NCT03684473

An Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress Disorder

Completed NA Last updated 8 February 2022

What this trial tests

NA trial testing Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention in Posttraumatic Stress Disorders in 25 participants. Completed in 31 March 2021.

Timeline

31 October 2018

Primary endpoint
15 February 2020

31 March 2021

Quick facts

Lead sponsor	York University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	31 October 2018
Primary completion	15 February 2020
Estimated completion	31 March 2021
Sites	1 location across Canada

Drugs / interventions tested

• Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention

Conditions studied

• Posttraumatic Stress Disorders — all drugs for Posttraumatic Stress Disorders →
• PTSD — all drugs for PTSD →

Sponsor

York University

Who can join

Adults 18 to 34, any sex, with Posttraumatic Stress Disorders or PTSD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with other comorbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as selection of the appropriate treatment approach. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment delivery for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced childhood trauma. No known clinical trial (CT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective psychophysiology measures. The purpose of this study is to evaluate changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week single-arm experimental design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity by 10% and 2) significant reductions in pupil dilation at post-intervention and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation among an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) and comparing two theoretically-linked measures (e.g., HRV, Pupillometry). Comparisons of psychophysiology data with a cross-sectional convenience sample with no history of clinical PTSD or mental health conditions were made.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial.
   Kirk MA, Taha B, Dang K, McCague H, et al · · 2022 · cited 8× · PMID 34499613 · DOI 10.2196/26479