Mindful Self-Compassion delivered in person versus by video for anxiety and depression

Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery

This project will see if an 8-week Mindful Self-Compassion class delivered in person or by video helps people with anxiety or depression have fewer symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Georgetown University (Academic / other)
• Locations: 1 site (Washington D.C., District of Columbia)
• Trial ID: NCT07028216 on ClinicalTrials.gov

What this trial studies

At Georgetown University adults with a primary anxiety disorder or current major depressive disorder who score low on self-compassion are randomized to an 8-week Mindful Self-Compassion class delivered either in person or by live video-conference. The intervention teaches mindfulness and self-compassion skills in weekly sessions and outcomes include changes in anxiety and depression symptom severity and self-compassion scores measured before and after the program. The trial compares the two delivery methods to determine whether remote delivery is as effective and acceptable as in-person classes. Study visits and standardized symptom/self-compassion measures are used to track changes over time.

Who should consider this trial

Good fit: Ideal candidates are adults with a primary diagnosis of social anxiety disorder, generalized anxiety disorder, panic disorder (including agoraphobia), or current major depressive disorder who score low on a self-compassion measure and can attend weekly sessions and study visits.

Not a fit: Patients with comorbid psychotic disorder, bipolar disorder, current post-traumatic stress disorder, recent substance use disorder, serious medical or cognitive impairment, or those who do not have low self-compassion are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this program could provide a more accessible way for people with anxiety or depression to reduce symptoms and increase self-compassion.

How similar studies have performed: Previous mindfulness-based interventions have improved self-compassion and reduced anxiety and depression in multiple studies, and early trials of remote delivery have shown promising but mixed results.

Eligibility criteria

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 informed consent to the study procedures

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 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

Where this trial is running

Washington D.C., District of Columbia

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (Recruiting)

Study contacts

• Principal investigator: Elizabeth Hoge, MD — Georgetown University
• Study coordinator: Charisma Study Coordinator

Conditions Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia; Major Depressive Disorder; Persistent Depressive Disorder