Clinical trial NCT04417309: Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder
Official title: Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Keywords: Women, Exercise, Mental Health
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Skin Conductance Responding (SCR)
timeFrame: up to Day 4
measure: Participant Expectancy Ratings
timeFrame: Up to day 4
measure: Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: before and after 30 min exercise on Day 3
measure: Group Differences in Serum Endocannabinoid (eCB) Content
timeFrame: before and after 30 min exercise on Day 3
Secondary outcomes:
measure: Change in Profile of Mood States (POMS) Questionnaire
timeFrame: at each visit, up to Day 4
measure: Change in State-Trait Anxiety Inventory (STAI)
timeFrame: at each visit, up to Day 4
measure: Change in Positive and Negative Affect Scale (PANAS)
timeFrame: at each visit, up to Day 4
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Thomas G Adams Jr, PhD
role: PRINCIPAL_INVESTIGATOR
References: