An Online CBT, Mindfulness Meditation & Yoga (CBT-MY) Intervention for Posttraumatic Stress Disorder
- Conditions
- PTSDPosttraumatic Stress Disorders
- Interventions
- Behavioral: Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention
- Registration Number
- NCT03684473
- Lead Sponsor
- York University
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Yoga Intervention Online Mindfulness-Based CBT & Trauma-Informed Yoga Intervention 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.
- Primary Outcome Measures
Name Time Method Change in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) Baseline and 8-weeks A 30-item structured in-person interview with a trained clinician to confirm a current diagnosis of PTSD and associated symptoms based on a single index traumatic event (e.g., most recent, most severe). A single severity/distress score is calculated based on the frequency and intensity of a symptom using a 5-point scale (0 = absent/ no symptom; 1 = Mild/Symptom minimal; 2 = Moderate/Symptom Clearly Present; 3 = Severe/Symptom Pronounced; 4 = Extreme/Symptom is extreme/incapacitating). For a clinically significant symptom to be deemed present, a minimum frequency of twice per month or "some of the time" (approximately 20-30%) plus a minimum intensity of "clearly present" must be reported. Scores range from 0 to 80.
- Secondary Outcome Measures
Name Time Method Change in Respiration Rate Baseline and 8-weeks Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. A respiratory belt transducer will be worn around the abdomen at the same time heart rate and pupil diameter are being measured. The respiratory belt transducer is measures changes in chest diameter resulting from breathing by producing a linear voltage proportional to changes in length and connects directly to a Pod (DIN) Port on the electrocardiogram machine. Breaths will be measured and recorded as the number of breaths per minute.
Change in Pupil Diameter Baseline and 8-weeks Participants will wear specialised eye tracking glasses to obtain pupil dilation recordings. Accordingly, participants will be presented with a plain, neutral stimulus and asked to focus their eyes on a fixation cross on the computer. Baseline (BL) pupil diameter will be captured in the 500ms directly preceding the emotional stimulus. Participants will undergo an emotional stimulus (ES) task viewing standardized emotional images (e.g., happy, sad) on a computer screen followed by a guided 10-minute meditation (GM) phase. Average peak stimulus pupil dilation will be calculated during each phase (BL, ES, GM). Increased pupil dilation reflects sympathetic nervous system dominance.
Change in Heart Rate Variability Baseline and 8-weeks Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. Electrocardiogram (ECG) recordings will be collected using a 4-channel data acquisition system, which uses 2 adhesive electrodes applied to the chest and a ground electrode on the ankle. Frequency-based metrics represent respiratory-based modulation of the autonomic nervous system (ANS). The primary three spectral components for ECG recordings are very low frequency (VLF; 0.003-0.04 Hz), low frequency (LF; 0.04-0.15 Hz), and high frequency (HF; 0.15-0.4 Hz). Greater power in the HF band is considered to reflect respiratory sinus arrhythmia as it reflects HR variation attributed to parasympathetic (vagal) tone. Additionally, a ratio of LF to HF power will provide a marker of ANS regulation in all participants. A higher LF-HF ratio indicates "sympathetic dominance", whereas values closer to 0 reflect ANS balance.
Trial Locations
- Locations (1)
York University
🇨🇦Toronto, Ontario, Canada