Chronic Low Back Pain, Chronic Neck Pain, Post-Traumatic Stress Disorder
Conditions
Keywords
PTSD, chronic pain, yoga, mantram repetition, mind-body interventions, complementary and integrative medicine
Brief summary
PTSD is prevalent among Veterans and is associated with physical and functional impairments in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and pain-related functional limitations than Veterans without PTSD. Mind-body interventions such as yoga and meditation are non-pharmacological options for treating both chronic pain and PTSD. This pilot study will add an existing mantram repetition (MR) component designed for Veterans with PTSD to an active yoga intervention known to improve function in chronic back pain patients. The study will examine the acceptability of the interventions, adverse events, and the feasibility of recruitment, attendance, retention, treatment fidelity, and assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or to a relaxation/health education control. Health outcomes including pain-related function, pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a full-scale trial of enhanced yoga for pain in VA patients with PTSD.
Detailed description
The objectives of the proposed project are to examine the feasibility of delivering a combined yoga and MR intervention to VA patients with PTSD and cLBP and/or cNP within a randomized controlled trial study design. MR enhances the active yoga intervention for this specific population by providing a portable tool for managing stress and anxiety, and improving mental and emotional functioning in situations of daily life. The investigators will recruit and randomize 32 Veterans with PTSD to either enhanced yoga interventions or a relaxation/health education (R/HE) comparison intervention. The goal of the pilot randomized trial is to demonstrate the acceptability of the interventions, to study the feasibility of recruitment, retention, adherence, randomization, and assessments with military Veterans with PTSD, and to measure any adverse events. Data will inform plans for a full-scale effectiveness RCT. Researchers and content experts will adapt and blend two manualized interventions (MR and yoga) into a single manualized and acceptable intervention. In addition, the existing yoga intervention and MR manuals will be adapted to provide a structured intervention guide for instructors. Next, the investigators will recruit and screen 32 Veterans with PTSD. Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included. The investigators will track and measure adverse events, recruitment rates, attendance and home practice rates, use of MR and yoga principles in daily life, attrition rates, and time to complete assessments. Questionnaires will assess pain-related function, pain, PTSD symptoms, insomnia/sleep, alcohol use, and quality of life. The investigators will also conduct qualitative interviews with 12 study participants to examine acceptability, recommendations, and factors affecting attendance and attrition. The investigators will target 7-8 yoga participants and 4-5 control participants. Data will be used to plan a full-scale RCT powered to detect differences in health outcomes.
Interventions
BEHAVIORALYoga and Mantram Repetition
An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
BEHAVIORALVeteran Calm
A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to which intervention is hypothesized to be superior, but are aware of the intervention they are assigned to. All assessments are self-report and do not require interpretation by study investigators.
Intervention model description
Eligible participants will be randomized to either the enhanced yoga interventions or the (R/HE) comparison intervention. Assessments will occur at baseline, 12-weeks, and again 6-weeks after the intervention ends (18-weeks). The enhanced yoga intervention will consist of 1x weekly instructor-led yoga sessions lasting approximately 75 minutes, augmented by home practice of yoga for 20 minutes/day. The R/HE control intervention will be manualized and will meet weekly for 12 weeks for approximately 75 minutes per week. Short homework assignments will be included.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans Affairs (VA) patients * age \> 18 * current diagnosis of PTSD * score of 25 on Montreal Cognitive Assessment (MoCA) * willing to reduce or cease opioid medications * willing to attend 12-weeks of mind-body interventions and complete 3 assessments
Exclusion criteria
* serious or unstable psychiatric illness * e.g. psychosis, mania * suicidal or homicidal ideation * \< 3 months since major trauma event * moderate or severe cognitive impairment * practiced yoga or mantram repetition \> 2x in the last 6 months * coexisting medical illness with yoga contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMDQ) | Change between baseline and 12-weeks | The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5) | Change between baseline and 12-weeks | The PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD. Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms. |
| BPI Pain Interference | change from baseline to 12 weeks | Brief Pain Inventory Pain Interference - The total score is the mean of the 7 pain interference items. Scores range from 0-10 with higher scores indicating greater pain interference. |
| Insomnia Severity Index (ISI) | Change between baseline and 12-weeks | Insomnia Severity Index is a 7-item instrument that assesses the impact of insomnia. Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia. |
| BPI Pain Severity | change from baseline to 12 weeks | Brief Pain Inventory Pain Severity - The total score is the mean of the 4 pain severity items. Scores range from 0-10 with higher scores indicating greater pain severity. |
| AUDIT-C | Change between baseline and 12-weeks | AUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period. The measure has questions on typical consumption and binge drinking frequency. Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems. |
| Fatigue | change from baseline to 12 weeks | Fatigue Severity Scale - The scale consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63. Higher scores reflect greater fatigue severity and less energy. |
| Quality of Life - EQ5D | Change between baseline and 12-weeks | Health-related Quality of Life will be measured with the EQ5D-3L. Scores range from 0 to 1.0 with higher scores indicating better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Yoga and Mantram Repetition An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
Yoga and Mantram Repetition: An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component. | 16 |
| Relaxation/Health Education A relaxation intervention used previously as a comparator intervention will be delivered by a health educator.
Veteran Calm: A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| End of 12-week Intervention | Lost to Follow-up | 3 | 4 |
| End of 12-week Intervention | Withdrawal by Subject | 0 | 2 |
| Final Assessment at 18 Weeks. | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Yoga and Mantram Repetition | Total | Relaxation/Health Education |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 14.6 | 47.1 years STANDARD_DEVIATION 14.6 | 39.6 years STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 15 Participants | 6 Participants |
| Region of Enrollment United States | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 28 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 3 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Roland-Morris Disability Questionnaire (RMDQ)
The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Time frame: Change between baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | Roland-Morris Disability Questionnaire (RMDQ) | 13.6 score on a scale | Standard Deviation 4.4 |
| Relaxation/Health Education | Roland-Morris Disability Questionnaire (RMDQ) | 14.3 score on a scale | Standard Deviation 6.6 |
Secondary
AUDIT-C
AUDIT-C is a 3-item screen for problem drinking and will refer to alcohol use over the past 3-month period. The measure has questions on typical consumption and binge drinking frequency. Each question is rated on a scale from 0-4 and the total score ranges from 0-12 with higher scores indicating a greater likelihood of alcohol use problems.
Time frame: Change between baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | AUDIT-C | -0.62 score on a scale | Standard Deviation 0.87 |
| Relaxation/Health Education | AUDIT-C | -0.10 score on a scale | Standard Deviation 0.57 |
Secondary
BPI Pain Interference
Brief Pain Inventory Pain Interference - The total score is the mean of the 7 pain interference items. Scores range from 0-10 with higher scores indicating greater pain interference.
Time frame: change from baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | BPI Pain Interference | -0.73 score on a scale | Standard Deviation 2.28 |
| Relaxation/Health Education | BPI Pain Interference | -0.46 score on a scale | Standard Deviation 2.24 |
Secondary
BPI Pain Severity
Brief Pain Inventory Pain Severity - The total score is the mean of the 4 pain severity items. Scores range from 0-10 with higher scores indicating greater pain severity.
Time frame: change from baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | BPI Pain Severity | -0.15 score on a scale | Standard Deviation 1.71 |
| Relaxation/Health Education | BPI Pain Severity | -1.15 score on a scale | Standard Deviation 1.78 |
Secondary
Fatigue
Fatigue Severity Scale - The scale consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63. Higher scores reflect greater fatigue severity and less energy.
Time frame: change from baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | Fatigue | -7.38 score on a scale | Standard Deviation 9.38 |
| Relaxation/Health Education | Fatigue | -4.90 score on a scale | Standard Deviation 8.16 |
Secondary
Insomnia Severity Index (ISI)
Insomnia Severity Index is a 7-item instrument that assesses the impact of insomnia. Each question is rated on a scale from 0-4 and the total score ranges from 0-28 with higher scores indicating a greater severity of insomnia.
Time frame: Change between baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | Insomnia Severity Index (ISI) | -2.69 score on a scale | Standard Deviation 7.18 |
| Relaxation/Health Education | Insomnia Severity Index (ISI) | -0.30 score on a scale | Standard Deviation 3.92 |
Secondary
Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5)
The PCL-5 is a 20-item self-report measure assessing 20 DSM-5 symptoms of PTSD. Each question is rated on a scale from 0-4 and the total score ranges from 0-80 with higher scores indicating a greater severity of PTSD symptoms.
Time frame: Change between baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5) | -4.23 score on a scale | Standard Deviation 13.8 |
| Relaxation/Health Education | Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5) | -9.80 score on a scale | Standard Deviation 12.6 |
Secondary
Quality of Life - EQ5D
Health-related Quality of Life will be measured with the EQ5D-3L. Scores range from 0 to 1.0 with higher scores indicating better quality of life.
Time frame: Change between baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Yoga and Mantram Repetition | Quality of Life - EQ5D | 0.02 units on a scale | Standard Deviation 0.22 |
| Relaxation/Health Education | Quality of Life - EQ5D | 0.10 units on a scale | Standard Deviation 0.28 |