Researchers for this study use the growing and popular approach to managing anxiety for the patients: MBSR. Mindful-Based Stress Reduction, or MBSR, is the practice of calm, mindful meditation to ease stress, anxiety, and overall help people through their days. Since this study focuses on patients with anxiety, the clinical trial researchers also combine MBSR with escitalopram, an antidepressant that is widely used to treat anxiety.
This is an interventional, single-masking, randomized, parallel assignment. The primary purpose of the study is treatment. The study began on June 18, 2018 and is estimated to be completed by May 14, 2021. There is an estimated 370 participants.
- Men and women between 18 and 75 years old.
- Have an anxiety disorder including social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia
- Must understand the study’s procedures and be willing to participate in all testing visits and assigned treatments
- Participants must be able to give their informed consent to participate in the study
- Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, post-traumatic stress disorder, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders
- Current (past 6 months) substance use disorders
- A serious medical condition that may result in surgery or hospitalization
- A history of head trauma causing loss of consciousness, or ongoing cognitive decline
- Inability to understand study procedures or informed consent process, or significant personality dysfunction that has a high probability of interfering with study participation (assessed during the clinical interview)
- Subjects who will not be compliant with the study procedures
- Pregnancy, shown through a urine test at screening. Not trying to get pregnant is also necessary to be included
- Subjects taking barbiturates, SSRIs, anti-depressants, or antipsychotics. Sleep medications (other than anti-depressants) and benzodiazepines will be allowed, if they have been taken at a stable dose 4 weeks prior to the start of the study. Also, if the patient plans to continue the same dose throughout the trial. Trazadone (for sleep) above 100mg will not be allowed
- Concurrent psychotherapy that has been started within 1 month of screen interview, or ongoing psychotherapy, no matter how long ago, directed specifically toward the treatment of anxiety (such as cognitive behavioral therapy).
- Individuals who have completed a course of Meditation-Based Stress Relief (MBSR), other meditation training in the last year, or have a daily meditation practice
- Individuals reporting suicidal thoughts or suicidal behaviors within the past year
- Individuals with a medical condition (i.e., epilepsy) that may be intensified by study treatment
You may participate in this study at three locations:
- Georgetown University Medical Center in Washington, District of Columbia, U.S., 20007
- Massachusetts General Hospital in Boston, Massachusetts, U.S. 02114
- New York University in New York, New York, U.S. 10016
If you have any questions or concerns, feel free to contact Elizabeth A Hoge, MD at 202-687-0635 or at firstname.lastname@example.org. You may also contact Samantha R Philip, BS at 202-687-7283 or at email@example.com.
This clinical trial is sponsored by Georgetown University and Patient-Centered Outcomes Research Institute.
Clinical TrialsView All
Text Message Engagement Support of Mindfulness Smartphone Apps
The goal of this clinical trial is to determine the usefulness of two smartphone apps on mindfulness. The study…
Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Emergency medicine known for the mental health issues that stem from it. Employees in the emergency department (ED)…
Teenage Health and Wellness Study
This clinical trial examines how mindfulness can affect physiological stress and traumatic stress in urban…
Preventing Internalizing in Preadolescents Exposed to Chronic Stress
Since factors that bring on stress begin in early childhood, this clinical trial attempts to tackle the issue…
Mindfulness-Music Intervention for Adolescents and Young Adults With Cancer
This clinical trial aims to show how music therapy can help reduce or eliminate anxiety for teenagers and young…
Stress, Anxiety, and Mood Group Therapy
This clinical trial is being conducted for the purpose of teaching coping skills to those who suffer from stress,…
Reducing Anxiety and Stress in Primary Care Patients
This study examines if brief anxiety treatment for veterans is more effective at providing relief than usual care.…