Exercise and Therapeutic Learning Among Women With PTSD

NCT04113798 | Completed

• 4 other identifiers: 2018-0845A538900SMPH/PSYCHIATRY/PSYCHIATRYProtocol Version 11/4/2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD

Keywords

women; exercise; mental health

Outcome Measures

Primary Outcomes (3)

• 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

• 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

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: Low Intensity Exercise; Other: Day 4 Recall of Fear Extinction

Interventions

Day 1 Assessments OTHER

Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)

Control; Moderate Intensity Exercise

Day 2 Fear Learning OTHER

Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.

Control; Moderate Intensity Exercise

Day 3 Fear Extinction OTHER

Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.

Control; Moderate Intensity Exercise

Moderate Intensity Exercise BEHAVIORAL

The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3

Moderate Intensity Exercise

Low Intensity Exercise BEHAVIORAL

Control participants will maintain light-intensity activity (i.e., walking at \~50% of MHR) for the full duration of 30 minutes.

Control

Day 4 Recall of Fear Extinction OTHER

During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur \~24 hours following Day 3, and lasts about 30 minutes.

Control; Moderate Intensity Exercise

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

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53719, United States

Location

Related Publications (1)

• Crombie KM, Sartin-Tarm A, Sellnow K, Ahrenholtz R, Lee S, Matalamaki M, Adams TG, Cisler JM. Aerobic exercise and consolidation of fear extinction learning among women with posttraumatic stress disorder. Behav Res Ther. 2021 Jul;142:103867. doi: 10.1016/j.brat.2021.103867. Epub 2021 Apr 27.

  PMID: 34020153 DERIVED

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

• Josh Cisler, PhD

  University of Wisconsin, Madison

  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

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: April 8, 2019
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)