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NCT05137769 | Completed | Post Traumatic Stress Disorder


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

Vanderbilt University

Information provided by (Responsible Party):

Hannah G. Nolte

Brief Summary:

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.

Condition or disease

Post Traumatic Stress Disorder

Trauma, Psychological

Intervention/treatment

Body Scan

Phase

Not Applicable

Detailed Description:

The proposed single-group study will use a pre-post design to assess participants' responses to one exposure to a mindfulness-based body scan in a sample of women with a history of trauma and varying levels of PTSD symptoms. Quantitative measures will assess self-reported state positive affect, negative affect, and anxiety before and after the body scan, and psychosocial characteristics expected to influence responses. Individual semi-structured interviews will be conducted with a subsample of women to learn about their subjective experiences related to the body scan.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023
Arm Intervention/treatment

Experimental: Body Scan

Participants will listen to a 20-minute, audio-guided mindfulness-based body scan exercise.

Behavioral: Body Scan

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

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

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

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Locations


Not yet recruiting

United States, Tennessee

Center of Hope

Columbia, Tennessee, United States, 38402

Not yet recruiting

United States, Tennessee

Ascension Medical Group St Thomas Nashville

Nashville, Tennessee, United States, 37203

Not yet recruiting

United States, Tennessee

Sterling Primary Care Associates - Centennial

Nashville, Tennessee, United States, 37203

Not yet recruiting

United States, Tennessee

Empowered Heart

Nashville, Tennessee, United States, 37204

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