Study of Yoga and Mindfulness for Psychological and Physical Wellness

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Psychological Trauma
• Intervention / Treatment: Behavioral: Yoga & Meditation

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 Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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_____

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Yoga and Meditation; Yoga and Meditation online sessions 2x's a week.	Behavioral: Yoga & Meditation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Accessing a change from pre, one month, six month and at one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Accessing a change from pre, one month, six month and at one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
POQ: 20-item Pain Outcomes Questionnaire (POQ)	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)	Accessing a change from pre, one month, six month and at one year

Collaborators and Investigators

• Sponsor: University of South Florida

Publications and helpful links

Helpful Links

• study is all online

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Psychological Trauma
• Other Study ID Numbers: Pro00025681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No