Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Sponsor

Georgetown University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03206437

Collaborator

(none)

Enrollment

Location

Arms

49.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Post Traumatic Stress Disorder Agoraphobia Simple Phobia	Behavioral: Mindfulness-Based Stress Reduction Behavioral: Waitlist	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Since this study is focusing on a mind-body skill as a treatment it will be impossible to mask the participant.

Primary Purpose:

Treatment

Official Title:

Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Actual Study Start Date :

Jun 20, 2017

Anticipated Primary Completion Date :

Jul 25, 2020

Anticipated Study Completion Date :

Jul 25, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Fear and anxiety potentiated startle [16 weeks]
This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.