Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- PTSD Symptoms Checklist (PCL-5)
Study Overview
Brief Summary
The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to intimate partner violence.
Detailed Description
Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence suggests it targets these domains. The central hypothesis is that MBSR, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We will examine changes in stress capacity and PTSD symptom severity among women survivors of intimate partner violence with PTSD after participation in an MBSR program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking
- •18-64 years of age
- •Victim of IPV
- •Meet diagnostic criteria for PTSD
- •No or stable use of medications (including, for example, beta blockers).
Exclusion Criteria
- •There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score < 24) or inability to provide informed consent
- •They have ever been a perpetrator of IPV
- •History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
- •Active substance dependence or in remission < 3 months
- •Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
- •The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.
Arms & Interventions
Mindfulness-based stress reduction
The MBSR program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks.
Intervention: Mindfulness-based stress reduction (Behavioral)
Wellness Group
The Wellness control group uses a health education manual that provides information on various aspects of health, including diet, physical activity, sleep, stress management, and communication. The manual is used during weekly check-in phone calls for an 8-week period.
Intervention: Wellness Group (Behavioral)
Outcomes
Primary Outcomes
PTSD Symptoms Checklist (PCL-5)
Time Frame: 12 weeks
The PTSD Symptoms Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 asks respondents to rate how much they have been bothered by particular PTSD symptoms in the past month on a 0-4 scale.
Secondary Outcomes
- Difficulties in Emotion Regulation Scale (DERS)(12 weeks)
- Heart rate variability(12 weeks)
- Useful Field of View Test (UFOV)(12 weeks)
- Five-Facet Mindfulness Questionnaire (FFMQ)(12 weeks)
Investigators
Autumn Gallegos
Assistant Professor
University of Rochester