1/2 Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial

基于客观睡眠持续时间的 1/2 认知行为疗法和曲唑酮对失眠表型睡眠和血压的影响:序贯队列/随机对照试验

基本信息

项目摘要

PROJECT SUMMARY Insomnia is a prevalent health problem associated with adverse cardiovascular, metabolic, and mental health outcomes. Previously proposed subtypes, based on traditional clinical measures, have poor reliability and validity and have not proven useful for guiding insomnia treatment decisions. Based on a large base of preliminary data from various domains and several investigative groups, we have identified a particular phenotype, insomnia with short sleep duration (ISS), that is associated with increased risk for adverse health outcomes, greater physiological hyperarousal as indicated by hypothalamic-pituitary-adrenal (HPA) axis activation, and worse response to Cognitive-Behavioral Treatment for Insomnia (CBT-I). The proposed study represents the next logical extension of our previous observations: To determine the efficacy of CBT-I in individuals with ISS vs. Insomnia with normal sleep duration (INS) among adults with elevated blood pressure (BP), and to examine the efficacy of trazodone among non-remitters to CBT-I. CBT-I is recommended as first-line treatment for insomnia, and trazodone is a widely-prescribed but grossly understudied medication for insomnia. In addition, our pilot data demonstrate differential efficacy of CBT-I and trazodone in ISS and INS: trazodone, but not CBT-I, increases objective total sleep time (TST), and lowers BP and evening cortisol in ISS. We will conduct a 4-site cohort study followed by a placebo-controlled RCT in 600 adults (≥18y) with insomnia. The cohort study will examine the efficacy of CBT-l among individuals with ISS vs. INS phenotypes (n=300 each), defined by polysomnographic (PSG) TST. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters. Investigators at the 4 study sites (Hershey, Denver, Pittsburg, and Quebec) have a long history of collaboration and successful completion of NIH-funded mechanistic and clinical trial studies. Our primary outcome will be the insomnia remission at 8 weeks, defined as Insomnia Severity Index (ISI) <8; ISI is the gold-standard self-report measure of insomnia symptoms. Secondary outcomes will include ISI (continuous), objective (i.e., PSG and actigraphy) measures of sleep efficiency (in the CBT-I cohort study) and TST, HBP, and evening cortisol (in the trazodone-placebo RCT). In exploratory analyses, we will test whether changes in evening cortisol mediate the effect of trazodone on objective TST and HBP. Outcomes will be assessed at 8 weeks and 6 months following the end of treatment to evaluate the durability of treatment effects. Demonstrating a differential efficacy of CBT-I as a function of insomnia phenotype would aid the goals of precision medicine, which directs therapy on the basis of clinical phenotypes and physiology as well as genetics. Although CBT-I is recommended as first-line treatment for all adults with insomnia, finding a worse response in the ISS phenotype will lead to reconsidering this current guideline in lieu of matching patients’ phenotype to treatment. Demonstrating the efficacy of trazodone among CBT-I non-remitters will fill an obvious and important knowledge gap in insomnia treatment l as it pertains to its current wide-spread off-label use.
项目总结

项目成果

期刊论文数量(0)
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Daniel J. Buysse其他文献

A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the “fit” of psychological treatments by adapting to context
  • DOI:
    10.1186/s13012-025-01440-9
  • 发表时间:
    2025-07-09
  • 期刊:
  • 影响因子:
    13.400
  • 作者:
    Allison G. Harvey;Emma R. Agnew;Rafael Esteva Hache;Julia M. Spencer;Marlen Diaz;Estephania Ovalle Patino;Anne Milner;Lu Dong;Amy M. Kilbourne;Daniel J. Buysse;Catherine A. Callaway;Laurel D. Sarfan
  • 通讯作者:
    Laurel D. Sarfan
Correction to: Subjective and neural reactivity during savoring and rumination
  • DOI:
    10.3758/s13415-023-01145-w
  • 发表时间:
    2024-02-20
  • 期刊:
  • 影响因子:
    2.700
  • 作者:
    Benjamin O. Brandeis;Greg J. Siegle;Peter Franzen;Adriane Soehner;Brant Hasler;Dana McMakin;Kym Young;Daniel J. Buysse
  • 通讯作者:
    Daniel J. Buysse
Alpha-2-adrenergic agonists reduce resting energy expenditure in humans during external cooling
α-2-肾上腺素能激动剂可减少外部冷却期间人体的静息能量消耗
  • DOI:
    10.1080/23328940.2024.2339781
  • 发表时间:
    2024
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Clifton W. Callaway;Katharyn L Flickinger;Alexandra Weissman;Francis X. Guyette;Ryann DeMaio;Andrea Jonsson;Victor Wu;Jenna L. Monteleone;Peter Prescott;Jonathan Birabaharan;Daniel J. Buysse;P. Empey;Thomas D. Nolin;Raymond E. West
  • 通讯作者:
    Raymond E. West
総合病院精神科におけるアルコール健康障害への取り組みと、「減酒外来」について
综合医院精神科和“戒酒门诊”致力于治疗酒精相关疾病
  • DOI:
  • 发表时间:
    2021
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Ryuji Furihata;Yukiko Tateyama;Yukako Nakagami;Toshiki Akahoshi;Osamu Itani;Yoshitaka Kaneita;Daniel J. Buysse;角南隆史
  • 通讯作者:
    角南隆史
Sleep intervention and glycemic control in gestational diabetes mellitus: a feasibility study
妊娠期糖尿病中的睡眠干预与血糖控制:一项可行性研究
  • DOI:
    10.1016/j.ajogmf.2022.100836
  • 发表时间:
    2023-02-01
  • 期刊:
  • 影响因子:
    3.100
  • 作者:
    Roxanna M. Twedt;Daniel J. Buysse;Peter L. Franzen;Megan E. Hamm;Francesca L. Facco
  • 通讯作者:
    Francesca L. Facco

Daniel J. Buysse的其他文献

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{{ truncateString('Daniel J. Buysse', 18)}}的其他基金

Pragmatic trial of behavioral interventions for insomnia in hypertensive patients
高血压患者失眠行为干预的实用性试验
  • 批准号:
    9125875
  • 财政年份:
    2014
  • 资助金额:
    $ 185.17万
  • 项目类别:
Pragmatic trial of behavioral interventions for insomnia in hypertensive patients
高血压患者失眠行为干预的实用性试验
  • 批准号:
    8792640
  • 财政年份:
    2014
  • 资助金额:
    $ 185.17万
  • 项目类别:
Pragmatic trial of behavioral interventions for insomnia in hypertensive patients
高血压患者失眠行为干预的实用性试验
  • 批准号:
    9325558
  • 财政年份:
    2014
  • 资助金额:
    $ 185.17万
  • 项目类别:
Dimensional Sleep Disturbance in Relation to Positive/Negative Affect Systems
与积极/消极情感系统相关的维度睡眠障碍
  • 批准号:
    8765960
  • 财政年份:
    2014
  • 资助金额:
    $ 185.17万
  • 项目类别:
Aging Well, Sleeping Efficiently
延年益寿,高效睡眠
  • 批准号:
    8665845
  • 财政年份:
    2010
  • 资助金额:
    $ 185.17万
  • 项目类别:
2/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants
2/3-通过在抗抑郁药中添加治疗失眠的 CBT 来改善抑郁症的结果
  • 批准号:
    8255615
  • 财政年份:
    2008
  • 资助金额:
    $ 185.17万
  • 项目类别:
2/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants
2/3-通过在抗抑郁药中添加治疗失眠的 CBT 来改善抑郁症的结果
  • 批准号:
    7817029
  • 财政年份:
    2008
  • 资助金额:
    $ 185.17万
  • 项目类别:
2/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants
2/3-通过在抗抑郁药中添加治疗失眠的 CBT 来改善抑郁症的结果
  • 批准号:
    8071232
  • 财政年份:
    2008
  • 资助金额:
    $ 185.17万
  • 项目类别:
2/3-Improving Depression Outcome by Adding CBT for Insomnia to Antidepressants
2/3-通过在抗抑郁药中添加治疗失眠的 CBT 来改善抑郁症的结果
  • 批准号:
    7626661
  • 财政年份:
    2008
  • 资助金额:
    $ 185.17万
  • 项目类别:
Translational Research Training in Sleep Medicine
睡眠医学转化研究培训
  • 批准号:
    8213306
  • 财政年份:
    2007
  • 资助金额:
    $ 185.17万
  • 项目类别:

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Association between maternal serum fatty acids levels during mid pregnancy and blood pressure of offsprings at 8 years of age
妊娠中期母亲血清脂肪酸水平与后代8岁时血压之间的关系
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与年龄相关的血压、脉率变化以及这些与年龄相关的日常变化的预后价值
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