Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli

NCT03206437 | Completed

• 1 other identifier: 2017-0698
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mindfulness; meditation

Outcome Measures

Primary Outcomes (1)

• Fear and anxiety potentiated startle

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

  16 weeks

Secondary Outcomes (3)

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

  16 weeks

• The State-Trait Anxiety Inventory (STAI)

  16 weeks

• Delay Discounting

  16 weeks

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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

Waitlist

OTHER

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

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Mindfulness-Based Stress Reduction

Waitlist BEHAVIORAL

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.

Waitlist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Related 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.

  PMID: 22362158 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social; Panic Disorder; Stress Disorders, Post-Traumatic; Agoraphobia; Phobia, Specific

Interventions

Mindfulness-Based Stress Reduction; Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Elizabeth A Hoge

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since this study is focusing on a mind-body skill as a treatment it will be impossible to mask the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: June 20, 2017
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)