Mindful Self-Compassion for Anxiety Disorders and Depression

NCT05671419 | Recruiting

• 1 other identifier: 0005683
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

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

  8 weeks

Secondary Outcomes (4)

• Self-compassion Scale

  8 weeks

• Liebowitz Social Anxiety Scale - Self-Report

  8 weeks

• PROMIS-Anxiety-Short form

  8 weeks

• PROMIS-Depression-Short Form

  8 weeks

Study Arms (2)

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.

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.

Interventions

Mindful Self-Compassion BEHAVIORAL

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

Mindful Self-Compassion

Eligibility Criteria

• Age: 18 Years - 75 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

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

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: December 31, 2022
• First Posted: January 4, 2023
• Study Start: January 16, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)