Clinical Core

临床核心

• 批准号: 10456006
• 负责人: BRUCE R ROSEN
• 金额: $ 42.74万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456006
• 关键词: Accelerometer; Adherence; Adverse effects; Advertisements; Age; Anxiety; Audiotape; Auras; Awareness; Back; Behavior; Biostatistics Core; Centers of Research Excellence; Chronic Disease; Clinical; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Compassion; Complementary Health; Data; Data Reporting; Devices; Dose; Ecological momentary assessment; Education; Effectiveness; Emergency Situation; Enrollment; Ensure; Exclusion Criteria; Experimental Designs; Female; Frequencies; Gender; Goals; Good Clinical Practice; Headache; Health Alliance; Health education; Individual; Institutional Review Boards; Integrative Medicine; Intervention; Intervention Studies; Measurement; Measures; Mediation; Medical; Menstrual cycle; Mental Depression; Methodology; Migraine; Mindfulness Training; Monitor; Outcome; Pain interference; Patient Self-Report; Patients; Physicians; Premenopause; Protocol Compliance; Protocols documentation; Psychologist; Quality of life; Randomized; Recurrence; Research; Safety; Self Efficacy; Supervision; Training; Training and Education; Transcutaneous Electric Nerve Stimulation; afferent nerve; arm; base; body-mind; chronic pain; clinically relevant; data registry; design; disability; effectiveness study; emotion dysregulation; experience; human subject; mindfulness; mindfulness meditation; mindfulness-based stress reduction; multi-component intervention; perceived stress; recruit; respiratory; trait; vagus nerve stimulation

The  Clinical  Core  (CC)  of  the  Center  of  Excellence  for  Research  on  Complementary  and  Integrative  Health  (CERCIH)  will  facilitate  the  clinical  activities  of  the  three  proposed  Projects,  providing  support  and  expertise  to  unify  all  clinical  aspects  of  our  human  subjects  experimental  designs.    The  CC  will  recruit,  screen,  characterize,  and  enroll  120  subjects  with  recurrent  migraine  headaches  and  30  age-­  and gender-­matched healthy controls.  Mostly using physician referrals and our Research Patient Data  Registry (RPDR), the core will utilize a highly skilled and experienced team to supervise and implement  these  goals.  The  CC  will  be  the  central  randomization  point  for  Projects  1,  2,  and  3  and  provide  the  network  and  referrals  to  support  recruitment  of  all  subjects  and  ensure  adherence  to  the  common  inclusion/exclusion  criteria  utilized  for  all  three  Projects.  The  CC  will  randomize  subjects  using  a  2  x  2  design:  Mindfulness-­Based  Stress  Reduction  (MBSR)  versus  Health  Education  Training  (HET)  X  transcutaneous vagus nerve stimulation (tVNS) compared to sham tVNS.  The CC will ensure that the  MBSR and HET are delivered correctly and adhere to protocol. The CC will recruit, train and supervise  the  MBSR  group  leaders  who  will  perform  all  of  the  necessary  trainings  and  education  sessions.  The  CC  will  refine  and  implement  the  methodologies,  including  audiotaping  and  fidelity  rating  of  training  sessions,  to  ensure  group  leader  protocol  compliance.  The  CC  will  use  accelerometer-­based,  ecologic  momentary  assessment  to  measure  mindfulness  practice  dose  during  the  study  so  as  to  ensure  accurate  measurement  of  individual  subjects’  level  of  mindfulness  practice.    The  CC  will  oversee  and  integrate  our  respiratory-­gated  tVNS  approach  with  MBSR  and  HET  sessions,  including  the  sham  tVNS,  where  needed.  The  CC  will  ensure  that  devices  will  be  available  to  accommodate  all  subjects  and  that  the  units  are  reliably  utilized  within  each  session.    In  collaboration  with  the  biostatistics  core,  the  CC  will  collect  self-­report  measures  to  investigate  relevant  clinical  correlates  such  as  headache  frequency and intensity, days of lost function, perceived stress, and pain interference. The CC will also  collect  self-­report  data  for  mediation  and  moderation  analyses,  including  chronic  disease  self-­efficacy,  perceived  control,  anxiety,  depression,  trait  mindfulness,  mindfulness  practice  behaviors,  self-­ compassion,  interoceptive  awareness,  and  emotional  dysregulation.    While  infrequent,  the  CC  will  be  available  to  provide  medical  coverage  and  assessment  for  any  medical  or  psychiatric  adverse  effect  from tVNS and/or mindfulness.  The CC will meet once per year with the Data Safety Monitoring Board  to  review  and  discuss  any  new  internal  or  pertinent  external  data,  as  well  as  to  monitor  safety,  effectiveness,  and  study  conduct.    The  CC  will  also  coordinate  any  necessary  independent  monitoring  activities as required, and successfully manage one common IRB across the 3 projects.

临床核心（CC）卓越中心的研究互补和整合