Clinical trial NCT05137769: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Trauma, Psychological
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Positive Affect
timeFrame: Baseline to 1-minute post body scan
measure: Change in Negative Affect
timeFrame: Baseline to 1-minute post body scan
measure: Change in State Anxiety
timeFrame: Baseline to 1-minute post body scan
measure: Participant Experience (qualitative)
timeFrame: 2 weeks post the in-person study visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Center of Hope
state: Tennessee
city: Nashville
country: United States
facility: Ascension Medical Group St Thomas Nashville
state: Tennessee
city: Nashville
country: United States
facility: Sterling Primary Care Associates - Centennial
state: Tennessee
city: Nashville
country: United States
facility: Empowered Heart
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Hannah G Nolte, PhD(C)
role: PRINCIPAL_INVESTIGATOR
References: