CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Yoga and Mantram Repetition +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03816007
NCT03816007N/ACompleted

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

VA Office of Research and Development·interventional·Posted Jan 25, 2019·Updated Oct 31, 2023

In Brief

A clinical study evaluating Yoga and Mantram Repetition and Veteran Calm for Post-Traumatic Stress Disorder and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartApr 1, 2021
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.4 years ago

Interventions

Yoga and Mantram Repetitionbehavioral

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 Calmbehavioral

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.