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Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Primary Purpose

Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness-Based Stress Reduction

Waitlist

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring mindfulness, meditation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Georgetown University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mindfulness-Based Stress Reduction

Waitlist

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fear and anxiety potentiated startle

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),

measures depression symptoms

The State-Trait Anxiety Inventory (STAI)

This is a measure of state and trait anxiety

Delay Discounting

This is a computer task that measures a decline in reward value over a given time

Full Information

NCT ID

NCT03206437

First Posted

June 28, 2017

Last Updated

December 22, 2022

Sponsor

Georgetown University

1. Study Identification

Unique Protocol Identification Number

NCT03206437

Brief Title

Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Official Title

Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

November 25, 2022 (Actual)

Study Completion Date

November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

mindfulness, meditation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-Based Stress Reduction

Arm Type

Experimental

Arm Description

Arm Title

Waitlist

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-Based Stress Reduction

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Waitlist

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fear and anxiety potentiated startle

Description

This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Center for Epidemiologic Studies Depression Scale (CES-D),

Description

measures depression symptoms

Time Frame

16 weeks

Title

The State-Trait Anxiety Inventory (STAI)

Description

This is a measure of state and trait anxiety

Time Frame

16 weeks

Title

Delay Discounting

Description

This is a computer task that measures a decline in reward value over a given time

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth A Hoge

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22362158

Citation

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.

Results Reference

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Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

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