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

Chronic Pain Clinical Trial

Official title: Yoga for Warriors: A Pilot Study of Feasibility and Efficacy of A Yoga Intervention for Veterans With Comorbid Chronic Pain and PTSD

Status Completed

Clinical Trial 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. Whether a virtual intervention for chronic pain and PTSD is feasible and acceptable for veterans.

2. Using a wait-list control group design, to determine preliminary efficacy of the intervention.

3. Examine follow-up data to determine if benefits are maintained over time.

Clinical Trial Description

The study will be a pilot quasi-randomized controlled design comparing the 8-session Yoga for Warriors program, conducted via a web-based platform, utilizing a wait-list control, with wait-list participants being enrolled in subsequent groups. Measures of treatment satisfaction will be given and rates of initiation following screening and drop-out will be measured. A battery of assessments will be given at baseline (group introduction), at mid-point (around session 4), and following completion of the group. To determine maintenance effects, select assessments and re-administration of the study assessment battery will be conducted 3 months post-completion.

Potentially interested participants will be screened for eligibility. Screening for eligibility will occur over the phone and those who are interested in participating and willing to engage in the online format and who meet inclusion criteria based on study staff screening will go through the informed consent process over the phone or virtually. Collection of informed consent from participants will not include written documentation of informed consent given the fully virtual nature of this study during the coronavirus pandemic (COVID-19) restrictions (waiver of documentation of consent has been submitted). Paperless recording of willingness to participate will take place, with no written documentation of consent to participate. Participants will attend an initial online orientation session (prior to the first yoga session), either in a group format or individually, where they will be provided information on the group, will be randomized into the treatment group or to the wait-list control group. To attend the orientation session and all yoga sessions, participants will be emailed the specific, secured link to the online platform. Participants will complete the measures over the phone with the study coordinator. This will be an 8 week (+1 orientation session) group conducted remotely, online, with additional self-report measures completed mid-treatment, post-treatment, and at follow-up, in the same manner as described above. ;

Related Conditions & MeSH terms

• Chronic Pain
• PTSD

• NCT number: NCT06123065
• Study type: Interventional
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Completion date: August 30, 2022