An Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress Disorder
NCT03684473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2022-02-08
Summary
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.
Conditions
- Posttraumatic Stress Disorders
- PTSD
Interventions
- BEHAVIORAL
-
Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention
8 Weekly Online modules consisting of one weekly video of yoga postures combined with breath awareness and daily guided meditation audios, and a breath technique manual form the foundation of the intervention. The trauma-informed component of the program uses specific language, movement cues, teacher qualities, and physical assists. The yoga intervention will emphasize full choice and control of the participant through invitational language such as, "when you are ready", "if you like" before each body posture cue. Based on trauma-informed yoga best practices, a predictable foundation of yoga postures (with variations) will be followed in a consistent order each session to allow participants to anchor to the series.
Sponsors & Collaborators
-
York University
lead OTHER
Principal Investigators
-
Paul Ritvo, PhD · York University, Toronto, Ontario, Canada
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 34 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-31
- Primary Completion
- 2020-02-15
- Completion
- 2021-03-31
Countries
- Canada
Study Locations
More Related Trials
-
Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)
NCT01556074 ·Status: COMPLETED ·Phase: NA
-
Motivational Interviewing and Cognitive Behavioural Therapy for Generalized Anxiety Disorder
NCT01488799 ·Status: COMPLETED ·Phase: NA
-
SKY vs. HEP in PTSD
NCT03534583 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of Telehealth Interventions for Post-Trauma Stress
NCT00350584 ·Status: COMPLETED ·Phase: NA
-
Feasibility of a Yoga Program for Veterans With PTSD
NCT05177757 ·Status: COMPLETED ·Phase: NA
-
Implementation of Evidence-based Psychotherapy for PTSD
NCT01861769 ·Status: COMPLETED ·Phase: NA
-
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
NCT01035788 ·Status: COMPLETED ·Phase: NA
-
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
NCT03874793 ·Status: COMPLETED ·Phase: NA
-
Sustaining and Improving Clinicians' Use of Evidence-Based Psychotherapy (EBP) for PTSD
NCT02449421 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Impact of Cognitive Behavioral Therapy on PTSD-CVD Link
NCT06429293 ·Status: RECRUITING ·Phase: NA
-
Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women
NCT04605198 ·Status: COMPLETED ·Phase: NA
-
Individual PE vs Couples' CBT for Combat-Related Posttraumatic Stress Disorder
NCT02336971 ·Status: COMPLETED ·Phase: PHASE3
-
Yoga Based Psychotherapy Group Feasibility and Efficacy Study
NCT01524172 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women With Post-Traumatic Stress Disorder
NCT06669442 ·Status: COMPLETED ·Phase: NA
-
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
NCT01521442 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder
NCT00962403 ·Status: COMPLETED ·Phase: NA
-
Yoga and Mantram for Chronic Pain and PTSD
NCT03816007 ·Status: COMPLETED ·Phase: NA
-
Cognitive-behavioral Therapy for Treatment of Post-traumatic Stress Disorder and Related Problems
NCT03019497 ·Status: COMPLETED ·Phase: NA
-
Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel
NCT04335487 ·Status: RECRUITING ·Phase: NA
-
Online and Mobile Mindfulness Intervention to Reduce Distress
NCT04035304 ·Status: UNKNOWN ·Phase: NA
-
Early Prevention of Post Traumatic Stress Disorder
NCT02004743 ·Status: COMPLETED ·Phase: NA
-
Combined Ketamine and eCBT Intervention for PTSD
NCT04771767 ·Status: UNKNOWN ·Phase: PHASE2
-
Yoga and Physical Activity for Veterans
NCT03509909 ·Status: COMPLETED ·Phase: NA
-
Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
NCT05938816 ·Status: TERMINATED ·Phase: NA
-
Guided Internet-based Trauma-focused CBT Programme for Post-traumatic Stress Disorder 'Spring'
NCT06475716 ·Status: NOT_YET_RECRUITING ·Phase: NA