Exercise and Therapeutic Learning Among Women With PTSD

University of Wisconsin (UW)

Status: Completed

Conditions: PTSD

Treatments: Behavioral: Low Intensity Exercise; Behavioral: Moderate Intensity Exercise; Other: Day 1 Assessments; Other: Day 3 Fear Extinction; Other: Day 2 Fear Learning; Other: Day 4 Recall of Fear Extinction

Study type: Interventional

Funder types: Other

Identifiers

NCT04113798

A538900 (Other Identifier)

2018-0845

Protocol Version 11/4/2019 (Other Identifier)

SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
• English speaking
• Medically healthy

Exclusion criteria

• Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.

• Major medical disorders (such as cancer, AIDS)

• Physical discomfort or difficulty with blood draws

• Psychotic disorders

• Intellectual disabilities

• Developmental disorders

• Active substance use disorders

• Pregnancy

• Due to safety concerns, participants with these conditions will be ineligible to participate:

  • Major medical disorders (e.g., HIV, cancer)
  • Daily cannabis use
  • History of light headedness or fainting during blood draws or physical activity
  • History of chest pain during physical activity
  • Abnormal EKG finding at intake visit screening, without follow-up clearance from their physician
  • Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD), diabetes, hypertension) that is not currently addressed via medication or lifestyle change.
  • A positive pregnancy test
  • A self-reported history of loss of consciousness (greater than 30 minutes)
  • Physical disabilities that prohibit task performance (such as blindness or deafness)
  • Psychotic disorders (e.g., schizophrenia)
  • Any other condition that the investigator believes might put the participant at risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Moderate Intensity Exercise

Experimental group

Description:

Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by moderate intensity exercise), Day 4 Recall of Fear Extinction

Treatment:

Other: Day 1 Assessments

Behavioral: Moderate Intensity Exercise

Other: Day 2 Fear Learning

Other: Day 3 Fear Extinction

Other: Day 4 Recall of Fear Extinction

Control

Active Comparator group

Description:

Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by low intensity exercise), Day 4 Recall of Fear Extinction

Treatment:

Other: Day 1 Assessments

Other: Day 2 Fear Learning

Other: Day 3 Fear Extinction

Other: Day 4 Recall of Fear Extinction

Behavioral: Low Intensity Exercise