ClinicalTrials.gg
RecruitingNCT07028216Updated May 5, 2026

Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method

An interventional study of Mindful Self-Compassion in Anxiety Disorders, Generalized Anxiety Disorder and Social Anxiety Disorder, sponsored by Georgetown University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Georgetown University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder
  • Agoraphobia
  • Major Depressive Disorder
  • Persistent Depressive Disorder (Dysthymia)
03

In context

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 to the study procedures

Exclusion criteria

Exclusion Criteria:

  • 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 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.
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    In-person MSC

    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.

    Behavioral: Mindful Self-Compassion

  • Active comparator
    Video-conference MSC

    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.

    Behavioral: Mindful Self-Compassion

Interventions

  • BehavioralMindful Self-Compassion

    The course teaching mindfulness meditation skills relevant to cultivating self-compassion.

06

What researchers measure

Primary outcomes

  1. Self-Critical Rumination Scale (SCRS)

    10-item questionnaire that measures ruminative processes related to self-critical thoughts.

    Time frame: 8 weeks

  2. Hospital Anxiety and Disease Scale (HADS)

    Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale

    Time frame: 8 weeks

Secondary outcomes

  1. PROMIS Depression Short Form

    8-item questionnaire that assesses the pure domain of depression in individuals aged 18 and older.

    Time frame: 8 weeks

  2. 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

    Time frame: 8 weeks

  3. Penn State Worry Questionnaire (PSWQ)

    A patient-report measure that is used to understand patients' anxiety, and worry.

    Time frame: 8 weeks

  4. 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).

    Time frame: 8 weeks

  5. PROMIS Sleep-Anxiety measure

    13 items from the PROMIS Sleep Disturbance battery, that relate specifically to sleep disturbance resulting from worry, anxiety, or stress.

    Time frame: 8 weeks

  6. 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.

    Time frame: 8 weeks

  7. 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.

    Time frame: 8 weeks

  8. 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.

    Time frame: 8 weeks

  9. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual-level participant data collected will not be made available to the general public due to conditions of ethical approval regarding confidentiality.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 18 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2025
First posted
Jun 19, 2025
StartActual
Jun 1, 2025
Primary completionEst.
Dec 17, 2026
CompletionEst.
Aug 31, 2027
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07028216
Responsible party
Elizabeth Hoge (Professor of Psychiatry, Georgetown University) — Principal investigator
First posted
Jun 19, 2025
Start date
Jun 1, 2025
Primary completion
Dec 17, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
May 5, 2026

Study contacts

Charisma Study Coordinator
Contact
anxietyresearch@georgetown.edu
202-687-7283
Thirein Study Coordinator
Contact
anxietyresearch@georgetown.edu
202-687-7283
Elizabeth Hoge, MD
principal investigator · Georgetown University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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