Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder (PTSD)

T

Thomas Adams

Status

Withdrawn

Conditions

PTSD

Treatments

Behavioral: Experimental
Behavioral: Active Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04417309
58938

Details and patient eligibility

About

This study aims to test whether aerobic exercise improves the consolidation and subsequent recall of the learned safety 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 sessions: Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and Exercise, and Day 4 of Recall of Emotional Learning.

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)

0 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 Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction
Treatment:
Behavioral: Experimental
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 Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction
Treatment:
Behavioral: Active Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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