Feasibility and Efficacy of A Yoga Intervention for Comorbid Chronic Pain and PTSD

NCT06123065 | Completed

• 1 other identifier: 1572859
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot quasi-randomized study is test the feasibility, acceptability, and initial efficacy of Yoga for Warriors treatment program for comorbid chronic pain and PTSD, conducted virtually through the Richmond Veterans Affairs Medical Center (RICVAMC). the main questions it aims to answer are:

1. 1.Whether a virtual intervention for chronic pain and PTSD is feasible and acceptable for veterans.
2. 2.Using a wait-list control group design, to determine preliminary efficacy of the intervention.
3. 3.Examine follow-up data to determine if benefits are maintained over time.

Conditions

PTSD; Chronic Pain

Keywords

Yoga; Virtual Intervention

Outcome Measures

Primary Outcomes (3)

• PTSD Checklist for Diagnostic and Statistic Manual for Mental Disorders 5 (DSM-5)

  Assess current symptoms of PTSD in line with DSM-5 criteria (20 items)

  past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up

• Pain Disability Questionnaire

  Assesses self report of impact of pain in functioning (15 items)

  past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated on 1 to 10-point scale; higher scores indicate worse outcome

• Pain Catastrophizing Scale

  Assesses self report of thoughts and worries related to chronic pain (13 items)

  current; past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up; Items rated 0 to 4; higher scores indicate worse outcomes

Secondary Outcomes (7)

• Client Satisfaction Questionnaire-8 (CSQ-8)

  Time in intervention; Assessed at post-treatment (8 weeks); Items rated 1 to 4; higher scores indicate better outcomes

• Patient Health Questionnaire-9 (PHQ-9)

  Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes

• Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes

• Patient Reported Outcome Measurement Information System (PROMIS) Short Form Anger

  Past 7 days; assessed at baseline and post-treatment (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean worse outcomes

• Patient Reported Outcome Measurement Information System (PROMIS) Short Form Social Roles

  Past 7 days; assessed at baseline and post-treatment; (8 weeks); Items rated 1 to 5; raw scores converted to T scores; higher scores mean better outcomes

Study Arms (2)

Active

EXPERIMENTAL

Immediately enrolled into Yoga intervention. Completed orientation and baseline measures then began 8-week yoga group intervention.

Behavioral: Yoga

Waitlist

OTHER

Delayed Intervention. Waitlist individuals attended orientation and completed baseline measures. After completion of re-assessment of measures 8 weeks later, then enrolled into Active arm.

Behavioral: Yoga

Interventions

Yoga BEHAVIORAL

8 week Yoga for chronic pain and PTSD group intervention, conducted virtually

Also known as: Complementary and Alternative Intervention

Active; Waitlist

Eligibility Criteria

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

You may qualify if:

• Diagnosis of chronic pain (defined as pain for \> 3 months) in the electronic medical record and a score of 50 or more on the Pain Disability Questionnaire (PDQ)
• Probable PTSD defined as being above the clinical threshold on the PTSD Checklist for DSM-5 (PCL-5), sum score at or above 25
• Able to stand up from sitting on the floor without assistance
• Able to ambulate community distances without an assistive device
• Intact sensation in lower extremities below knees
• Medical clearance by primary care provider
• Access to a computer/laptop/ipad with internet and video capability.

You may not qualify if:

• Fall risk
• Pregnancy
• Joint replacement within the past 12 months
• Active alcohol/other substance abuse or dependence (unless actively engaged in treatment)
• Current psychotic disorder or hospitalization with psychotic symptoms in past 3 months
• Active (past 3 months) suicidal or homicidal ideation.

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Virginia Commonwealth University: collaborator
• McGuire Research Institute: collaborator

Study Sites (1)

Richmond Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (2)

• Chopin SM, Sheerin CM, Meyer BL. Yoga for warriors: An intervention for veterans with comorbid chronic pain and PTSD. Psychol Trauma. 2020 Nov;12(8):888-896. doi: 10.1037/tra0000649. Epub 2020 Jul 23.

  PMID: 32700935 BACKGROUND

• Chopin SM, Zaur AJ, Fountain C, Claros Nunez A, Sheerin CM. Feasibility of a Virtual Adaptation of a Yoga Intervention for Veterans with Chronic Pain and Posttraumatic Stress Disorder. J Integr Complement Med. 2025 Jan;31(1):92-99. doi: 10.1089/jicm.2024.0512. Epub 2024 Sep 10.

  PMID: 39253832 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Suzzette Chopin, Ph.D.

  Richmond Veteran Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Model Details: Delayed cross-over design, with a Waitlist control. This study was a quasi-randomization to Active or Waitlist and Waitlist individuals were then moved to the Active group after assessment.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 8, 2023
• Study Start: April 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Starting 6 months following publication of primary dataset. Data will remain available for up to 10 years.
• Access Criteria: Qualified researchers (i.e., based on degree and institutional support) who request de-identified data from study PI (listed as corresponding author) following publication of primary paper. Relevant data dictionaries and analytic scripts may also be shared through encrypted email or file-sharing programs. PI/corresponding author will review requests and make final approval decisions for data sharing.

Locations

US (1)