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

NCT ID: NCT05137769

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2023-02-01

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.

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.

Conditions

Post Traumatic Stress Disorder; Trauma, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Body Scan

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

Group Type: EXPERIMENTAL

Body Scan

Intervention Type: BEHAVIORAL

The body scan is a core element of mindfulness-based stress reduction. Participants will listen to a 20-minute audio guide instructing them to focus on sensations in the body, place attention on one area of the body at a time, and progressively move attention throughout areas of the body.

Interventions

Body Scan

The body scan is a core element of mindfulness-based stress reduction. Participants will listen to a 20-minute audio guide instructing them to focus on sensations in the body, place attention on one area of the body at a time, and progressively move attention throughout areas of the body.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Previously experienced a traumatic event as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) >6 months prior,

2. self-identify as a woman and were assigned female sex at birth,

3. >18 years of age,

4. fluency in English,

5. access to computer or smartphone to complete REDCap surveys and videoconference study visit.

Exclusion Criteria

1. active suicidal thoughts with a plan,

2. unable to abstain from drugs or alcohol for >48 hours prior to study videoconference,

3. current or history of psychosis with auditory and/or visual hallucinations,

4. meditated or practiced yoga >1 time(s) per month over past 6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Hannah G. Nolte

PhD Candidate, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannah G Nolte, PhD(C)

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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

Countries

United States

Other Identifiers

211345

Identifier Type: -

Identifier Source: org_study_id