RECRUITING

Mindful Self-Compassion for Anxiety Disorders and Depression

Conditions

Anxiety Disorders Generalized Anxiety Disorder Social Anxiety Disorder Social Phobia Panic Disorder Agoraphobia Major Depressive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mindful Self-Compassion for Anxiety Disorders and Depression

Quick Facts

Study Start:2022-01-16

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05671419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Charisma, Study Coordinator

CONTACT

202-687-7283

anxietyresearch@georgetown.edu

Principal Investigator

Elizabeth Hoge, MD

PRINCIPAL_INVESTIGATOR

Georgetown University

Study Locations (Sites)

Georgetown University Medical Center

Washington, District of Columbia, 20007

United States

Collaborators and Investigators

Sponsor: Georgetown University

Elizabeth Hoge, MD, PRINCIPAL_INVESTIGATOR, Georgetown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-16

Study Completion Date2026-07

Study Record Updates

Study Start Date2022-01-16

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Social Phobia
Panic Disorder
Agoraphobia
Major Depressive Disorder