NCT05137769

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

Completed NA Last updated 3 February 2023

What this trial tests

NA trial testing Body Scan in Post Traumatic Stress Disorder in 60 participants. Completed in 1 February 2023.

Timeline

15 April 2022

Primary endpoint
1 February 2023

1 February 2023

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	15 April 2022
Primary completion	1 February 2023
Estimated completion	1 February 2023
Sites	4 locations across United States

Drugs / interventions tested

• Body Scan

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
• Trauma, Psychological — all drugs for Trauma, Psychological →

Sponsor

Vanderbilt University

Who can join

18 and older, female only, with Post Traumatic Stress Disorder or Trauma, Psychological. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.