Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of Mindfulness-Based Stress Reduction (MBSR) on physiological reactivity. This study will focus on individuals with anxiety who will participate in an 8-week MBSR class. The investigators will test participants' reactivity to both predictable and unpredictable stimuli before and after the class to understand the physiological changes that may occur after to the intervention. Secondary measures include psychometric instruments and a delay discounting task.

Detailed Description
-----------------
Mindfulness-Based Stress Reduction (MBSR) is a manualized, systematic training in mindfulness meditation that has been found to have beneficial health effects, such as decreased stress and anxiety. The current protocol aims to examine the effects of MBSR on several physiological and behavioral measures in people with anxiety disorders, which may help us understand the effects of the intervention on anxiety. The investigators will use the NPU task as developed by the NIH, which measures an individual's response to threatening stimuli (mild shock) paired with non-threatening stimuli (geometric shapes). Individuals with anxiety disorders will be recruited to participate in this study, and will be randomized to a control (waitlist) or MBSR intervention group. Other secondary measures will examine the effects of mindfulness meditation on decision-making, and stress and anxiety symptoms.

Official Title
-----------------
Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Conditions
-----------------
Panic Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Post Traumatic Stress Disorder, Agoraphobia, Simple Phobia

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Waitlist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women from 18-65 years of age. Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, posttraumatic stress disorder (PTSD), agoraphobia, or simple phobia. Must understand study procedure and willing to participate in 2 testing visits, and MBSR course as assigned. Participants must be able to give informed consent to the study procedures. Exclusion Criteria: Subjects experiencing a current depressive episode or other axis I psychiatric disorders such as psychotic disorders, obsessive compulsive disorder, current eating disorders, bipolar disorder, and current substance use disorders. Lack of measurable eye blink/eye twitch response (3 times the baseline eye blink muscle activity as measured by electromyography) for at least 5 of 9 startles used during the habituation visit. A serious medical condition that may result in surgery or hospitalization. Subjects who will be non-compliant with the study procedures. This may include planned travel out of town. Women who are pregnant. Current evidence of median nerve entrapment or carpal tunnel syndrome. Subject who has resting blood pressure outside of a systolic blood pressure range of 90-140 mmHg, or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements, taken up to 10 minutes apart. Subjects taking benzodiazepines, barbiturates, antidepressants, antipsychotics, or sedative medications Subjects currently receiving concomitant psychotherapy directed at treating anxiety symptoms (i.e. CBT). Individuals with implanted electronic devices, such as a cardiac pacemaker. Individuals who have completed a full course of MBSR, an equivalent meditation training, or have a daily meditation practice.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>This group will take the 8 week MBSR course within 4 weeks of their first testing visit. When the course is finished they will come in for their second testing visit. The course meets once a week in person for 2.5 hours and participants are expected to do practices at home. | Behavioral: Mindfulness-Based Stress Reduction<br>* The MBSR course teaches mindfulness meditation skills. This 8-week course meets in person once a week for 2.5 hours. Participants are expected to complete practice assignments at home.<br>|
| Other: Waitlist<br>The wait-list group will not participate in the MBSR course within 4 weeks of their first testing visit. They will wait 8-16 weeks and come on for a second testing visit. After their data is collected they will be offered an MBSR course to take. | Behavioral: Waitlist<br>* This group will wait 8-16 weeks after their first testing visit and after their second study visit is completed they will be able to participate in an 8-week MBSR course.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear and anxiety potentiated startle | This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies Depression Scale (CES-D), | measures depression symptoms | 16 weeks | 
| The State-Trait Anxiety Inventory (STAI) | This is a measure of state and trait anxiety | 16 weeks | 
| Delay Discounting | This is a computer task that measures a decline in reward value over a given time | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, meditation