Anxiety DisordersNCT05671419
Mindful Self-Compassion for Anxiety Disorders and Depression
A study testing Mindful Self-Compassion in people with Anxiety Disorders and Generalized Anxiety Disorder, run by Georgetown University at 1 site in United States.
Trial summary
The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder
- What is being tested?
- Mindful Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Must have a primary anxiety disorder (social anxiety disorder, generalized anxiety disorder, panic disorder, or agoraphobia) or major depressive disorder, current
- Must score low on self-compassion, as measured by the self-compassion scale
- Must understand study procedure and willing to participate in all testing visits, and treatment as assigned
- 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, obsessive compulsive disorder, eating disorders (i.e., anorexia and bulimia), bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders and current post-traumatic stress disorder as assessed by clinician at screening visit
- A serious medical condition that may result in surgery or hospitalization.
- A history of head trauma causing prolonged 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.
- Subjects taking some psychiatric medication such as barbiturates or antipsychotics. Sleep medications and some anti-depressants will be allowed, if the subject has been taken at stable dose 8 weeks prior to baseline and the patient plans to continue at the same dose through the trial.
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- 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 MSC or an equivalent meditation training in the last year.
- 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.
- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Elizabeth Hoge, 202-687-7283, eah103@georgetown.edu
About this study
The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.
Read the detailed description
Anxiety disorders, such as generalized anxiety disorder, social anxiety disorder, and panic disorder, and depressive disorders result in significant distress, impairment in social and occupational functioning and increased risk for suicide. While there are medication and psychotherapy treatment options, they can sometimes be difficult to access and may be ineffective for a proportion of the population. Also, many patients are reluctant to take psychiatric medication, and many prefer to avoid psychiatric care altogether due to stigma or distrust of medical care settings such as a psychiatry clinic. Mindfulness meditation training can be provided outside of a medical care setting and may be more acceptable and feasible for some patients.
One way that mindfulness meditation may provide unique benefits for anxiety and depression is through decreasing self-judgment and increasing self-compassion. Research has shown that people with anxiety disorders, for example, have lower levels of self-compassion than people without anxiety. This is consistent with theories about the development and phenomenology of anxiety disorders, which are characterized as having high levels of self-criticism. Mindfulness-based interventions have been shown to improve self-compassion and self-acceptance.
In this study, patients with anxiety disorders or depression will be randomized to either an 8-week class called Mindful Self-Compassion training or a group that does not receive treatment.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Social Phobia, Panic Disorder, Agoraphobia
- Being tested
- Mindful Self-Compassion
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Agoraphobia, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-CompassionBehavioural
The course teaching mindfulness meditation skills relevant to cultivating self-compassion.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion | Experimental | Mindful Self-Compassion (MSC) is a weekly class given for 8 weeks. The individual classes last about 2 hours each. The class is provided in a group setting. Receives: Behavioral: Mindful Self-Compassion |
| Treatment as Usual (TAU) | No intervention | The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
Measured: 8 weeks
Secondary outcomes (4)
Self-compassion Scale
Self-Report questionnaire of 26 items on 5 point likert scale
Measured: 8 weeks
Liebowitz Social Anxiety Scale - Self-Report
Measures severity of social anxiety
Measured: 8 weeks
PROMIS-Anxiety-Short form
measures anxiety symptoms using HealthMeasures system
Measured: 8 weeks
PROMIS-Depression-Short Form
measures depression symptoms using HealthMeasures system
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 posted4 Jan 2023
- Study start16 Jan 2022
- Primary completion2 Oct 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Hoge, Georgetown University
- Investigators
- Elizabeth Hoge, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671419
- Sponsor's protocol ID
- 0005683
- Status last verified
- Jul 2026
- First submitted
- 31 Dec 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level participant data collected will not be made available to the general public due to conditions of ethical approval regarding confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Self-Compassion for Anxiety Disorders and Depression
- ClinicalTrials.gov ID
- NCT05671419
- Acronym / sponsor ID
- 0005683
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Social Phobia, Panic Disorder, Agoraphobia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Jan 2023 (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.
The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.
Detailed description
Anxiety disorders, such as generalized anxiety disorder, social anxiety disorder, and panic disorder, and depressive disorders result in significant distress, impairment in social and occupational functioning and increased risk for suicide. While there are medication and psychotherapy treatment options, they can sometimes be difficult to access and may be ineffective for a proportion of the population. Also, many patients are reluctant to take psychiatric medication, and many prefer to avoid psychiatric care altogether due to stigma or distrust of medical care settings such as a psychiatry clinic. Mindfulness meditation training can be provided outside of a medical care setting and may be more acceptable and feasible for some patients.
One way that mindfulness meditation may provide unique benefits for anxiety and depression is through decreasing self-judgment and increasing self-compassion. Research has shown that people with anxiety disorders, for example, have lower levels of self-compassion than people without anxiety. This is consistent with theories about the development and phenomenology of anxiety disorders, which are characterized as having high levels of self-criticism. Mindfulness-based interventions have been shown to improve self-compassion and self-acceptance.
In this study, patients with anxiety disorders or depression will be randomized to either an 8-week class called Mindful Self-Compassion training or a group that does not receive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion | Experimental | Behavioral: Mindful Self-CompassionMindful Self-Compassion (MSC) is a weekly class given for 8 weeks. The individual classes last about 2 hours each. The class is provided in a group setting. |
| Treatment as Usual (TAU) | No intervention | –The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have a primary anxiety disorder (social anxiety disorder, generalized anxiety disorder, panic disorder, or agoraphobia) or major depressive disorder, current
- Must score low on self-compassion, as measured by the self-compassion scale
- Must understand study procedure and willing to participate in all testing visits, and treatment as assigned
- must be able to give informed consent to the study procedures
Key exclusion criteria (13 listed)
- Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, obsessive compulsive disorder, eating disorders (i.e., anorexia and bulimia), bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders and current post-traumatic stress disorder as assessed by clinician at screening visit
- A serious medical condition that may result in surgery or hospitalization.
- A history of head trauma causing prolonged 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 |
|---|---|---|
| Mindful Self-CompassionThe course teaching mindfulness meditation skills relevant to cultivating self-compassion. | Behavioural | Mindful Self-Compassion |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 8 weeks
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
4 secondary outcomes
Self-compassion Scale
Time frame: 8 weeks
Liebowitz Social Anxiety Scale - Self-Report
Time frame: 8 weeks
PROMIS-Anxiety-Short form
Time frame: 8 weeks
PROMIS-Depression-Short Form
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual-level participant data collected will not be made available to the general public due to conditions of ethical approval regarding confidentiality.
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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.
Elizabeth Hoge, MD 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 Mindful Self-Compassion 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 13 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charisma, Study Coordinator (202-687-7283, anxietyresearch@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression 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?
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 29 Jul 2026.