Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Generalized Anxiety Disorder; Post Traumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Simple Phobia
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Waitlist

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction; 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; 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.
Other: Waitlist; 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; 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.

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

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Elizabeth A Hoge, Georgetown University

Publications and helpful links

General Publications

• Schmitz A, Grillon C. Assessing fear and anxiety in humans using the threat of predictable and unpredictable aversive events (the NPU-threat test). Nat Protoc. 2012 Feb 23;7(3):527-32. doi: 10.1038/nprot.2012.001.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): November 25, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: mindfulness; meditation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Phobic Disorders; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: 2017-0698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No