Post Traumatic Stress DisorderNCT04288830
Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity
A study testing Tai Chi Moving Mindfulness Meditation and Resilience Training and Aerobic Exercise in people with Post Traumatic Stress Disorder and Tai Chi, run by Johns Hopkins University at 1 site in United States.
Trial summary
The standard of care for PTSD involves both psychotherapy and pharmacotherapy, but treatment resistance is common. The discovery of effective complementary treatment approaches would have major implications for patients with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Tai Chi, Aerobic Exercise
- What is being tested?
- Tai Chi Moving Mindfulness Meditation and Resilience Training and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 27 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For inclusion as a healthy control or a participant with PTSD:
- working in law enforcement
- between the ages of 18 and 65
- Both men and women
- For inclusion as a participant with PTSD:
- previously diagnosed with PTSD by a medical professional (For inclusion in the PTSD group)
- Must meet criteria for PTSD as determined by the PCL-5 instrument on the day of initial assessment.
Who cannot join
- taking sedative or stimulant drugs daily
- physical illness, injury, or disability preventing safe execution of low impact aerobic exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
The standard of care for PTSD involves both psychotherapy and pharmacotherapy, but treatment resistance is common. The discovery of effective complementary treatment approaches would have major implications for patients with PTSD. Mindfulness meditation and related practices have been studied intensively in recent years for a variety of psychiatric illnesses, including depression, generalized anxiety disorder, and PTSD. Studies in PTSD suggest that mindful meditation holds promise. For example, mindfulness-based stress reduction (MBSR) has shown effectiveness for reducing symptom severity and improving mental-health related quality of life in combat-exposed veterans and child survivors of sexual abuse. Mechanistically, mindfulness meditation appears to counteract the types of functional changes that have been identified in the brains of patients with PTSD. In particular, while PTSD symptoms are associated with decreased activation of the prefrontal cortex (PFC) and increased amygdala activity, mindfulness meditation is associated with increased PFC activation and decreased amygdala activation. Other physiological effects of mindfulness meditation in patients with PTSD are not fully defined. However, available data suggest that it leads to a normalization of vagal tone and plasma cortisol levels, which are known to be abnormal in patients with chronic PTSD. Research utilizing validated and standardized pre- and post- PTSD outcome measures, in addition to pre- and post- physiologic variables such a vagal tone, plasma cortisol and catecholamine levels, may better the understandings of physiological effects of mindfulness medication.
Read the detailed description
Post-traumatic stress disorder (PTSD) affects an estimated 4.7% of the United States population every year, leading to increased rates of disability, suicide, substance use, and interpersonal difficulties. Mindfulness interventions for PTSD offer a low-cost, repeatable method that has the potential to induce fear extinction, and that has no known side effects. While several studies have reported the efficacy of mindfulness meditation and related mind-body exercises to reduce self-reported PTSD symptoms, little is known about the physiologic changes associated with mindfulness interventions. The present study seeks to evaluate the effects of a mind-body mindfulness intervention (tai chi) on subjective reports of PTSD symptoms, as well as physiologic correlates of PTSD in a population of law enforcement officers. Tai chi was chosen because its focus on awareness of physical movements is expected to provide an easier mindfulness target, as compared to traditional seated meditation. It is well documented that patients with PTSD, who frequently struggle with intrusive trauma-related memories, are often unable to attend to current circumstances, a problem that leads to exacerbation of symptoms. While there are promising preliminary data suggesting that tai chi leads to improvements in self-reported symptoms of PTSD, there are no data regarding the effects of tai chi on objective endocrine, physiological, and behavioral measures of PTSD.
The investigators hypothesize that the use of the mind-body practice of tai chi will lead to reductions in subjective self-report measures of PTSD as well a normalization of objective physiological correlates of PTSD. In particular, it is hypothesized that the efficacy of tai chi in the treatment of PTSD is hypothesized to be achieved by facilitating fear extinction and augmenting stress resilience through improved integration of mindfulness practices with daily physical activities. To test this hypothesis, the investigators propose the following specific aims:
- Specific Aim 1: To determine the self-reported symptom changes, behavioral changes, and physiological effects that take place during an 8-week intervention of simplified Tai Chi Moving Mindfulness Meditation and Resilience Training (TCMMMRT) in a population of police officers with and without self-reported PTSD. Results from these two groups will also be compared to a control group engaging in aerobic exercise.
- Self-reported outcome measures: Brief Pain Inventory (BPI) short form, Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (PCL-5), and Canadian Occupational Performance Measure (COPM).
- Physiological outcome measures: Mobile Acoustic startle Reflex-monitoring System (MARS) measures, heart rate variability (HRV), cortisol measurements, and actigraphy to monitor sleep patterns and activity levels.
- Conditions
- Post Traumatic Stress Disorder, Tai Chi, Aerobic Exercise
- Being tested
- Tai Chi Moving Mindfulness Meditation and Resilience Training, Aerobic Exercise
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi Moving Mindfulness Meditation and Resilience TrainingBehavioural
Low-impact mind-body exercise adapted from traditional tai chi.
Aerobic ExerciseBehavioural
Low-impact aerobic exercise, led by instructor
| Study group | Role | What they receive |
|---|---|---|
| TCMMMRT First | Experimental | Participants will perform an instructor-led mind-body exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home practice will be logged. At the completion of the TCMMMRT Condition, participants will perform an instructor-led low impact aerobic exercise regimen 1 day per week for a total of 8 weeks. Home exercise will be logged. Receives: Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training; Behavioral: Aerobic Exercise |
| Aerobic Exercise First | Active comparator | Participants will perform an instructor-led low impact aerobic exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home exercise will be logged. At the completion of the aerobic exercise condition, participants will perform an instructor-led mind-body exercise regimen 1 day per week for a total of 8 weeks. Home practice will be logged. Receives: Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training; Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PCL-5 Score
Score on the PTSD Symptom Checklist for DSM-5. The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. The PCL-5 can be used to quantify and monitor symptoms over time, to screen individuals for PTSD, and to assist in making a provisional or temporary diagnosis of PTSD.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Secondary outcomes (7)
Change in BPI score
Brief Pain Inventory - a 9 item self-administered questionnaire used to assess pain severity and the affect of pain on daily functioning. Contains four measures of pain severity on a 0-10 scale and pain interference with 7 life activities on a 0-10 scale. It also includes items to specify pain location and treatments attempted. Across all numbered scales, higher numbers indicate more pain.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in BDI score
Beck Depression Inventory - a 21 item assessment of depressive symptoms. Raw score of 0-13 indicates minimal depression, 14 to 19 indicates mild depression, 20-28 indicates moderate depression, 29-63 indicates severe depression.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in PSQI score
Pittsburgh Sleep Quality Index - a 19 item assessment of different aspects of sleep that yields seven component scores and one component score. The composite scores range from 0 to 21, where lower scores denote a healthier sleep quality. Components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in COPM score
Canadian Occupational Performance Measure - a semi-structured interview that enables assessment of occupational performance problems. It results in two scores of participant-perceived levels of occupational performance. It results in two main scores, performance and satisfaction, each out of 10, with higher numbers reflecting greater performance and satisfaction.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in Salivary Cortisol
Cortisol level in mcg/dL obtained from saliva sample.
Measured: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in Heart Rate Variability
Heart Rate Variability collected using non-invasive Actigraph. Beat to beat intervals will be recorded by the device and output as the standard deviation of nearest neighbor (SDNN) and the square root of the means of the squares of the successive differences between adjacent nearest neighbors (RMSSD).
Measured: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
Change in Acoustic Blink Response
Response to an acoustic tone (milliseconds from tone to eye blink) collected using the Mobile Acoustic startle Reflex-monitoring System (MARS) device
Measured: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start15 Oct 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Una McCann, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288830
- Sponsor's protocol ID
- IRB00226155
- Status last verified
- Jan 2023
- First submitted
- 26 Feb 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity
- ClinicalTrials.gov ID
- NCT04288830
- Acronym / sponsor ID
- IRB00226155
- Conditions
- Post Traumatic Stress Disorder, Tai Chi, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 28 Feb 2020 (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.
The standard of care for PTSD involves both psychotherapy and pharmacotherapy, but treatment resistance is common. The discovery of effective complementary treatment approaches would have major implications for patients with PTSD. Mindfulness meditation and related practices have been studied intensively in recent years for a variety of psychiatric illnesses, including depression, generalized anxiety disorder, and PTSD. Studies in PTSD suggest that mindful meditation holds promise. For example, mindfulness-based stress reduction (MBSR) has shown effectiveness for reducing symptom severity and improving mental-health related quality of life in combat-exposed veterans and child survivors of sexual abuse. Mechanistically, mindfulness meditation appears to counteract the types of functional changes that have been identified in the brains of patients with PTSD. In particular, while PTSD symptoms are associated with decreased activation of the prefrontal cortex (PFC) and increased amygdala activity, mindfulness meditation is associated with increased PFC activation and decreased amygdala activation. Other physiological effects of mindfulness meditation in patients with PTSD are not fully defined. However, available data suggest that it leads to a normalization of vagal tone and plasma cortisol levels, which are known to be abnormal in patients with chronic PTSD. Research utilizing validated and standardized pre- and post- PTSD outcome measures, in addition to pre- and post- physiologic variables such a vagal tone, plasma cortisol and catecholamine levels, may better the understandings of physiological effects of mindfulness medication.
Detailed description
Post-traumatic stress disorder (PTSD) affects an estimated 4.7% of the United States population every year, leading to increased rates of disability, suicide, substance use, and interpersonal difficulties. Mindfulness interventions for PTSD offer a low-cost, repeatable method that has the potential to induce fear extinction, and that has no known side effects. While several studies have reported the efficacy of mindfulness meditation and related mind-body exercises to reduce self-reported PTSD symptoms, little is known about the physiologic changes associated with mindfulness interventions. The present study seeks to evaluate the effects of a mind-body mindfulness intervention (tai chi) on subjective reports of PTSD symptoms, as well as physiologic correlates of PTSD in a population of law enforcement officers. Tai chi was chosen because its focus on awareness of physical movements is expected to provide an easier mindfulness target, as compared to traditional seated meditation. It is well documented that patients with PTSD, who frequently struggle with intrusive trauma-related memories, are often unable to attend to current circumstances, a problem that leads to exacerbation of symptoms. While there are promising preliminary data suggesting that tai chi leads to improvements in self-reported symptoms of PTSD, there are no data regarding the effects of tai chi on objective endocrine, physiological, and behavioral measures of PTSD.
The investigators hypothesize that the use of the mind-body practice of tai chi will lead to reductions in subjective self-report measures of PTSD as well a normalization of objective physiological correlates of PTSD. In particular, it is hypothesized that the efficacy of tai chi in the treatment of PTSD is hypothesized to be achieved by facilitating fear extinction and augmenting stress resilience through improved integration of mindfulness practices with daily physical activities. To test this hypothesis, the investigators propose the following specific aims:
- Specific Aim 1: To determine the self-reported symptom changes, behavioral changes, and physiological effects that take place during an 8-week intervention of simplified Tai Chi Moving Mindfulness Meditation and Resilience Training (TCMMMRT) in a population of police officers with and without self-reported PTSD. Results from these two groups will also be compared to a control group engaging in aerobic exercise.
- Self-reported outcome measures: Brief Pain Inventory (BPI) short form, Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (PCL-5), and Canadian Occupational Performance Measure (COPM).
- Physiological outcome measures: Mobile Acoustic startle Reflex-monitoring System (MARS) measures, heart rate variability (HRV), cortisol measurements, and actigraphy to monitor sleep patterns and activity levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCMMMRT First | Experimental | Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training, Behavioral: Aerobic ExerciseParticipants will perform an instructor-led mind-body exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home practice will be logged. At the completion of the TCMMMRT Condition, participants will perform an instructor-led low impact aerobic exercise regimen 1 day per week for a total of 8 weeks. Home exercise will be logged. |
| Aerobic Exercise First | Active comparator | Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training, Behavioral: Aerobic ExerciseParticipants will perform an instructor-led low impact aerobic exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home exercise will be logged. At the completion of the aerobic exercise condition, participants will perform an instructor-led mind-body exercise regimen 1 day per week for a total of 8 weeks. Home practice will be logged. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- working in law enforcement
- between the ages of 18 and 65
- Both men and women
- previously diagnosed with PTSD by a medical professional (For inclusion in the PTSD group)
- Must meet criteria for PTSD as determined by the PCL-5 instrument on the day of initial assessment.
Key exclusion criteria (2 listed)
- taking sedative or stimulant drugs daily
- physical illness, injury, or disability preventing safe execution of low impact aerobic exercise
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 |
|---|---|---|
| Tai Chi Moving Mindfulness Meditation and Resilience TrainingLow-impact mind-body exercise adapted from traditional tai chi. | Behavioural | Aerobic Exercise First, TCMMMRT First |
| Aerobic ExerciseLow-impact aerobic exercise, led by instructor | Behavioural | Aerobic Exercise First, TCMMMRT First |
Primary outcome
Change in PCL-5 Score
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Score on the PTSD Symptom Checklist for DSM-5. The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. The PCL-5 can be used to quantify and monitor symptoms over time, to screen individuals for PTSD, and to assist in making a provisional or temporary diagnosis of PTSD.
7 secondary outcomes
Change in BPI score
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in BDI score
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in PSQI score
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in COPM score
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in Salivary Cortisol
Time frame: Assessed on Day 1, Day 56, Day 112, and Day 168
Change in Heart Rate Variability
Time frame: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
Change in Acoustic Blink Response
Time frame: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
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 11 Apr 2023.
- 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.
Una McCann principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Moving Mindfulness Meditation and Resilience Training and Aerobic Exercise in people with Post Traumatic Stress Disorder and Tai Chi, run by Johns Hopkins University 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 7 inclusion and 2 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 11 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. 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?
Change in PCL-5 Score (time frame: Assessed on Day 1, Day 56, Day 112, and Day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2023.