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

NCT07028216 | Recruiting

• 1 other identifier: 00005863-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Self-Critical Rumination Scale (SCRS)

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

  8 weeks

• Hospital Anxiety and Disease Scale (HADS)

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

  8 weeks

Secondary Outcomes (9)

• PROMIS Depression Short Form

  8 weeks

• Difficulties in Emotion Regulation Scale-Short Form

  8 weeks

• Penn State Worry Questionnaire (PSWQ)

  8 weeks

• PROMIS Anxiety Short Form

  8 weeks

• PROMIS Sleep-Anxiety measure

  8 weeks

Study Arms (2)

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.

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.

Behavioral: Mindful Self-Compassion

Interventions

Mindful Self-Compassion BEHAVIORAL

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

In-person MSC; Video-conference MSC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social; Panic Disorder; Agoraphobia; Depressive Disorder, Major; Dysthymic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Elizabeth Hoge, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charisma Study Coordinator

CONTACT

202-687-7283; anxietyresearch@georgetown.edu

Thirein Study Coordinator

CONTACT

202-687-7283; anxietyresearch@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study investigator will be masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)