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Mindful Self-Compassion for Anxiety and Depression
N/A
Recruiting
Led By Elizabeth Hoge, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will compare the effect of a Mindful Self-Compassion training program on anxiety and depression in people with anxiety or depression disorders.
Who is the study for?
This trial is for adults with anxiety disorders (like social anxiety, generalized anxiety, panic disorder, or agoraphobia) or major depression who feel they aren't very self-compassionate. Participants must understand the study and agree to all parts of it. People can't join if they've had certain mental health treatments recently, have severe medical conditions that could interfere, are pregnant, prisoners, or plan to be away during the study.Check my eligibility
What is being tested?
The trial tests an 8-week Mindful Self-Compassion program against a control group not receiving this training. It aims to see if this approach helps reduce symptoms of anxiety and depression in participants compared to those who don’t receive the intervention.See study design
What are the potential side effects?
Mindful Self-Compassion is generally considered safe but may bring up uncomfortable emotions temporarily as individuals learn to cope with their feelings more compassionately.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Anxiety and Depression Scale
Secondary outcome measures
Self-compassion Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful Self-CompassionExperimental Treatment1 Intervention
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.
Group II: Treatment as Usual (TAU)Active Control1 Intervention
The TAU arm will not receive the additional treatment from the study. Subjects will receive psychiatric treatment from their usual providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Self-Compassion
2020
N/A
~650
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,462 Total Patients Enrolled
4 Trials studying Depression
2,453 Patients Enrolled for Depression
Elizabeth Hoge, MDPrincipal InvestigatorGeorgetown University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had serious thoughts or actions of suicide in the last year.I can understand and agree to the study's procedures.I started psychotherapy for anxiety within the last month or am currently in such therapy.I am unable to give consent for medical procedures or treatments.I have completed a meditation course similar to MSC within the last year.I understand the study procedures and consent process and do not have significant personality issues.I have a serious health issue that might need surgery or a hospital stay.I have been diagnosed with a primary anxiety disorder or major depression.I do not have a psychiatric disorder other than anxiety or depression.I am on stable doses of certain psychiatric meds, including sleep aids or antidepressants, for 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Mindful Self-Compassion
- Group 2: Treatment as Usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05671419 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial limited to those aged 60 or below?
"The minimum age of eligibility for this clinical trial is 18 years, while the maximum permissible age is 75."
Answered by AI
Are there currently any opportunities to participate in this clinical trial?
"Affirmative. Data available on clinicaltrials.gov indicates that this research is still open for enrolment of patients, having been first posted on January 16th 2022 and last updated December 31st 2022. 40 participants are required at one medical institution."
Answered by AI
To what extent can potential participants be eligible to join this experiment?
"This experiment is enrolling forty adults between the ages of eighteen and seventy-five who suffer from an anxiety disorder. The participants must have a primary diagnosis, score low on self-compassion tests, understand the trial's procedures and be willing to participate in all testing visits and treatments assigned, as well as provide informed consent for study participation."
Answered by AI
What is the current enrollment quota for this clinical trial?
"Confirmed. According to the clinicaltrials.gov platform, this medical survey is actively seeking patients since it was posted on January 16th 2022 and updated on December 31st 2022. A total of 40 participants are needed for 1 specific location."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Florida
Virginia
What site did they apply to?
Georgetown University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I've had anxiety since I was 19 and have had growing negative thoughts about since then. These have become much worse recently. I am wanting to try and change this. I have worked on and off with counselors and psychiatrists over the years without much success. Just looking at other possible options to help.
PatientReceived no prior treatments
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