Clinical trial NCT06123065: Feasibility and Efficacy of A Yoga Intervention for Comorbid Chronic Pain and PTSD
Official title: Yoga for Warriors: A Pilot Study of Feasibility and Efficacy of A Yoga Intervention for Veterans With Comorbid Chronic Pain and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Chronic Pain
Keywords: Yoga
Virtual Intervention
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Virginia Commonwealth University
name: McGuire Research Institute
First posted: 2023-11-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PTSD Checklist for Diagnostic and Statistic Manual for Mental Disorders 5 (DSM-5)
timeFrame: past week; assessed at baseline, mid-treatment (after week 4), post-treatment (after week 8), 3 month follow up
measure: Pain Disability Questionnaire
timeFrame: 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
measure: Pain Catastrophizing Scale
timeFrame: 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:
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Time in intervention; Assessed at post-treatment (8 weeks); Items rated 1 to 4; higher scores indicate better outcomes
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
measure: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
measure: Patient Reported Outcome Measurement Information System (PROMIS) Short Form Anger
timeFrame: 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
measure: Patient Reported Outcome Measurement Information System (PROMIS) Short Form Social Roles
timeFrame: 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
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Current; assessed at baseline, mid-treatment (4 weeks), post-treatment (8 weeks), 3 month follow up; Items rated 1 to 4; higher scores indicate worse outcomes
measure: Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (LES-Q-SF)
timeFrame: past week; assessed at baseline, post-treatment (8 weeks), 3 month follow up; Items rated 1 to 5; higher scores indicate better outcomes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond Veterans Affairs Medical Center
state: Virginia
Study officials:
affiliation: Richmond Veteran Affairs Medical Center
name: Suzzette Chopin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.