Traumatic Stress DisorderNCT05097352
Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
A study testing High Intensity Interval Training (HIIT) and Waitlist in people with Traumatic Stress Disorder and Post Traumatic Stress Disorder, run by University of Georgia at 1 site in United States.
Trial summary
This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Traumatic Stress Disorder, Post Traumatic Stress Disorder, Trauma and Stressor Related Disorders
- What is being tested?
- High Intensity Interval Training (HIIT) and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 31 Mar 2023
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- self-reported exposure to a traumatic event
- persistent (> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
- poor sleep quality (Pittsburgh Sleep Quality Index >5)
- failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (<150-mins of moderate or 75-mins of vigorous physical activity [or a combination] per week and/or < 2 days a week of resistance training targeting the major muscle groups).
- able to safely perform high-intensity exercise
- aged 18-39 years
Show all 9Show fewer
- non-smoker
- willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab
- willing to avoid caffeine for 12 hours before visiting the lab
Who cannot join
- Pregnant, lactating, or plans to become pregnant over the next 2 months.
- Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
- Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
- History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
- Pain intensity of 8 or greater in the thigh or foot in the past month
- Probable alcohol use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.
Read the detailed description
A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.
- Conditions
- Traumatic Stress Disorder, Post Traumatic Stress Disorder, Trauma and Stressor Related Disorders, Mental Disorders, Exercise
- Being tested
- High Intensity Interval Training (HIIT), Waitlist
- Medical subject headings
- Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Behavioural
Twenty minutes of HIIT will be completed three days a week for six weeks.
WaitlistOther
Waitlist participants will be tested on the outcomes at the same time points as the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | High-intensity interval training will be performed three times a week for a total of six weeks. Receives: Behavioral: High Intensity Interval Training (HIIT) |
| Waitlist Control | Sham comparator | Waitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group. Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.
Measured: Change from Baseline to week 7
Heart Rate Variability
High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.
Measured: Change from Baseline to Week 7
State Trait Anxiety Inventory (STAI-Y2)
The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.
Measured: Change from Baseline to Week 7
The Posttraumatic Diagnostic Scale-5 (PDS-5)
The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.
Measured: Change from Baseline to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start24 Jan 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick O'Connor, University of Georgia
- Investigators
- Patrick J O'Connor, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097352
- Sponsor's protocol ID
- PROJECT00004322
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGranahan MJ, O'Connor PJ. Effect of high-intensity interval training exercise on sleep quality in women with probable post-traumatic stress disorder: A pilot randomized controlled trial. Sleep Med. 2025 May;129:245-256. doi: 10.1016/j.sleep.2025.02.029. Epub 2025 Feb 21.
PubMed 40056660
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05097352
- Acronym / sponsor ID
- PROJECT00004322
- Conditions
- Traumatic Stress Disorder, Post Traumatic Stress Disorder, Trauma and Stressor Related Disorders, Mental Disorders, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Oct 2021 (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 sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.
Detailed description
A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Behavioral: High Intensity Interval Training (HIIT)High-intensity interval training will be performed three times a week for a total of six weeks. |
| Waitlist Control | Sham comparator | Other: WaitlistWaitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- self-reported exposure to a traumatic event
- persistent (> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
- poor sleep quality (Pittsburgh Sleep Quality Index >5)
- failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (<150-mins of moderate or 75-mins of vigorous physical activity [or a combination] per week and/or < 2 days a week of resistance training targeting the major muscle groups).
- able to safely perform high-intensity exercise
Key exclusion criteria (6 listed)
- Pregnant, lactating, or plans to become pregnant over the next 2 months.
- Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
- Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
- History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
- Pain intensity of 8 or greater in the thigh or foot in the past month
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 |
|---|---|---|
| High Intensity Interval Training (HIIT)Twenty minutes of HIIT will be completed three days a week for six weeks. | Behavioural | High Intensity Interval Training (HIIT) |
| WaitlistWaitlist participants will be tested on the outcomes at the same time points as the treatment group. | Other | Waitlist Control |
Primary outcome
Pittsburg Sleep Quality Index (PSQI)
Time frame: Change from Baseline to week 7
The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.
Heart Rate Variability
Time frame: Change from Baseline to Week 7
High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.
State Trait Anxiety Inventory (STAI-Y2)
Time frame: Change from Baseline to Week 7
The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.
The Posttraumatic Diagnostic Scale-5 (PDS-5)
Time frame: Change from Baseline to Week 7
The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.
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 18 Apr 2023.
- Derived from this study: PubMed 40056660McGranahan MJ, O'Connor PJ. Effect of high-intensity interval training exercise on sleep quality in women with probable post-traumatic stress disorder: A pilot randomized controlled trial. Sleep Med. 2025 May;129:245-256. doi: 10.1016/j.sleep.2025.02.029. Epub 2025 Feb 21.
- 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.
Patrick J O'Connor, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) and Waitlist in people with Traumatic Stress Disorder and Post Traumatic Stress Disorder, run by University of Georgia 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 9 inclusion and 6 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 18 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Pittsburg Sleep Quality Index (PSQI) (time frame: Change from Baseline to week 7). The study lists 4 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 NCT05097352, 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 18 Apr 2023.