Mindful Self-Compassion for Anxiety Disorders and Depression

Major Depressive Disorder Clinical Trial

Official title:

Mindful Self-Compassion for Anxiety Disorders and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671419
• Other study ID #: 0005683
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2022
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: Georgetown University
• Contact: Charisma, Study Coordinator
• Phone: 202-687-7283
• Email: anxietyresearch[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Mindful Self-Compassion
The course teaching mindfulness meditation skills relevant to cultivating self-compassion.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale	Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale	8 weeks
Secondary	Self-compassion Scale	Self-Report questionnaire of 26 items on 5 point likert scale	8 weeks