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Study of Yoga and Mindfulness for Psychological and Physical Wellness

Primary Purpose

Psychological Trauma, PTSD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga & Meditation
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion/Exclusion Form

ID# __________ Visit: Screening Date: ____________________

Inclusion Criteria (all must be marked "Yes" to be eligible for the study).

  1. Age 18 years or older and military service member active duty or retired Yes ___ No ___
  2. Access to a computer and internet service Yes ___ No ___
  3. Able to read English at 8th grade level or higher. Yes ___ No ___
  4. One or more symptoms endorsed on Appendix B. Yes ___ No ___

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_____

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Yoga and Meditation

    Arm Description

    Yoga and Meditation online sessions 2x's a week.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 10, 2017
    Last Updated
    July 27, 2020
    Sponsor
    University of South Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03059095
    Brief Title
    Study of Yoga and Mindfulness for Psychological and Physical Wellness
    Official Title
    Study of Yoga and Mindfulness for Psychological and Physical Wellness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    September 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of South Florida

    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
    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Trauma, PTSD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    335 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga and Meditation
    Arm Type
    Experimental
    Arm Description
    Yoga and Meditation online sessions 2x's a week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga & Meditation
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    PCL-5: 20 item checklist for symptoms of PTSD (PCL-5)
    Description
    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.
    Time Frame
    Accessing a change from pre, one month, six month and at one year
    Secondary Outcome Measure Information:
    Title
    PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)
    Description
    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.
    Time Frame
    Accessing a change from pre, one month, six month and at one year
    Other Pre-specified Outcome Measures:
    Title
    POQ: 20-item Pain Outcomes Questionnaire (POQ)
    Description
    Short Form is a reliable and valid instrument that contains 19 primary pain items that are rated on an 11-point (0-10) Likert-type scale and one demographic question. In addition to a total pain score, six subscale scores can be calculated that correspond to: pain intensity (1 item), pain-related impairment in mobility (4 items), pain-related impairment in performing activities of daily living (4 items), sense of impairment in activity and energy levels (3 items), dysphoric affect and associated symptoms (5 items), and pain-related fear and avoidance (2 items)
    Time Frame
    Accessing a change from pre, one month, six month and at one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion/Exclusion Form 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 ___ 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_____

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://yogaformen.com/pages/yoga-for-veterans
    Description
    study is all online

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