Mindful Self-compassion for Anxiety and Depression: Impact of Delivery Method

Official title

Mindful Self-Compassion for Anxiety and Depression: A Randomized Comparison of In-Person Versus Videoconference Delivery

Overview

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.

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 in-person 8-week class called Mindful Self-Compassion training or a video-conference 8-week class called Mindful Self-Compassion.

Interventions

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

Primary outcome measures

• Self-Critical Rumination Scale (SCRS) [Time frame: 8 weeks]
• Hospital Anxiety and Disease Scale (HADS) [Time frame: 8 weeks]

Secondary outcome measures (9)

• PROMIS Depression Short Form [Time frame: 8 weeks]
• Difficulties in Emotion Regulation Scale-Short Form [Time frame: 8 weeks]
• Penn State Worry Questionnaire (PSWQ) [Time frame: 8 weeks]
• PROMIS Anxiety Short Form [Time frame: 8 weeks]
• PROMIS Sleep-Anxiety measure [Time frame: 8 weeks]
• Liebowitz Social Anxiety Scale (LSAS) [Time frame: 8 weeks]
• Self-Compassion Scale (SCS) [Time frame: 8 weeks]
• Fear of Compassion [Time frame: 8 weeks]
• Guilt and Shame Questionnaire (GSQ) [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Georgetown University Medical Center — Washington D.C.

Identifiers

NCT: NCT07028216 · 00005863-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗