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Clinical Trials/NCT04417309
NCT04417309
Withdrawn
Not Applicable

Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder

Thomas Adams1 site in 1 countryMay 8, 2020
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Thomas Adams
Locations
1
Primary Endpoint
Participant Skin Conductance Responding (SCR)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2020
End Date
November 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Thomas Adams
Responsible Party
Sponsor Investigator
Principal Investigator

Thomas Adams

Assistant Professor

University of Kentucky

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)

Outcomes

Primary Outcomes

Participant Skin Conductance Responding (SCR)

Time Frame: up to Day 4

Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (skin conductance responses). SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Participants will be instructed to select an intensity of a 7/10 on the subjective pain scale, which should be "uncomfortable, but not painful." Average intensity of participant skin conductance will be reported.

Group Differences in Serum Endocannabinoid (eCB) Content

Time Frame: before and after 30 min exercise on Day 3

Aim 2 group differences in eCB consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is eCBs increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.

Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)

Time Frame: before and after 30 min exercise on Day 3

Aim 2 group differences in BDNF consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is BDNF increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.

Participant Expectancy Ratings

Time Frame: Up to day 4

Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (expectancy ratings). Expectancy will be assessed throughout each phase of the experiment to estimate the degree to which the subject believes she will receive a shock following presentation of certain pictures presented during the experiment.

Secondary Outcomes

  • Change in State-Trait Anxiety Inventory (STAI)(at each visit, up to Day 4)
  • Change in Positive and Negative Affect Scale (PANAS)(at each visit, up to Day 4)
  • Change in Profile of Mood States (POMS) Questionnaire(at each visit, up to Day 4)

Study Sites (1)

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