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Comparative effectiveness of mindfulness-based stress reduction and pharmacotherapy for anxiety
Investigator (PI): Hoge, Elizabeth
Performing Organization (PO): (Current): Georgetown University, School of Medicine, Department of Psychiatry / (202) 944-5369
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/CER-2017C1-6522
Funding: Total Award Amount: $2,824,840
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Individuals with anxiety disorders experience significant distress and suffering, have impairment in social and occupational functioning, and are at increased risk for suicide. Treatment with medication is the standard treatment for anxiety disorders, but many individuals do not want to take psychiatric medication or go to a psychiatric clinic for care due to stigma and other factors. In recent years, there has been a tremendous growth of patient interest in complementary and alternative medicine for many conditions, including anxiety. Mindfulness meditation treatments have been growing in popularity and becoming widely disseminated, and people with anxiety are interested in mindfulness. A benefit of mindfulness interventions is that they can be provided outside of a mental health setting, which may make them more acceptable to patients. Although mindfulness meditation is gaining popularity, there is no information how this treatment strategy compares with standard treatment, such as with medication. Patients need more information about the comparison of treatments to be able to make informed decisions about their health care. We propose the first randomized, controlled study to assess the comparative effectiveness of mindfulness-based stress reduction (MBSR) compared to escitalopram, a standard medication for patients with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia. Patients will be randomized into two 8-week treatments: (1) MBSR and (2) escitalopram. To enroll the necessary sample, we will utilize three study sites in different geographic locations that each have strong clinical and research infrastructures: Georgetown University Medical Center, Massachusetts General Hospital, and New York University Langone Medical Center. Thus, we will take advantage of three productive teams with previous successful collaborations and experience in mind-body treatment studies. Our patient partners and other stakeholders will help make the project successful by being involved in every stage of the study. They have already helped decide important patient-centered outcomes for this study: effects of the treatments on psychological and physiological symptoms of anxiety, measurements of side effects of treatments, quality of life, sleep quality, worry, satisfaction with treatment, and improvements in social and occupational disability. We will continue to collaborate with our patient partners and stakeholders from health care systems, patient advocacy organizations, and hospital administration, who will continue to advise us during the course of the study through regular meetings and teleconferences on decisions about further outcome measures, study planning and procedures, dissemination and implementation, and making the trial feasible, interesting, and satisfying for patients.
MeSH Terms:
  • Anxiety Disorders /*drug therapy
  • /*therapy
  • Citalopram /*therapeutic use
  • Comparative Effectiveness Research
  • Decision Making
  • District of Columbia
  • Drug Therapy /methods
  • Health Services Research
  • Humans
  • Massachusetts
  • * Mindfulness
  • New York
  • Outcome Assessment, Health Care
  • Patient Satisfaction
  • Patient-Centered Care
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Sleep
  • Suicide /prevention & control
  • Telemedicine
Country: United States
State: District of Columbia
Zip Code: 20007
UI: 20184259
CTgovId: NCT03522844
Project Status: Ongoing