Yoga and Physical Activity for Veterans

NCT03509909 | Completed Results DMC

• 2 other identifiers: MHBB-007-17FCX001647-01A1
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is a major health problem for the nation's Veterans, leading to significant physical and mental health morbidity and mortality. Current empirically-supported interventions ameliorate symptoms but generally do not restore full functioning, so the development of alternative or complementary approaches is a critical need. Large numbers of Veterans are seeking out yoga as a part of their recovery plans, but there is not enough evidence to recommend yoga for treatment of PTSD. Likely reflecting this heterogeneity, evidence of yoga's efficacy is highly variable. This project aims to address this problem by comparing the effect of yoga to a matched exercise control condition. The study will also explore the mechanisms by which yoga impacts PTSD. Ultimately, the goal of this research would be to contribute to integrative care planning, whereby multiple approaches can be applied in a synergistic manner to restore wellness for Veterans affected by PTSD.

Conditions

PTSD

Keywords

yoga; exercise; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)

  Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.

  Baseline to post-treatment (approx 12 weeks)

Secondary Outcomes (5)

• Patient Health Questionnaire Depression Items (PHQ-9)

  Baseline to post-treatment (approx 12 weeks)

• State-Trait Anxiety Inventory, State Subscale

  Baseline to post-treatment (approx 12 weeks)

• State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale

  Baseline to post-treatment (approx 12 weeks)

• Insomnia Severity Index

  Baseline to post-treatment (approx 12 weeks)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a

  Baseline to post-treatment (approx 12 weeks)

Study Arms (2)

Hatha yoga

EXPERIMENTAL

12- week group-based yoga class

Behavioral: Hatha yoga

Supportive exercise

ACTIVE COMPARATOR

12-week group-based stretching and strengthening class

Behavioral: Supportive physical activity

Interventions

Hatha yoga BEHAVIORAL

Manualized hatha yoga

Hatha yoga

Supportive physical activity BEHAVIORAL

Manualized stretching and strengthening

Supportive exercise

Eligibility Criteria

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

You may qualify if:

• Veterans who have clinically meaningful PTSD symptoms

You may not qualify if:

• serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months
• a known, untreated substance abuse or dependence problem
• serious mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms
• cognitive impairment that would interfere with treatment
• circumstances that lead to recurrent traumatization
• e.g., engaged in a violent relationship
• any medical condition for which exercise is contraindicated, including pregnancy
• concurrent enrollment in any other treatment specifically targeting PTSD symptoms or in any meditative or mind-body intervention
• including yoga practice \>1 class/month in the preceding 6 months

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Related Publications (1)

• Lang AJ, Malaktaris A, Maluf KS, Kangas J, Sindel S, Herbert M, Bomyea J, Simmons AN, Weaver J, Velez D, Liu L. A randomized controlled trial of yoga vs nonaerobic exercise for veterans with PTSD: Understanding efficacy, mechanisms of change, and mode of delivery. Contemp Clin Trials Commun. 2021 Jan 28;21:100719. doi: 10.1016/j.conctc.2021.100719. eCollection 2021 Mar.

  PMID: 33604485 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ariel J Lang
• Organization: VA San Diego Healthcare System

ariel.lang@va.gov

858-552-8585

Study Officials

• Ariel J. Lang, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome evaluator is blind to experimental condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Experimental condition: Manualized hatha yoga, a 12-session group-based yoga class led by a trained teacher Control condition: Manualized supportive physical activity, a 12-session group-based stretching and strengthening class led by a trained instructor

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 26, 2018
• Study Start: May 16, 2019
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)