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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person MSC | 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. |
|
| Video-conference MSC | Active Comparator | 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 video-conference group setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Self-Compassion | Behavioral | The course teaching mindfulness meditation skills relevant to cultivating self-compassion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Critical Rumination Scale (SCRS) | 10-item questionnaire that measures ruminative processes related to self-critical thoughts. | 8 weeks |
| Hospital Anxiety and Disease Scale (HADS) | Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Depression Short Form | 8-item questionnaire that assesses the pure domain of depression in individuals aged 18 and older. | 8 weeks |
| Difficulties in Emotion Regulation Scale-Short Form | 18-item self-report measure that has established validity and is widely used for assessing emotion regulation style in adults |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charisma Study Coordinator | Contact | 202-687-7283 | anxietyresearch@georgetown.edu | |
| Thirein Study Coordinator | Contact | 202-687-7283 | anxietyresearch@georgetown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Hoge, MD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
Individual-level participant data collected will not be made available to the general public due to conditions of ethical approval regarding confidentiality.
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The study investigator will be masked to treatment assignment.
| 8 weeks |
| Penn State Worry Questionnaire (PSWQ) | A patient-report measure that is used to understand patients' anxiety, and worry. | 8 weeks |
| PROMIS Anxiety Short Form | 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). | 8 weeks |
| PROMIS Sleep-Anxiety measure | 13 items from the PROMIS Sleep Disturbance battery, that relate specifically to sleep disturbance resulting from worry, anxiety, or stress. | 8 weeks |
| Liebowitz Social Anxiety Scale (LSAS) | A questionnaire widely used to measure social anxiety through situation-based questions that also distinguishes between fear and avoidance ratings. | 8 weeks |
| Self-Compassion Scale (SCS) | 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. | 8 weeks |
| Fear of Compassion | 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. | 8 weeks |
| Guilt and Shame Questionnaire (GSQ) | 8-item survey and is currently the most reliable, valid, and quick-to-complete shame scale for use in therapy outcome studies. | 8 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| D000379 | Agoraphobia |
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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