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

NCT03684473 | Completed

• 1 other identifier: 2018-208
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorders; PTSD

Keywords

Yoga; Mindfulness Meditation; Online; Posttraumatic Stress Disorder; Young Adulthood

Outcome Measures

Primary Outcomes (1)

• Change in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5)

  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.

  Baseline and 8-weeks

Secondary Outcomes (3)

• Change in Heart Rate Variability

  Baseline and 8-weeks

• Change in Pupil Diameter

  Baseline and 8-weeks

• Change in Respiration Rate

  Baseline and 8-weeks

Other Outcomes (6)

• Change in Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - Civilian Version (PCL-5)

  Baseline and 8-weeks

• Change in Beck Anxiety Inventory (BAI)

  Baseline and 8-weeks

• Change in Beck Depression Index-II (BDI-II)

  Baseline and 8-weeks

Study Arms (1)

Yoga Intervention

EXPERIMENTAL

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.

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

Interventions

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

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.

Also known as: Online Trauma-Informed Mindfulness-Based CBT Intervention

Yoga Intervention

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (1)

• Kirk MA, Taha B, Dang K, McCague H, Hatzinakos D, Katz J, Ritvo P. A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. JMIR Ment Health. 2022 Feb 28;9(2):e26479. doi: 10.2196/26479.

  PMID: 34499613 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Paul Ritvo, PhD

  York University, Toronto, Ontario, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Clinical Psychologist

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: September 25, 2018
• Study Start: October 31, 2018
• Primary Completion: February 15, 2020
• Study Completion: March 31, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)