CompletedNCT03206437Updated Dec 23, 2022

Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

An interventional study of Mindfulness-Based Stress Reduction and Waitlist in Anxiety Disorders, Generalized Anxiety Disorder and Social Anxiety Disorder, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by Georgetown University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

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

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Keywords

mindfulness
meditation

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Investigator, Outcomes assessor)
Enrollment: 45 participants (actual)

Study arms

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
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

Interventions

BehavioralMindfulness-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.
BehavioralWaitlist
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 researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

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

References and documents

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. PubMed 22362158 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03206437
Lead sponsor: Georgetown University
Responsible party: Sponsor
First posted: Jul 2, 2017
Start date: Jun 20, 2017
Primary completion: Nov 25, 2022
Completion: Nov 25, 2022
Last update: Dec 23, 2022

Study contacts

Elizabeth A Hoge

principal investigator · Georgetown University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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