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Mindful Self-Compassion for Anxiety Disorders and Depression

Primary Purpose

Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Self-Compassion
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindful Self-Compassion

Treatment as Usual (TAU)

Arm Description

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.

The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers.

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale

Secondary Outcome Measures

Self-compassion Scale
Self-Report questionnaire of 26 items on 5 point likert scale

Full Information

First Posted
December 31, 2022
Last Updated
June 16, 2023
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT05671419
Brief Title
Mindful Self-Compassion for Anxiety Disorders and Depression
Official Title
Mindful Self-Compassion for Anxiety Disorders and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Social Phobia, Panic Disorder, Agoraphobia, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The study investigator will be masked to treatment assignment.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Self-Compassion
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Self-Compassion
Intervention Description
The course teaching mindfulness meditation skills relevant to cultivating self-compassion.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
Self-report questionnaire of anxiety and depression symptoms, 14 items using 4-point likert scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Self-compassion Scale
Description
Self-Report questionnaire of 26 items on 5 point likert scale
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charisma, Study Coordinator
Phone
202-687-7283
Email
anxietyresearch@georgetown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoge, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoge
Phone
202-687-7283
Email
eah103@georgetown.edu

12. IPD Sharing Statement

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Mindful Self-Compassion for Anxiety Disorders and Depression

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