随后的 R34 随机试验 (MH091177) 中，针对青少年 OBP 的昼夜节律模式。我们通过 OBP 建立了 IPSRT 的初步疗效信号。我们的数据进一步表明了 IPSRT，但并非如此。社区治疗转介 (CTR)，参与并改变已开发的行动机制——睡眠/ 尽管实际障碍影响了治疗就诊率，但昼夜节律紊乱。该研究计划的下一步至关重要：通过远程医疗提供 IPSRT 的验证性疗效试验通过风险计算器评分，OBP（12-18 岁，n=120）的 BP 发病风险较高。精神症状和睡眠障碍的基线临床评估（通过客观和主观方法），然后进行反馈会议，然后将青少年随机接受 8 次 IPSRT 或一次反馈会议。通过安全视频会议提供手动健康生活方式行为计划 (HL)，以增强根据临床表明，青少年可以接受针对任何精神症状/疾病的 CTR。 18 个月内确定的主要结果领域包括阈下躁狂和情感。不稳定性--OBP 中 BP 的 2 个有效的近期预测因子，它们本身与发病率和我们还将进一步研究所探索的 IPSRT-睡眠/昼夜节律的机制。颠覆——使用可靠、具有成本效益的方法（体动记录仪和每日日记）进行跨层次的分析评级），以及人际压力对睡眠/昼夜节律紊乱的影响。如果有效的话，实施科学方法可以最大限度地提高最终的可扩展性和可行性。还将研究无源手机传感是否可以作为一种便携式、具有成本效益的措施加强该领域研究的机制和成果有潜力预防、延缓或改善高危人群罹患这种慢性毁灭性疾病的进展。