Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder

NCT04417309 | Withdrawn

• 1 other identifier: 58938
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Women, Exercise, Mental Health

Outcome Measures

Primary Outcomes (4)

• Participant Skin Conductance Responding (SCR)

  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.

  up to Day 4

• Participant Expectancy Ratings

  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.

  Up to day 4

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

  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.

  before and after 30 min exercise on Day 3

• Group Differences in Serum Endocannabinoid (eCB) Content

  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.

  before and after 30 min exercise on Day 3

Secondary Outcomes (3)

• Change in Profile of Mood States (POMS) Questionnaire

  at each visit, up to Day 4

• 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

Study Arms (2)

Moderate Intensity Exercise

EXPERIMENTAL

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

Behavioral: Experimental

Control

ACTIVE COMPARATOR

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

Behavioral: Active Control

Interventions

Experimental BEHAVIORAL

Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes.

Moderate Intensity Exercise

Active Control BEHAVIORAL

Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at \~50% of MHR) for 30 minutes.

Control

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Adams: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40505, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior; Personal Satisfaction

Study Officials

• Thomas G Adams Jr, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: May 8, 2020
• Primary Completion: May 21, 2020
• Study Completion: November 1, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)