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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGeorgetown University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindful Self-Compassion

    Behavioral

    The course teaching mindfulness meditation skills relevant to cultivating self-compassion.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: In-person MSCExperimental treatment 1 intervention
Group B: Video-conference MSCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-Critical Rumination Scale (SCRS)

10-item questionnaire that measures ruminative processes related to self-critical thoughts.

Time frame
8 weeks
2

Hospital Anxiety and Disease Scale (HADS)

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

Time frame
8 weeks

Secondary outcomes

1

PROMIS Depression Short Form

8-item questionnaire that assesses the pure domain of depression in individuals aged 18 and older.

Time frame
8 weeks
2

Difficulties in Emotion Regulation Scale-Short Form

18-item self-report measure that has established validity and is widely used for assessing emotion regulation style in adults

Time frame
8 weeks
3

Penn State Worry Questionnaire (PSWQ)

A patient-report measure that is used to understand patients' anxiety, and worry.

Time frame
8 weeks
4

PROMIS Anxiety Short Form

8 items to assess self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness).

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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