Comparing Effects of a Holistic Yoga Program and a Wellness Program on PTSD Symptoms

NCT02234622 | Completed Results

• 1 other identifier: D1487-R
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

Given the limited effectiveness of current treatments and the burden PTSD places on Veterans, civilians and clinicians, this research aims to compare the effects of a standardized, traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-Traumatic; Yoga; Veterans

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS-5)

  The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.

  Change from baseline to 16 weeks (end of treatment)

• PTSD Checklist

  PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.

  Change from baseline to 16 weeks (end of treatment)

Secondary Outcomes (5)

• Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II

  Change from baseline to 16 weeks (end of treatment)

• Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a

  Change from baseline to 16 weeks (end of treatment)

• Beck Depression Inventory-II

  Change from baseline to 16 weeks (end of treatment)

• Spielberger State-Trait Anxiety (STAI) - State Subscale

  Change from baseline to 16 weeks (end of treatment)

• Brief Pain Inventory (BPI) Item #3

  Change from baseline to 16 weeks (end of treatment)

Study Arms (2)

Holistic Yoga Program

EXPERIMENTAL

The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.

Behavioral: Holistic Yoga Program

Wellness Lifestyle Program

ACTIVE COMPARATOR

The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.

Behavioral: Wellness Lifestyle Program

Interventions

Holistic Yoga Program BEHAVIORAL

The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.

Also known as: HYP

Holistic Yoga Program

Wellness Lifestyle Program BEHAVIORAL

The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.

Also known as: WLP

Wellness Lifestyle Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• they are age 18 or older,
• have a Clinician Administered PTSD Scale-confirmed PTSD diagnosis,
• and access to a working telephone for ease of contact during the course of the study.

You may not qualify if:

• severe medical conditions in which yoga is contraindicated;
• active psychosis;
• active suicidal intent;
• moderate to severe cognitive impairment as determined by the short Mini-Mental State Examination, a six-item screener (MMSE);
• involvement in ongoing yoga classes and/or regular home practice of yoga in the previous 3 months;
• and receiving ongoing medical or psychological treatment that includes more than one hour weekly of relaxation and mind-body based stress reduction strategies (related directly to meditation and yoga).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

All participants were from one large city in the Midwest. The yoga intervention was designed to address PTSD by a yoga therapist who trained the yoga teacher assistants and may not apply to all types of yoga classes.

Results Point of Contact

• Title: Louanne Davis Psy.D.
• Organization: Roudebush VA Medical Center

louannedavis52@gmail.com

317-710-1338

Study Officials

• Louanne W Davis, PsyD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 9, 2014
• Study Start: August 3, 2015
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)