Augmenting the Efficacy of Benzodiazepine Taper with Telehealth-Delivered Cognitive Behavioral Therapy for Anxiety Disorders in Patients Using Prescription Opioids

通过远程医疗提供的认知行为疗法来增强苯二氮卓类药物逐渐减少的疗效，以治疗使用处方阿片类药物的焦虑症患者

• 批准号: 10355810
• 负责人: Larissa Jeanette Mooney
• 金额: $ 19.78万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10355810
• 关键词: Address; Adherence; Aftercare; Anxiety; Anxiety Disorders; Benzodiazepines; Cells; Clinic; Clinical Research; Clinical Trials; Cognitive Therapy; Data; Dissemination and Implementation; Dose; Drug Screening; Ensure; Feedback; Focus Groups; Goals; Health education; Individual; Intervention; Measures; Mediating; Medical; Mental Depression; Minor; Opioid; Overdose; Pain; Pain Disorder; Panic Disorder; Participant; Patient Care; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Physicians; Population; Primary Care Physician; Primary Health Care; Protocols documentation; Provider; Psychiatry; Psychology; Public Health; Randomized; Randomized Clinical Trials; Reporting; Research; Resources; Risk; Severities; Signal Transduction; Standardization; Symptoms; System; Time; Treatment outcome; United States Food and Drug Administration; Urine; Work; anxiety sensitivity; anxiety symptoms; arm; care coordination; comorbidity; effective therapy; eligible participant; follow up assessment; follow-up; high risk; high risk population; innovation; mortality; mortality risk; opioid use; opioid use disorder; opioid user; overdose death; pain catastrophizing; patient population; prescription opioid; primary care setting; recruit; reduce symptoms; remote visit; satisfaction; symptom treatment; telehealth; treatment effect; treatment of anxiety disorders; treatment program

Project Summary Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth- delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post- treatment, and at a 3-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.

项目摘要 将处方阿片类药物与苯二氮卓类药物一起用于治疗焦虑症， 美国食品和药物管理局（FDA）推荐，因为严重的风险增加 并发症，包括致命的服药过量。然而，这种同时处方使用仍然很普遍， 可能是因为疼痛和焦虑症之间的高共病率。迫切需要努力减少 服用阿片类药物的患者中苯二氮卓类药物的使用。认知行为疗法（CBT）是一线治疗方法， 对于焦虑症来说，这是一种更安全，更有效的治疗焦虑症的方法， 苯二氮卓类拟议的研究旨在对CBT协议进行小幅调整，以促进 苯二氮卓类药物逐渐减量，然后在初级保健患者中进行2组随机临床试验， 接受苯二氮卓类药物和阿片类药物处方。参与者将随机接受远程医疗- 提供干预，包括温和的，12周的苯二氮卓类药物减量（BZT）与CBT或健康 教育控制（HE）。参与者将在基线、整个治疗期间的几个点、治疗后的几个点和治疗后的几个点进行评估。 治疗，并在3个月的随访评估苯二氮卓类药物的使用，阿片类药物的使用和焦虑症状。 如果CBT + BZT优于HE + BZT，这种干预可以通过减少主要的 同时使用阿片类药物和苯二氮卓类药物的后果，包括死亡率。