Post Traumatic Stress DisorderNCT05137769
Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study
A study testing Body Scan in people with Post Traumatic Stress Disorder and Trauma, Psychological, run by Vanderbilt University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Trauma, Psychological
- What is being tested?
- Body Scan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Center of Hope
Columbia, Tennessee, 38402
Ascension Medical Group St Thomas Nashville
Nashville, Tennessee, 37203
Sterling Primary Care Associates - Centennial
Nashville, Tennessee, 37203
Empowered Heart
Nashville, Tennessee, 37204
About this study
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.
Read the 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.
- Being tested
- Body Scan
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body ScanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Scan | Experimental | Participants will listen to a 20-minute, audio-guided mindfulness-based body scan exercise. Receives: Behavioral: Body Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks post the in-person study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Apr 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah G. Nolte, Vanderbilt University
- Investigators
- Hannah G Nolte, PhD(C), Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137769
- Sponsor's protocol ID
- 211345
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Responses to a Mindfulness-Based Body Scan: A Pilot Study
- ClinicalTrials.gov ID
- NCT05137769
- Acronym / sponsor ID
- 211345
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Scan | Experimental | Behavioral: Body ScanParticipants will listen to a 20-minute, audio-guided mindfulness-based body scan exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body ScanThe 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. | Behavioural | Body Scan |
Primary outcome
Change in Positive Affect
Time frame: Baseline to 1-minute post body scan
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
Time frame: Baseline to 1-minute post body scan
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
Time frame: Baseline to 1-minute post body scan
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)
Time frame: 2 weeks post the in-person study visit.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah G Nolte, PhD(C) principal investigator
Vanderbilt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Scan in people with Post Traumatic Stress Disorder and Trauma, Psychological, run by Vanderbilt University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive Affect (time frame: Baseline to 1-minute post body scan). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.