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A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial.

Megan A Kirk, Bilal Taha, Kevin Dang, Hugh McCague, Dimitrios Hatzinakos, Joel Katz, Paul Ritvo

JMIR Mental Health February 28, 2022 DOI: 10.2196/26479 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Single-arm experimental clinical trial Randomized Cross-sectional Peer reviewed
Sample size 22
Population Adults aged 18-35 years reporting PTSD symptoms
Interventions Web-based cognitive behavioral therapy mindfulness and yoga (CBT-MY) web-based counseling
Duration 8-week intervention
Measures Peak pupil dilation (PPD), heart rate variability (HRV)
Topics Meditation PTSD
Keywords Cognitive behavioral therapy Cognitive therapy Internet delivery Intervention Posttraumatic stress disorder Psychophysiology Pupillometry
Registration NCT03684473
Key findings Web-based CBT-MY was associated with large pre-post reductions in PTSD severity (d=1.60), depression (d=0.83), anxiety (d=0.99), and mindfulness (d=0.88), and a significant reduction in peak pupil dilation (d=0.90) but no significant change in heart rate variability. The authors suggest these gains indicate clinically significant symptom improvement and healthier autonomic functioning, while noting that randomized controlled trials are needed.

Abstract

Posttraumatic stress disorder (PTSD) is a debilitating, undertreated condition. The web-based delivery of cognitive behavioral therapy supplemented with mindfulness meditation and yoga is a viable treatment that emphasizes self-directed daily practice. This study aims to examine the effectiveness of a web-based cognitive behavioral therapy, mindfulness, and yoga (CBT-MY) program designed for daily use. We conducted an 8-week, single-arm, experimental, registered clinical trial on adults reporting PTSD symptoms (n=22; aged 18-35 years). Each participant received web-based CBT-MY content and an hour of web-based counseling each week. Pre-post outcomes included self-reported PTSD symptom severity, depression, anxiety, chronic pain, and mindfulness. Pre-post psychophysiological outcomes included peak pupil dilation (PPD) and heart rate variability (HRV). HRV and PPD were also compared with cross-sectional data from a non-PTSD comparison group without a history of clinical mental health diagnoses and CBT-MY exposure (n=46). Pre-post intention-to-treat analyses revealed substantial improvements in PTSD severity (d=1.60), depression (d=0.83), anxiety (d=0.99), and mindfulness (d=0.88). Linear multilevel mixed models demonstrated a significant pre-post reduction in PPD (B=-0.06; SE=0.01; P<.001; d=0.90) but no significant pre-post change in HRV (P=.87). Overall, participants spent an average of 11.53 (SD 22.76) min/day on self-directed mindfulness practice. Web-based CBT-MY was associated with clinically significant symptom reductions and significant PPD changes, suggesting healthier autonomic functioning. Future randomized controlled trials are needed to further examine the gains apparent in this single-arm study. ClinicalTrials.gov NCT03684473; https://clinicaltrials.gov/ct2/show/NCT03684473.

Comparable studies

Other non-randomized and open-label trials on PTSD, most cited first.

Study Year Design Participants
Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Adults with chronic, treatment-resistant PTSD 2013 Long-term follow-up of a completed trial n = 19
Loving‐Kindness Meditation for Posttraumatic Stress Disorder: A Pilot Study Veterans with posttraumatic stress disorder (PTSD) 2013 Open pilot trial
Effects of Transcendental Meditation in Veterans of Operation Enduring Freedom and Operation Iraqi Freedom With Posttraumatic Stress Disorder: A Pilot Study Veterans from Operation Enduring Freedom or Operation Iraqi Freedom with combat-related... 2011 Uncontrolled pilot study n = 5
MDMA-facilitated cognitive-behavioural conjoint therapy for posttraumatic stress disorder: an uncontrolled trial. Couples in which one partner was diagnosed with PTSD 2020 Pilot study n = 6
Culturally informed research design issues in a study for MDMA-assisted psychotherapy for posttraumatic stress disorder People of color with posttraumatic stress disorder 2019 Phase 2 open-label multisite study

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