Anxiety DisordersPhase 4TAMENCT03522844
Treatments for Anxiety: Meditation and Escitalopram
A Phase 4 study testing Mindfulness-Based Stress Reduction and Escitalopram in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Georgetown University at 3 sites in United States.
Trial summary
We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- Mindfulness-Based Stress Reduction and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jun 2018to 5 Jan 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 75 years old.
- Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia
- Must understand study procedure and be willing to participate in all testing visits and treatment as assigned.
- Participants must be able to give informed consent to the study procedures.
Who cannot join
- Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, post-traumatic stress disorder, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders.
- A serious medical condition that may result in surgery or hospitalization.
- A history of head trauma causing loss of consciousness, or ongoing cognitive impairment
- Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview).
- Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
- Pregnancy as assessed by urine test at screen. Avoidance of pregnancy is also necessary for inclusion in the study.
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- Subjects taking barbiturates, SSRIs, anti-depressants, or antipsychotics. Sleep medications (other than anti-depressants) and benzodiazepines will be allowed, if has been taken at stable dose 4 weeks prior to baseline and the patient plans to continue at the same dose through the trial. Trazadone (for sleep) above 100mg will be disallowed.
- Concurrent psychotherapy initiated within 1 month of screen interview, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety (such as cognitive behavioral therapy).
- Individuals who have completed a course of MBSR or an equivalent meditation training in the last year, or have an ongoing daily meditation practice
- Individuals reporting significant active suicidal ideation or suicidal behaviors within the past year.
- Individuals with a medical condition (i.e., epilepsy) that may be exacerbated by study treatment, as determined by a study physician or nurse practitioner based on history, physical, and/or labs.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
New York University
New York, New York, 10016
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety
We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.
Read the detailed description
Mindfulness meditation treatments have been growing in popularity and becoming widely disseminated, and people with anxiety are interested in mindfulness. A benefit of mindfulness interventions is that they can be provided outside of a mental health setting, which may make them more acceptable to patients. Although mindfulness meditation is gaining popularity, there is no information how this treatment strategy compares with standard treatment, such as with medication. Patients need more information about the comparison of treatments to be able to make informed decisions about their health care. We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to escitalopram, a standard medication for patients with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia.
Patients will be randomized into two 8-week treatments: (1) MBSR and (2) escitalopram. To enroll the necessary sample, we will utilize three study sites in different geographic locations that each have strong clinical and research infrastructures: Georgetown University Medical Center, Massachusetts General Hospital and New York University Langone Medical Center. Thus, we will take advantage of three productive teams with previous successful collaborations and experience in mind-body treatment studies.
Adaptations and Additional Aims:
Due to the COVID-19 pandemic, the study was transitioned to a virtual format (on-line videoconference visits) in March 2020 as a pilot adaptation with the introduction of additional aims to explore the following: (1) the comparative effectiveness and treatment satisfaction for in-person MBSR versus virtual MBSR and (2) the comparative effectiveness of virtual MBSR versus virtual pharmacotherapy. An additional 202 participants were randomized to the virtual version of the study to support these aims.
Note about the in-person recruitment: Due to the impact of pandemic-related and participant-related confounders, it has not been possible to return to in-person treatments since March 2020. Before the pandemic, we had published a methods paper adopting (a priori) a non-inferiority margin of 0.495 points on the CGI-S for the analysis of the primary hypothesis. Although we were not able to enroll the proposed sample size of 368 due to the pandemic, with 276 patients randomized, we have sufficient statistical power of 80% for our original analysis to stop in person enrollment.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Agoraphobia
- Being tested
- Mindfulness-Based Stress Reduction, Escitalopram
- Keywords
- mindfulness, escitalopram, anxiety
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Panic Disorder, Phobia, Social, Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionOther
Participants randomized to the MBSR intervention will consist of an 8-week Mindfulness-Based Stress Reduction (MBSR) program, taught and facilitated by a trained instructor. The classes instruct participants in the theory and practice of several forms of mindfulness meditation: a body scan, breathing awareness, and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. The intervention will include a weekly class for 8 weeks and classes will be 2.5 hours in duration. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities.
EscitalopramDrug
Escitalopram is an antidepressant, widely used to treat anxiety disorders. During the 8 weeks of randomized treatment with escitalopram, subjects will be seen regularly by a study physician. The pill medication will be initiated at 10 mg/day; at week 2, dosage will be increased to 20 mg/day if well tolerated (or delayed if not). Side effects will be assessed at each visit and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Not described Receives: Other: Mindfulness-Based Stress Reduction |
| Escitalopram | Active comparator | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Severity scale
The CGI is a measure of symptom severity and is rated by a clinician
Measured: 8 weeks
Secondary outcomes (11)
Clinical Global Impression- Improvement (CGI-I)
The CGI-I measures symptom improvement and is rated by a clinician
Measured: 8 weeks
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
The SIGH-A assesses general anxiety symptoms and is rated by a clinician
Measured: 8 weeks
Liebowitz Social Anxiety Scale (LSAS)
The LSAS measures social anxiety and is rated by a clinician
Measured: 8 weeks
Panic Disorder Severity Scale (PDSS)
The PDSS measures panic symptom severity and is rated by a clinician
Measured: 8 weeks
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a patient-reported measure is anxiety symptoms
Measured: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a patient-reported measure of sleep
Measured: 8 weeks
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a patient-reported measure of worry
Measured: 8 weeks
Beck Anxiety Inventory (BAI)
The BAI is a patient-reported measure is anxiety symptoms
Measured: 8 weeks
PROMIS-Satisfaction with Participation in Social Roles (SPSR)
The PROMIS-SPSR is a patient-reported measure of contentment with social roles
Measured: 8 weeks
PROMIS- Emotional Distress Scales (ED)
The PROMIS-ED scales are patient-reported measures of emotional distress, such as anxiety and depression
Measured: 8 weeks
PROMIS-Ability to Participate in Social Roles and Activities (APSRA)
The PROMIS-APSRA is a patient-reported measure of ability to perform usual social roles and activities
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start18 Jun 2018
- Primary completion31 Oct 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive one of two treatments over the course of 8-weeks. One group will participate in an 8-week Mindfulness-Based Stress Reduction Course and the other group will receive a daily medication treatment (escitalopram).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Elizabeth Hoge, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522844
- Sponsor's protocol ID
- 2017-1464
- Acronym
- TAME
- Status last verified
- Jan 2022
- First submitted
- 1 May 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoge EA, Mete M, Baker AW, Szuhany KL, Armstrong CH, Steinberg MH, Dutton MA, Bui E, Simon NM. A randomized controlled trial comparing mindfulness to escitalopram for anxiety: In-person and remote, synchronous delivery pre and post COVID-19 pandemic. J Affect Disord. 2025 Sep 1;384:163-172. doi: 10.1016/j.jad.2025.04.145. Epub 2025 May 3.
PubMed 40324655Hu H, Mete M, Rustgi NK, Washington CI, Sanghavi K, Dutton MA, Simon NM, Baker AW, Bui E, Hoge EA. Mindfulness Meditation vs Escitalopram for Treatment of Anxiety Disorders: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438453. doi: 10.1001/jamanetworkopen.2024.38453.
PubMed 39382900Oft AC, Philip S, Holz E, Sathi S, Geng X, Hoge E. Effect of meditation or escitalopram on work performance in patients with anxiety disorders. J Affect Disord. 2024 Nov 1;364:104-107. doi: 10.1016/j.jad.2024.08.019. Epub 2024 Aug 10.
PubMed 39134156Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jan 1;80(1):13-21. doi: 10.1001/jamapsychiatry.2022.3679.
PubMed 36350591
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety
- ClinicalTrials.gov ID
- NCT03522844
- Acronym / sponsor ID
- TAME / 2017-1464
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Agoraphobia
- Keywords
- mindfulness, escitalopram, anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 11 May 2018 (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.
We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.
Detailed description
Mindfulness meditation treatments have been growing in popularity and becoming widely disseminated, and people with anxiety are interested in mindfulness. A benefit of mindfulness interventions is that they can be provided outside of a mental health setting, which may make them more acceptable to patients. Although mindfulness meditation is gaining popularity, there is no information how this treatment strategy compares with standard treatment, such as with medication. Patients need more information about the comparison of treatments to be able to make informed decisions about their health care. We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to escitalopram, a standard medication for patients with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia.
Patients will be randomized into two 8-week treatments: (1) MBSR and (2) escitalopram. To enroll the necessary sample, we will utilize three study sites in different geographic locations that each have strong clinical and research infrastructures: Georgetown University Medical Center, Massachusetts General Hospital and New York University Langone Medical Center. Thus, we will take advantage of three productive teams with previous successful collaborations and experience in mind-body treatment studies.
Adaptations and Additional Aims:
Due to the COVID-19 pandemic, the study was transitioned to a virtual format (on-line videoconference visits) in March 2020 as a pilot adaptation with the introduction of additional aims to explore the following: (1) the comparative effectiveness and treatment satisfaction for in-person MBSR versus virtual MBSR and (2) the comparative effectiveness of virtual MBSR versus virtual pharmacotherapy. An additional 202 participants were randomized to the virtual version of the study to support these aims.
Note about the in-person recruitment: Due to the impact of pandemic-related and participant-related confounders, it has not been possible to return to in-person treatments since March 2020. Before the pandemic, we had published a methods paper adopting (a priori) a non-inferiority margin of 0.495 points on the CGI-S for the analysis of the primary hypothesis. Although we were not able to enroll the proposed sample size of 368 due to the pandemic, with 276 patients randomized, we have sufficient statistical power of 80% for our original analysis to stop in person enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive one of two treatments over the course of 8-weeks. One group will participate in an 8-week Mindfulness-Based Stress Reduction Course and the other group will receive a daily medication treatment (escitalopram).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Other: Mindfulness-Based Stress Reduction |
| Escitalopram | Active comparator | Drug: Escitalopram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 75 years old.
- Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia
- Must understand study procedure and be willing to participate in all testing visits and treatment as assigned.
- Participants must be able to give informed consent to the study procedures.
Key exclusion criteria (11 listed)
- Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, post-traumatic stress disorder, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders.
- A serious medical condition that may result in surgery or hospitalization.
- A history of head trauma causing loss of consciousness, or ongoing cognitive impairment
- Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview).
- Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
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 ReductionParticipants randomized to the MBSR intervention will consist of an 8-week Mindfulness-Based Stress Reduction (MBSR) program, taught and facilitated by a trained instructor. The classes instruct participants in the theory and practice of several forms of mindfulness meditation: a body scan, breathing awareness, and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. The intervention will include a weekly class for 8 weeks and classes will be 2.5 hours in duration. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities. | Other | Mindfulness-Based Stress Reduction (MBSR) |
| EscitalopramEscitalopram is an antidepressant, widely used to treat anxiety disorders. During the 8 weeks of randomized treatment with escitalopram, subjects will be seen regularly by a study physician. The pill medication will be initiated at 10 mg/day; at week 2, dosage will be increased to 20 mg/day if well tolerated (or delayed if not). Side effects will be assessed at each visit and recorded. | Drug | Escitalopram |
Primary outcome
Clinical Global Impression of Severity scale
Time frame: 8 weeks
The CGI is a measure of symptom severity and is rated by a clinician
11 secondary outcomes
Clinical Global Impression- Improvement (CGI-I)
Time frame: 8 weeks
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
Time frame: 8 weeks
Liebowitz Social Anxiety Scale (LSAS)
Time frame: 8 weeks
Panic Disorder Severity Scale (PDSS)
Time frame: 8 weeks
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
Penn State Worry Questionnaire (PSWQ)
Time frame: 8 weeks
Beck Anxiety Inventory (BAI)
Time frame: 8 weeks
PROMIS-Satisfaction with Participation in Social Roles (SPSR)
Time frame: 8 weeks
PROMIS- Emotional Distress Scales (ED)
Time frame: 8 weeks
PROMIS-Ability to Participate in Social Roles and Activities (APSRA)
Time frame: 8 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 11 Jan 2022.
- Derived from this study: PubMed 40324655Hoge EA, Mete M, Baker AW, Szuhany KL, Armstrong CH, Steinberg MH, Dutton MA, Bui E, Simon NM. A randomized controlled trial comparing mindfulness to escitalopram for anxiety: In-person and remote, synchronous delivery pre and post COVID-19 pandemic. J Affect Disord. 2025 Sep 1;384:163-172. doi: 10.1016/j.jad.2025.04.145. Epub 2025 May 3.
- Derived from this study: PubMed 39382900Hu H, Mete M, Rustgi NK, Washington CI, Sanghavi K, Dutton MA, Simon NM, Baker AW, Bui E, Hoge EA. Mindfulness Meditation vs Escitalopram for Treatment of Anxiety Disorders: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438453. doi: 10.1001/jamanetworkopen.2024.38453.
- Derived from this study: PubMed 39134156Oft AC, Philip S, Holz E, Sathi S, Geng X, Hoge E. Effect of meditation or escitalopram on work performance in patients with anxiety disorders. J Affect Disord. 2024 Nov 1;364:104-107. doi: 10.1016/j.jad.2024.08.019. Epub 2024 Aug 10.
- Derived from this study: PubMed 36350591Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jan 1;80(1):13-21. doi: 10.1001/jamapsychiatry.2022.3679.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mindfulness-Based Stress Reduction and Escitalopram in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Georgetown University at 3 sites 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical Global Impression of Severity scale (time frame: 8 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 NCT03522844, which also lists 4 linked publications.
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 11 Jan 2022.