Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Anxiety Disorders Clinical Trial

Official title:

Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206437
• Other study ID #: 2017-0698
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2022
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear and anxiety potentiated startle	This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test	16 weeks
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D),	measures depression symptoms	16 weeks
Secondary	The State-Trait Anxiety Inventory (STAI)	This is a measure of state and trait anxiety	16 weeks
Secondary	Delay Discounting	This is a computer task that measures a decline in reward value over a given time	16 weeks