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

Primary Purpose

PTSD

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental
Active Control
Sponsored by
Thomas Adams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Women, Exercise, Mental Health

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moderate Intensity Exercise

Control

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Change in Profile of Mood States (POMS) Questionnaire
The POMS survey is a 65-item survey scored on a 5 point Likert Scale (0-4) where 0 s 'not at all' and 4 is 'extremely' for the tension, depression, fatigue, confusion, and anger subscales, and reversed for the vigor and esteem-related affect subscales. The range of total possible scores is XX-XX with higher numbers indicating more extreme or negative moods.
Change in State-Trait Anxiety Inventory (STAI)
STAI is a 20-item assessment rated on a 4-point scale from 'almost never' to 'almost always' with the total scores ranging from 20-80. Higher scores indicate greater anxiety.
Change in Positive and Negative Affect Scale (PANAS)
PANAS is comprised of two 10-item scales for both positive and negative affect. Total combine scoring is from 20-100 where the higher the score the more negative the affect.

Full Information

First Posted
June 1, 2020
Last Updated
June 22, 2021
Sponsor
Thomas Adams
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1. Study Identification

Unique Protocol Identification Number
NCT04417309
Brief Title
Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder
Acronym
PTSD
Official Title
Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 prevented recruitment/enrollment of participants.
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Adams

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Women, Exercise, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Intensity Exercise
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for 30 minutes.
Primary Outcome Measure Information:
Title
Participant Skin Conductance Responding (SCR)
Description
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.
Time Frame
up to Day 4
Title
Participant Expectancy Ratings
Description
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.
Time Frame
Up to day 4
Title
Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)
Description
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.
Time Frame
before and after 30 min exercise on Day 3
Title
Group Differences in Serum Endocannabinoid (eCB) Content
Description
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.
Time Frame
before and after 30 min exercise on Day 3
Secondary Outcome Measure Information:
Title
Change in Profile of Mood States (POMS) Questionnaire
Description
The POMS survey is a 65-item survey scored on a 5 point Likert Scale (0-4) where 0 s 'not at all' and 4 is 'extremely' for the tension, depression, fatigue, confusion, and anger subscales, and reversed for the vigor and esteem-related affect subscales. The range of total possible scores is XX-XX with higher numbers indicating more extreme or negative moods.
Time Frame
at each visit, up to Day 4
Title
Change in State-Trait Anxiety Inventory (STAI)
Description
STAI is a 20-item assessment rated on a 4-point scale from 'almost never' to 'almost always' with the total scores ranging from 20-80. Higher scores indicate greater anxiety.
Time Frame
at each visit, up to Day 4
Title
Change in Positive and Negative Affect Scale (PANAS)
Description
PANAS is comprised of two 10-item scales for both positive and negative affect. Total combine scoring is from 20-100 where the higher the score the more negative the affect.
Time Frame
at each visit, up to Day 4

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Adams Jr, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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