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Written exposure therapy and app-delivered mindfulness-based meditation for PTSD and subthreshold PTSD in China: Design of a randomized controlled trial.

Muyang Li, Bingsu Wang, Qiang Chen, Danlong Gao, Yinyin Zang

Contemporary Clinical Trials Communications June 2021 DOI: 10.1016/j.conctc.2021.100729 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial protocol Peer reviewed
Sample size 150
Population Chinese adults with subthreshold or full PTSD and comorbid insomnia
Interventions Written exposure therapy mindfulness-based application
Duration 5-session treatment; assessments at baseline, posttreatment, 3- and 6-month follow-up
Topics Meditation PTSD
Keywords Chinese Gq-5, gratitude questionnaire-5 Hpa-axis, hypothalamic–pituitary–adrenal axis Mba, mindfulness-based application Mlms, multilevel models Mm, mindfulness-based meditation Pcl-5, PTSD Checklist-Dsm5 Pe, prolonged exposure Pssi-5, PTSD Ptg, posttraumatic growth Written exposure therapy App, application Mhealth
Key findings The protocol proposes testing whether written exposure therapy reduces PTSD symptoms in Chinese patients and whether adding a mindfulness-based mobile application to written exposure therapy reduces comorbid insomnia, compared with written exposure therapy alone and a minimal contact control. No outcome results are reported; the authors state this is the first application of written exposure therapy in a Chinese PTSD population.

Abstract

Posttraumatic stress disorder (PTSD) and subthreshold PTSD are still major global concerns, especially in developing areas short of mental health resources. Written exposure therapy (WET), a brief 5-session treatment, has been found to be effective in reducing PTSD symptoms, but no studies have examined it in an Eastern context. Mindfulness-based meditation mobile application may be a promising approach to reduce insomnia comorbid with PTSD. The current study aims to: 1) examine the effectiveness of WET for Chinese PTSD and subthreshold PTSD patients, and 2) examine the effectiveness of adding a mindfulness-based application (MBA) to WET for reducing comorbid insomnia. The randomized controlled trial will enroll 150 adults with subthreshold/full PTSD and comorbid insomnia. Participants will be randomly assigned to written exposure therapy plus mindfulness-based application condition (WET + MBA, n = 50), written exposure therapy alone (WET, n = 50), or minimal contact control (MMC, n = 50). Clinical interview of the primary outcome (PTSD symptoms) will be administrated at baseline, posttreatment, 3- and 6- month follow-up, while self-reported PTSD symptoms and secondary outcomes (insomnia severity) will be administrated at baseline, every week and all follow-ups. This is the first study applying WET in Chinese PTSD patients, as well as examining a mindfulness-based mobile application as a treatment add-on for comorbid insomnia. Study findings will contribute to the knowledge of the effectiveness of WET and a mindfulness-based mobile application, and the development of a culture-adapted treatment protocol. ChiCTR, ChiCTR2000034119. Registered 24 June 2020, http://www.chictr.org.cn/showproj.aspx?proj=55,467.

Comparable studies

Other randomized controlled trials on PTSD, most cited first.

Study Year Design Participants
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Patients with severe PTSD, including those with comorbidities such as dissociation,... 2021 Randomized controlled trial n = 90
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Patients with chronic post-traumatic stress disorder refractory to both psychotherapy... 2010 Randomized controlled trial n = 20
Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures 2014 Randomized controlled trial n = 41
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Military veterans and first responders aged 18 or older with chronic PTSD lasting 6... 2018 Randomized, double-blind, dose-response, phase 2 clinical trial n = 26
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Patients with treatment-resistant PTSD 2012 Randomized controlled trial n = 12

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