Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study

Completed · Not applicable

Conditions studied: Post Traumatic Stress Disorder, Trauma, Psychological

In brief

PTSD develops after trauma and is marked by intrusive memories, avoidance of reminders, negative changes in mood and cognitive processes, and dysregulated physical and emotional stress reactivity. PTSD disparately affects twice as many women as men (8.0% vs. 4.1%), and finding effective treatments for these women is critical to reduce poor health outcomes associated with PTSD. Mind-body therapies (MBT), using the mind in combination with the body to facilitate healing hold promise to enhance PTSD treatment by improving stress regulation. While MBT reduce PTSD symptoms long-term, women with PTSD may initially experience distress, leading to treatment avoidance. This pilot study will explore women's initial responses to MBT, the prevalence of adverse responses, and which women are at risk for adverse responses in a sample of participants with a history of trauma and varying levels of PTSD symptoms. Study participants will attend one virtual study visit via one-on-one videoconference with the PI, where they will complete self-report measures of stress and affect before and after one session of a MBT exercise. A subset of the sample will complete a semi-structured individual videoconference interview with the PI within two weeks following completion of the MBT exercise and quantitative measures.

Key facts

Study ID

NCT05137769

Run by

Vanderbilt University

People needed

60

Starts

2022-04-15

Expected to finish

2023-02-01

Last updated by the study team

2023-02-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Previously experienced a traumatic event as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) >6 months prior,
• self-identify as a woman and were assigned female sex at birth,
• >18 years of age,
• fluency in English,
• access to computer or smartphone to complete REDCap surveys and videoconference study visit.

You may not qualify if…

• active suicidal thoughts with a plan,
• unable to abstain from drugs or alcohol for >48 hours prior to study videoconference,
• current or history of psychosis with auditory and/or visual hallucinations,
• meditated or practiced yoga >1 time(s) per month over past 6 months.

Where it is running

• Center of Hope — Columbia, Tennessee, United States
• Ascension Medical Group St Thomas Nashville — Nashville, Tennessee, United States
• Sterling Primary Care Associates - Centennial — Nashville, Tennessee, United States
• Empowered Heart — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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