Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Georgetown University

Status: Completed

Conditions: Post Traumatic Stress Disorder; Panic Disorder; Generalized Anxiety Disorder; Agoraphobia; Social Anxiety Disorder; Anxiety Disorders; Simple Phobia

Treatments: Behavioral: Waitlist; Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03206437

2017-0698

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women from 18-65 years of age.
2. Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, posttraumatic stress disorder (PTSD), agoraphobia, or simple phobia.
3. Must understand study procedure and willing to participate in 2 testing visits, and MBSR course as assigned.
4. Participants must be able to give informed consent to the study procedures.

Exclusion criteria

1. 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.
2. 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.
3. A serious medical condition that may result in surgery or hospitalization.
4. Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
5. Women who are pregnant.
6. Current evidence of median nerve entrapment or carpal tunnel syndrome.
7. 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.
8. Subjects taking benzodiazepines, barbiturates, antidepressants, antipsychotics, or sedative medications
9. Subjects currently receiving concomitant psychotherapy directed at treating anxiety symptoms (i.e. CBT).
10. Individuals with implanted electronic devices, such as a cardiac pacemaker.
11. Individuals who have completed a full course of MBSR, an equivalent meditation training, or have a daily meditation practice.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Waitlist

Other group

Description:

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.

Treatment:

Behavioral: Waitlist