Mindful Self-Compassion for Anxiety Disorders and Depression

Sponsor
Georgetown University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05671419
Collaborator
(none)
40
1
2
47.5
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Self-Compassion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
The study investigator will be masked to treatment assignment.
Primary Purpose:
Treatment
Official Title:
Mindful Self-Compassion for Anxiety Disorders and Depression
Actual Study Start Date :
Jan 16, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindful Self-Compassion

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.

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

No Intervention: No Treatment

The no treatment arm will not receive treatment.

Outcome Measures

Primary Outcome Measures

  1. Hospital Anxiety and Depression Scale [8 weeks]

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

Secondary Outcome Measures

  1. Self-compassion Scale [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 barbiturates, selective serotonin reuptake inhibitors, other anti-depressants, or antipsychotics. Sleep medications (other than anti-depressants) will be allowed, if has been taken at stable dose 4 weeks prior to baseline and the patient plans to continue at the same dose through the trial. Trazodone (for sleep) above 100 mg will be disallowed.

  • 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, or have an ongoing daily meditation practice.

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georgetown University Medical Center Washington District of Columbia United States 20007

Sponsors and Collaborators

  • Georgetown University

Investigators

  • Principal Investigator: Elizabeth Hoge, MD, Georgetown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Hoge, Associate Professor of Psychiatry, Georgetown University
ClinicalTrials.gov Identifier:
NCT05671419
Other Study ID Numbers:
  • 0005683
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023