PTSDNCT04113798
Exercise and Therapeutic Learning Among Women With PTSD
A study testing Day 1 Assessments, Day 2 Fear Learning and Day 3 Fear Extinction in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Day 1 Assessments, Day 2 Fear Learning and Day 3 Fear Extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 21 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- English speaking
- Medically healthy
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Day 1 Assessments, Day 2 Fear Learning, Day 3 Fear Extinction, Moderate Intensity Exercise, Low Intensity Exercise
- Keywords
- women, exercise, mental health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day 1 AssessmentsOther
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)
Day 2 Fear LearningOther
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.
Day 3 Fear ExtinctionOther
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.
Moderate Intensity ExerciseBehavioural
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
Low Intensity ExerciseBehavioural
Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for the full duration of 30 minutes.
Day 4 Recall of Fear ExtinctionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: before and after 30 min exercise on Day 3
Secondary outcomes (3)
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.
Measured: at each visit, up to Day 4
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.
Measured: at each visit, up to Day 4
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.
Measured: at each visit, up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start8 Apr 2019
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josh Cisler, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113798
- Sponsor's protocol ID
- 2018-0845
- Other IDs
- A538900, SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 11/4/2019
- Status last verified
- Jun 2020
- First submitted
- 1 Oct 2019
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34020153
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Therapeutic Learning Among Women With PTSD
- ClinicalTrials.gov ID
- NCT04113798
- Acronym / sponsor ID
- 2018-0845
- Conditions
- PTSD
- Keywords
- women, exercise, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Exercise | Experimental | Other: Day 1 Assessments, Other: Day 2 Fear Learning, Other: Day 3 Fear Extinction, Behavioral: Moderate Intensity Exercise, Other: Day 4 Recall of Fear ExtinctionDay 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by moderate intensity exercise), Day 4 Recall of Fear Extinction |
| Control | Active comparator | Other: Day 1 Assessments, Other: Day 2 Fear Learning, Other: Day 3 Fear Extinction, Behavioral: Low Intensity Exercise, Other: Day 4 Recall of Fear ExtinctionDay 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by low intensity exercise), Day 4 Recall of Fear Extinction |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
- English speaking
- Medically healthy
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day 1 AssessmentsStructured 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) | Other | Control, Moderate Intensity Exercise |
| Day 2 Fear LearningParticipants 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. | Other | Control, Moderate Intensity Exercise |
| Day 3 Fear ExtinctionParticipants 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. | Other | Control, Moderate Intensity Exercise |
| Moderate Intensity ExerciseThe 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 | Behavioural | Moderate Intensity Exercise |
| Low Intensity ExerciseControl participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for the full duration of 30 minutes. | Behavioural | Control |
| Day 4 Recall of Fear ExtinctionDuring 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. | Other | Control, Moderate Intensity Exercise |
Primary outcome
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 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.
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.
3 secondary outcomes
Change in Profile of Mood States (POMS) Questionnaire
Time frame: at each visit, up to Day 4
Change in State-Trait Anxiety Inventory (STAI)
Time frame: at each visit, up to Day 4
Change in Positive and Negative Affect Scale (PANAS)
Time frame: at each visit, up to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 34020153Crombie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Cisler, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day 1 Assessments, Day 2 Fear Learning and Day 3 Fear Extinction in people with PTSD, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Skin Conductance Responding (SCR) (time frame: up to Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.