Study of Yoga and Mindfulness for Psychological and Physical Wellness

NCT03059095 | Completed

• 1 other identifier: Pro00025681
• Study Type: interventional
• Target: 335
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychological Trauma; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PSQI: 15-item Pittsburgh Sleep Quality Index (PSQI)

  Accessing a change from pre, one month, six month and at one year

Other Outcomes (1)

• POQ: 20-item Pain Outcomes Questionnaire (POQ)

  Accessing a change from pre, one month, six month and at one year

Study Arms (1)

Yoga and Meditation

EXPERIMENTAL

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

Behavioral: Yoga & Meditation

Interventions

Yoga & Meditation BEHAVIORAL

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

Yoga and Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \_\_\_

You may not qualify if:

• \. Never served in the military. Yes \_\_\_ No \_\_\_
• Is Subject eligible for participation? Yes\_\_\_\_\_ No\_\_\_\_\_

Sponsors & Collaborators

• University of South Florida: lead

Related Links

• study is all online

MeSH Terms

Conditions

Psychological Trauma; Stress Disorders, Post-Traumatic

Interventions

Yoga; Meditation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share