Exercise and Therapeutic Learning Among Women With PTSD
NCT04113798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2020-06-19
Summary
This study aims to test whether aerobic exercise performed after fear extinction learning improves the consolidation and subsequent recall of the learned safety memories (i.e., fear extinction memories) among adult women with PTSD related to interpersonal violence exposure, and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study stages: Day 1 of Assessments, Day 2 of Fear Learning, Day 3 of Fear Extinction (and activity), and Day 4 of Recall of Fear Extinction.
Conditions
Interventions
- OTHER
-
Day 1 Assessments
Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)
- OTHER
-
Day 2 Fear Learning
Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.
- OTHER
-
Day 3 Fear Extinction
Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.
- BEHAVIORAL
-
Moderate Intensity Exercise
The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3
- BEHAVIORAL
-
Low Intensity Exercise
Control participants will maintain light-intensity activity (i.e., walking at \~50% of MHR) for the full duration of 30 minutes.
- OTHER
-
Day 4 Recall of Fear Extinction
During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur \~24 hours following Day 3, and lasts about 30 minutes.
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Josh Cisler, PhD · University of Wisconsin, Madison
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-08
- Primary Completion
- 2020-01-21
- Completion
- 2020-01-21
Countries
- United States
Study Locations
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