Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Location status: Recruiting
NCT Number: NCT07028216
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20007, United States
Location status: Recruiting
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 in-person 8-week class called Mindful Self-Compassion training or a video-conference 8-week class called Mindful Self-Compassion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The course teaching mindfulness meditation skills relevant to cultivating self-compassion.
Time frame: 8 weeks
10-item questionnaire that measures ruminative processes related to self-critical thoughts.
Time frame: 8 weeks
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
Time frame: 8 weeks
8-item questionnaire that assesses the pure domain of depression in individuals aged 18 and older.
Time frame: 8 weeks
18-item self-report measure that has established validity and is widely used for assessing emotion regulation style in adults
Time frame: 8 weeks
A patient-report measure that is used to understand patients' anxiety, and worry.
Time frame: 8 weeks
8 items to assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).
Time frame: 8 weeks
13 items from the PROMIS Sleep Disturbance battery, that relate specifically to sleep disturbance resulting from worry, anxiety, or stress.
Time frame: 8 weeks
A questionnaire widely used to measure social anxiety through situation-based questions that also distinguishes between fear and avoidance ratings.
Time frame: 8 weeks
26-item self-report instrument that uses a 5-point Likert scale for each item to assess compassion and kindness towards oneself, partially through seeing one's experiences as not unique and specific to the individual, but part of a larger human experience.
Time frame: 8 weeks
A questionnaire that is the sum of three subscales designed to assess individuals: Compassion for the self-comprised; compassion from others comprised; and compassion for others comprised. We will use the Compassion for Self subscale.
Time frame: 8 weeks
8-item survey and is currently the most reliable, valid, and quick-to-complete shame scale for use in therapy outcome studies.
Contact information is provided by the study sponsor or research team.
Charisma Study Coordinator
CONTACT
Thirein Study Coordinator
CONTACT
Georgetown University
Other
Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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