Anxiety DisordersNCT03206437
Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli
A study testing Mindfulness-Based Stress Reduction and Waitlist in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Georgetown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder
- What is being tested?
- Mindfulness-Based Stress Reduction and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
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
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post Traumatic Stress Disorder, Agoraphobia
- Being tested
- Mindfulness-Based Stress Reduction, Waitlist
- Keywords
- mindfulness, meditation
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Stress Disorders, Post-Traumatic, Agoraphobia, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
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.
WaitlistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear and anxiety potentiated startle
This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test
Measured: 16 weeks
Secondary outcomes (3)
Center for Epidemiologic Studies Depression Scale (CES-D),
measures depression symptoms
Measured: 16 weeks
The State-Trait Anxiety Inventory (STAI)
This is a measure of state and trait anxiety
Measured: 16 weeks
Delay Discounting
This is a computer task that measures a decline in reward value over a given time
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start20 Jun 2017
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Hoge, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206437
- Sponsor's protocol ID
- 2017-0698
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2017
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness Meditation on Physiological Response to Unpredictable Stimuli
- ClinicalTrials.gov ID
- NCT03206437
- Acronym / sponsor ID
- 2017-0698
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post Traumatic Stress Disorder, Agoraphobia
- Keywords
- mindfulness, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress ReductionThis 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. |
| Waitlist | Other | Behavioral: WaitlistThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionThe 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. | Behavioural | Mindfulness-Based Stress Reduction |
| WaitlistThis 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. | Behavioural | Waitlist |
Primary outcome
Fear and anxiety potentiated startle
Time frame: 16 weeks
This variable will be measured by using the Neutral, Predictable, and Unpredictable (NPU) Threat Test
3 secondary outcomes
Center for Epidemiologic Studies Depression Scale (CES-D),
Time frame: 16 weeks
The State-Trait Anxiety Inventory (STAI)
Time frame: 16 weeks
Delay Discounting
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Results publication: PubMed 22362158Schmitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Hoge principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction and Waitlist in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear and anxiety potentiated startle (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03206437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.