Clinical trial NCT03484390: Effects of Mindfulness on PTSD
Official title: Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Stress Disorder, Posttraumatic
Keywords: mindfulness
posttraumatic stress disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Women
* 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.

Primary outcomes:
measure: PTSD Symptoms Checklist (PCL-5)
timeFrame: 12 weeks
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 12 weeks
measure: Heart rate variability
timeFrame: 12 weeks
measure: Useful Field of View Test (UFOV)
timeFrame: 12 weeks
measure: Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Monroe County Family Court
state: New York
Study officials:
affiliation: University of Rochester
name: Autumn Gallegos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallegos AM, Heffner KL, Cerulli C, Luck P, McGuinness S, Pigeon WR. Effects of mindfulness training on posttraumatic stress symptoms from a community-based pilot clinical trial among survivors of intimate partner violence. Psychol Trauma. 2020 Nov;12(8):859-868. doi: 10.1037/tra0000975. Epub 2020 Sep 24.