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

NCT05137769 | Completed

• 1 other identifier: 211345
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Post Traumatic Stress Disorder; Trauma, Psychological

Outcome Measures

Primary Outcomes (4)

• Change in Positive Affect

  Positive affect will be measured with The Positive and Negative Affect Schedule-Short Form (PANAS-SF), a 20-item questionnaire with 10 items assessing positive affect and 10 items assessing negative affect. Participants will be asked to "indicate to what extent you feel this way right now, that is, at the present moment" on a five-point scale; 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The positive affect score is obtained by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19. The range of the possible total score is 10-50 with higher scores indicating greater positive affect.

  Baseline to 1-minute post body scan

• Change in Negative Affect

  Negative affect will be measured with The Positive and Negative Affect Schedule-Short Form (PANAS-SF), a 20-item questionnaire with 10 items assessing positive affect and 10 items assessing negative affect. Participants will be asked to "indicate to what extent you feel this way right now, that is, at the present moment" on a five-point scale; 1 = very slightly or not at all, 2 = a little, 3 = moderately, 4 = quite a bit and 5 = extremely. The negative affect score is obtained by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The range of the possible scores is 10-50 with higher scores indicating greater negative affect.

  Baseline to 1-minute post body scan

• Change in State Anxiety

  State anxiety will be measured with The State-Trait Anxiety Inventory-State Form (STAI-S), a 20-item questionnaire with equal numbers of anxiety-present (e.g., "I feel tense") and anxiety-absent descriptors (e.g., "I feel calm"). Participants will be asked to indicate " how you feel right now, that is, at this moment" on a four-point scale; 1= not at all, 2 = somewhat, 3 = moderately so, 4= very much so. The anxiety-absent items (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) will be reverse scored, and then all 20-items will be summed to obtain the state anxiety score. The range of the possible scores is 20-80; higher scores indicate greater state anxiety.

  Baseline to 1-minute post body scan

• Participant Experience (qualitative)

  A subset of the sample (n=20) will complete a one-on-one telephone semi-structured interview to understand participant's perceived experience of the body scan exercise.

  2 weeks post the in-person study visit.

Study Arms (1)

Body Scan

EXPERIMENTAL

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

Behavioral: Body Scan

Interventions

Body Scan 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.

Body Scan

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as a woman and were assigned female sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (4)

Center of Hope

Columbia, Tennessee, 38402, United States

Location

Ascension Medical Group St Thomas Nashville

Nashville, Tennessee, 37203, United States

Location

Sterling Primary Care Associates - Centennial

Nashville, Tennessee, 37203, United States

Location

Empowered Heart

Nashville, Tennessee, 37204, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hannah G Nolte, PhD(C)

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 30, 2021
• Study Start: April 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)