Yoga and Mantram for Chronic Pain and PTSD

Chronic Low Back Pain Clinical Trial

Official title:

An Enhanced Mind-body Intervention to Reduce Disability and Pain in Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816007
• Other study ID #: D3009-P
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Chronic Neck Pain
• Low Back Pain
• Neck Pain
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Change between baseline and 12-weeks
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.	change from baseline to 12 weeks
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.	Change between baseline and 12-weeks
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.	change from baseline to 12 weeks
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.	Change between baseline and 12-weeks
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.	Change between baseline and 12-weeks
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.	Change between baseline and 12-weeks
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.	change from baseline to 12 weeks