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

Primary Purpose

Post Traumatic Stress Disorder, Trauma, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body Scan
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Center of Hope
  • Ascension Medical Group St Thomas Nashville
  • Sterling Primary Care Associates - Centennial
  • Empowered Heart

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Body Scan

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2021
Last Updated
February 1, 2023
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT05137769
Brief Title
Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study
Official Title
Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Trauma, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body Scan
Arm Type
Experimental
Arm Description
Participants will listen to a 20-minute, audio-guided mindfulness-based body scan exercise.
Intervention Type
Behavioral
Intervention Name(s)
Body Scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Positive Affect
Description
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.
Time Frame
Baseline to 1-minute post body scan
Title
Change in Negative Affect
Description
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.
Time Frame
Baseline to 1-minute post body scan
Title
Change in State Anxiety
Description
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.
Time Frame
Baseline to 1-minute post body scan
Title
Participant Experience (qualitative)
Description
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.
Time Frame
2 weeks post the in-person study visit.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identify as a woman and were assigned female sex at birth
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah G Nolte, PhD(C)
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Hope
City
Columbia
State/Province
Tennessee
ZIP/Postal Code
38402
Country
United States
Facility Name
Ascension Medical Group St Thomas Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Sterling Primary Care Associates - Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Empowered Heart
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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