Psychological TraumaNCT03059095
Study of Yoga and Mindfulness for Psychological and Physical Wellness
A study testing Yoga & Meditation in people with Psychological Trauma and PTSD, run by University of South Florida.
Trial summary
The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and meditation classes report changes in symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Trauma, PTSD
- What is being tested?
- Yoga & Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ID# Visit: Screening Date:
- Inclusion Criteria (all must be marked "Yes" to be eligible for the study).
- Age 18 years or older and military service member active duty or retired Yes ___ No ___
- Access to a computer and internet service Yes ___ No ___
- Able to read English at 8th grade level or higher. Yes ___ No ___
- One or more symptoms endorsed on Appendix B. Yes ___ No ___
Show all 9Show fewer
- Exclusion Criteria (must be marked "No" to be eligible for the study).
- 1. Never served in the military. Yes No
- Is Subject eligible for participation? Yes No
Who cannot join
None listed.
About this study
The study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and meditation classes report changes in symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month period will provide information on the trajectory of change in symptom status, as well as insight into the extent to which this program may be an effective modality for veterans and service members who are experiencing symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The purpose of this study is to evaluate whether the existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and related conditions.
Read the detailed description
Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation. It is designed to bring balance and health to the physical, mental, emotional, and spiritual dimensions of the individual.
A recent systematic review of 17 studies published between the years 2011-2013 reported that most studies of yoga demonstrated positive changes in psychological or physiological outcomes related to stress. In addition, the practice of yoga also seems to be associated with moderate improvements in cognitive function , which in turn, may be expected to positively impact overall psychological well-being. These selected results provide a strong rationale to examine the effects of yoga for a range of health conditions, in addition to across various setting and by use of different delivery methods.
Much of the research on mindfulness has been in the area of anxiety and depression. Evidence suggests that mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner , can result in reduced symptoms of depression and anxiety .
- Conditions
- Psychological Trauma, PTSD
- Being tested
- Yoga & Meditation
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga & MeditationBehavioural
Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation.mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner
| Study group | Role | What they receive |
|---|---|---|
| Yoga and Meditation | Experimental | Yoga and Meditation online sessions 2x's a week. Receives: Behavioral: Yoga & Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL-5: 20 item checklist for symptoms of PTSD (PCL-5)
There are several different ways of interpreting the scores given by the PTSD Checklist-5.[5] For a person to have a probable diagnosis of PTSD sufficient criteria must be at least moderately met in each of the four symptom groups.[1] This means you need to have one or more symptoms from questions 1 to 5, either question 6 or 7, two or more from questions 8 to 14, and two or more from questions 15 to 20, each of which must be met moderately, quite a bit or extremely.[1] In addition, a score of 38 or higher indicates probable PTSD in veterans.
Measured: Accessing a change from pre, one month, six month and at one year
Secondary outcomes (1)
PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)
measures quality and patterns of sleep in adults. It takes an estimated 3 to 6 minutes to complete. A global PSQI score greater than 5 has yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p<0.001) in distinguishing good and poor sleepers. Internal consistency reliability has been estimated to range from .77 to .81.
Measured: Accessing a change from pre, one month, six month and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Sep 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059095
- Sponsor's protocol ID
- Pro00025681
- Status last verified
- Jul 2020
- First submitted
- 10 Feb 2017
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Yoga and Mindfulness for Psychological and Physical Wellness
- ClinicalTrials.gov ID
- NCT03059095
- Acronym / sponsor ID
- Pro00025681
- Conditions
- Psychological Trauma, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 Feb 2017 (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 study rationale is to analyze the extent to which adult U.S. or non U.S. veterans or active duty military personnel who participate in the Yoga for Men (YfM) online Yoga and meditation classes report changes in symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The serial measurement of symptom status over a 12-month period will provide information on the trajectory of change in symptom status, as well as insight into the extent to which this program may be an effective modality for veterans and service members who are experiencing symptoms of psychological trauma, depression, anxiety, stress, sleep quality, and pain. The purpose of this study is to evaluate whether the existing YfM online program is helpful to study qualifying veterans with symptoms of PTSD and related conditions.
Detailed description
Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation. It is designed to bring balance and health to the physical, mental, emotional, and spiritual dimensions of the individual.
A recent systematic review of 17 studies published between the years 2011-2013 reported that most studies of yoga demonstrated positive changes in psychological or physiological outcomes related to stress. In addition, the practice of yoga also seems to be associated with moderate improvements in cognitive function , which in turn, may be expected to positively impact overall psychological well-being. These selected results provide a strong rationale to examine the effects of yoga for a range of health conditions, in addition to across various setting and by use of different delivery methods.
Much of the research on mindfulness has been in the area of anxiety and depression. Evidence suggests that mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner , can result in reduced symptoms of depression and anxiety .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga and Meditation | Experimental | Behavioral: Yoga & MeditationYoga and Meditation online sessions 2x's a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ID# Visit: Screening Date:
- Inclusion Criteria (all must be marked "Yes" to be eligible for the study).
- Age 18 years or older and military service member active duty or retired Yes ___ No ___
- Access to a computer and internet service Yes ___ No ___
- Able to read English at 8th grade level or higher. Yes ___ No ___
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Yoga & MeditationYoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation.mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner | Behavioural | Yoga and Meditation |
Primary outcome
PCL-5: 20 item checklist for symptoms of PTSD (PCL-5)
Time frame: Accessing a change from pre, one month, six month and at one year
There are several different ways of interpreting the scores given by the PTSD Checklist-5.[5] For a person to have a probable diagnosis of PTSD sufficient criteria must be at least moderately met in each of the four symptom groups.[1] This means you need to have one or more symptoms from questions 1 to 5, either question 6 or 7, two or more from questions 8 to 14, and two or more from questions 15 to 20, each of which must be met moderately, quite a bit or extremely.[1] In addition, a score of 38 or higher indicates probable PTSD in veterans.
1 secondary outcome
PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)
Time frame: Accessing a change from pre, one month, six month and at one year
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 28 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga & Meditation in people with Psychological Trauma and PTSD, run by University of South Florida.
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 0 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
PCL-5: 20 item checklist for symptoms of PTSD (PCL-5) (time frame: Accessing a change from pre, one month, six month and at one year). 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 28 Jul 2020.