Mindful Self-Compassion for Anxiety Disorders and Depression
Recruiting · NCT05671419 · Interventional (participants receive a specific treatment) · Lead sponsor: Georgetown University
View the official record on ClinicalTrials.gov →Interventions studied
Mindful Self-Compassion
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States