Clinical trial NCT03206437: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Post Traumatic Stress Disorder
Agoraphobia
Simple Phobia
Keywords: mindfulness
meditation
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear and anxiety potentiated startle
timeFrame: 16 weeks
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale (CES-D),
timeFrame: 16 weeks
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 16 weeks
measure: Delay Discounting
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Elizabeth A Hoge
role: PRINCIPAL_INVESTIGATOR
References:
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.