Anxiety DisordersNCT07028216
Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method
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 the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, 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 or… 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?
- Mindful Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Aug 2027
- 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 65 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, MD, 202-687-7283, eah103@georgetown.edu
About this study
Official title: Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery
The study will compare the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, 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 or dysthymia.
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 in-person 8-week class called Mindful Self-Compassion training or a video-conference 8-week class called Mindful Self-Compassion.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Major Depressive Disorder
- Being tested
- Mindful Self-Compassion
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Agoraphobia, Depressive Disorder, Major, Dysthymic Disorder
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 |
|---|---|---|
| In-person MSC | 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 |
| Video-conference MSC | Active comparator | 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 video-conference group setting. Receives: Behavioral: Mindful Self-Compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Critical Rumination Scale (SCRS)
10-item questionnaire that measures ruminative processes related to self-critical thoughts.
Measured: 8 weeks
Hospital Anxiety and Disease Scale (HADS)
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
Measured: 8 weeks
Secondary outcomes (9)
PROMIS Depression Short Form
8-item questionnaire that assesses the pure domain of depression in individuals aged 18 and older.
Measured: 8 weeks
Difficulties in Emotion Regulation Scale-Short Form
18-item self-report measure that has established validity and is widely used for assessing emotion regulation style in adults
Measured: 8 weeks
Penn State Worry Questionnaire (PSWQ)
A patient-report measure that is used to understand patients' anxiety, and worry.
Measured: 8 weeks
PROMIS Anxiety Short Form
8 items to assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
Measured: 8 weeks
PROMIS Sleep-Anxiety measure
13 items from the PROMIS Sleep Disturbance battery, that relate specifically to sleep disturbance resulting from worry, anxiety, or stress.
Measured: 8 weeks
Liebowitz Social Anxiety Scale (LSAS)
A questionnaire widely used to measure social anxiety through situation-based questions that also distinguishes between fear and avoidance ratings.
Measured: 8 weeks
Self-Compassion Scale (SCS)
26-item self-report instrument that uses a 5-point Likert scale for each item to assess compassion and kindness towards oneself, partially through seeing one's experiences as not unique and specific to the individual, but part of a larger human experience.
Measured: 8 weeks
Fear of Compassion
A questionnaire that is the sum of three subscales designed to assess individuals: Compassion for the self-comprised; compassion from others comprised; and compassion for others comprised. We will use the Compassion for Self subscale.
Measured: 8 weeks
Guilt and Shame Questionnaire (GSQ)
8-item survey and is currently the most reliable, valid, and quick-to-complete shame scale for use in therapy outcome studies.
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 posted19 Jun 2025
- Study start1 Jun 2025
- Primary completion17 Dec 2026 (estimated)
- Study completion31 Aug 2027 (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
- 80 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
- NCT07028216
- Sponsor's protocol ID
- 00005863-1
- Status last verified
- May 2026
- First submitted
- 11 Jun 2025
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery
- ClinicalTrials.gov ID
- NCT07028216
- Acronym / sponsor ID
- 00005863-1
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 17 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Jun 2025 (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 the delivery of an 8-week Mindful Self-Compassion training, in-person against video-conference, 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 or dysthymia.
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 in-person 8-week class called Mindful Self-Compassion training or a video-conference 8-week class called Mindful Self-Compassion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person MSC | 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. |
| Video-conference MSC | Active comparator | 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 video-conference group setting. |
Who may qualify
- Ages
- 18 to 65 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 | In-person MSC, Video-conference MSC |
Primary outcome
Self-Critical Rumination Scale (SCRS)
Time frame: 8 weeks
10-item questionnaire that measures ruminative processes related to self-critical thoughts.
Hospital Anxiety and Disease Scale (HADS)
Time frame: 8 weeks
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
9 secondary outcomes
PROMIS Depression Short Form
Time frame: 8 weeks
Difficulties in Emotion Regulation Scale-Short Form
Time frame: 8 weeks
Penn State Worry Questionnaire (PSWQ)
Time frame: 8 weeks
PROMIS Anxiety Short Form
Time frame: 8 weeks
PROMIS Sleep-Anxiety measure
Time frame: 8 weeks
Liebowitz Social Anxiety Scale (LSAS)
Time frame: 8 weeks
Self-Compassion Scale (SCS)
Time frame: 8 weeks
Fear of Compassion
Time frame: 8 weeks
Guilt and Shame Questionnaire (GSQ)
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 5 May 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 5 May 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?
Self-Critical Rumination Scale (SCRS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 5 May 2026.