ClinicalTrials.gg
RecruitingNCT05671419Updated Jul 29, 2026

Mindful Self-Compassion for Anxiety Disorders and Depression

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 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

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

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2022, registered Dec 2022).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Social Phobia
  • Panic Disorder
  • Agoraphobia
  • Major Depressive Disorder
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 40 is below 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 75 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
40 participants (estimated)

Study arms

  • Experimental
    Mindful Self-Compassion

    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

  • No intervention
    Treatment as Usual (TAU)

    The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers.

Interventions

  • BehavioralMindful Self-Compassion

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

06

What researchers measure

Primary outcomes

  1. Hospital Anxiety and Depression Scale

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

    Time frame: 8 weeks

Secondary outcomes

  1. Self-compassion Scale

    Self-Report questionnaire of 26 items on 5 point likert scale

    Time frame: 8 weeks

  2. Liebowitz Social Anxiety Scale - Self-Report

    Measures severity of social anxiety

    Time frame: 8 weeks

  3. PROMIS-Anxiety-Short form

    measures anxiety symptoms using HealthMeasures system

    Time frame: 8 weeks

  4. PROMIS-Depression-Short Form

    measures depression symptoms using HealthMeasures system

    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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05671419
Responsible party
Elizabeth Hoge (Professor of Psychiatry, Georgetown University) — Principal investigator
First posted
Jan 4, 2023
Start date
Jan 16, 2022
Primary completion
Oct 2, 2025
Completion
Jul 2026 (estimated)
Last update
Jul 29, 2026

Study contacts

Charisma, 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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