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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
8 week Yoga for chronic pain and PTSD group intervention, conducted virtually
Richmond Veterans Affairs Medical Center
Richmond, Virginia, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Client Satisfaction Questionnaire-8 (CSQ-8)
Th CSQ is an 8-item measure assesses general intervention satisfaction
Time frame: 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)
The PHQ-9 assesses depression severity
Time frame: 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)
The GAD-7 measures anxiety experienced
Time frame: 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
Assesses emotional distress and anger (5 items)
Time frame: 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
Assesses ability to participate in social roles and activities
Time frame: 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
Tampa Scale for Kinesiophobia (TSK-11)
The TSK-11 is an 11-item scale used to measure general perceptions of pain interference
Time frame: 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
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
Time frame: past week; assessed at baseline, post-treatment (8 weeks), 3 month follow up; Items rated 1 to 5; higher scores indicate better outcomes
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