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

York University

Status: Completed

Conditions: PTSD; Posttraumatic Stress Disorders

Treatments: Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03684473

2018-208

Details and patient eligibility

About

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.

Full 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 several co-morbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as the determination of appropriate treatment. 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 deliveries 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 trauma during pre-adult development. 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. This study evaluates such an intervention in terms of 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 results will demonstrate clinically significant reductions of: 1) PTSD total symptom severity; 2) statistically significant reductions in pupil dilation and; 3) significant increases in HRV at post-intervention. This is the first study to examine objective markers of autonomic regulation in an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) that compare 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 are made

Enrollment: 25 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Exposure to 1+ Lifetime Traumatic Events (LEC-5)
• Met clinical PTSD criteria and a minimum PTSD score of ≥ 12 on the Clinician Administered Posttraumatic Stress Scale (CAPS-5)
• 18-34 years of age

Exclusion criteria

• current/ongoing trauma (e.g., current physical or sexual abuse) within the last month
• current unstable medical condition
• current active suicide risk/self-harm and/or drug addiction
• current pregnancy/breastfeeding
• current yoga attendance within the last month
• no access to the internet

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Yoga Intervention

Experimental group

Description:

Participants in the intervention condition will be assigned to an 8-week online delivered trauma-informed yoga protocol focused on home-based daily practice of yoga and mindfulness meditation.

Treatment:

Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention