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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06123065
• Other study ID #: 1572859
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2023
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	Richmond Veterans Affairs Medical Center	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	McGuire Research Institute, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Client Satisfaction Questionnaire-8 (CSQ-8)	Th CSQ is an 8-item measure assesses general intervention satisfaction	Time in intervention; Assessed at post-treatment (8 weeks); Items rated 1 to 4; higher scores indicate better outcomes
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 assesses depression severity	Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Secondary	Generalized Anxiety Disorder 7-Item Scale (GAD-7)	The GAD-7 measures anxiety experienced	Past 2 weeks; assessed at baseline and post-treatment (8 weeks); Items rated 0 to 3; higher scores indicate worse outcomes
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) Short Form Anger	Assesses emotional distress and anger (5 items)	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
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) Short Form Social Roles	Assesses ability to participate in social roles and activities	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
Secondary	Tampa Scale for Kinesiophobia (TSK-11)	The TSK-11 is an 11-item scale used to measure general perceptions of pain interference	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
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (LES-Q-SF)	The Q-LES-Q-SF is a 16-item scale used to measure quality of life	past week; assessed at baseline, post-treatment (8 weeks), 3 month follow up; Items rated 1 to 5; higher scores indicate better outcomes