NCT06394700

Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study

Written Exposure Therapy and App-Delivered Mindfulness-Based Meditation for PTSD and Subthreshold PTSD in China: A Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to use a pilot RCT to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and comorbid insomnia in China. The main questions it aims to answer are: 1. Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD? 2. Does the addition of MBA to WET lead to greater reductions in comorbid insomnia symptoms compared to WET alone? Researchers will compare WET alone and MCC to see if WET provides benefits in managing PTSD. Researchers will compare WET plus MBA and WET group to see if the integrated MBA treatment provides additional benefits in managing insomnia. Participants will: * Undergo random assignment to one of three groups: WET, WET plus MBA, or MCC. * Receive clinical interviews for primary outcomes (PTSD symptoms) at baseline, posttreatment, and during follow-ups. * Provide self-reported data on PTSD symptoms and insomnia severity at multiple time points. * In the WET plus MBA group, additionally use a mindfulness-based app as part of their treatment.

Conditions

• PTSD
• Insomnia, Secondary

Interventions

Type	Name	Description
BEHAVIORAL	written exposure therapy	Written Exposure Therapy (WET) is a manualized exposure-based therapy involving five sequential weekly individual sessions. Each session lasts approximately 40 minutes except the first, which is one hour. In the initial session, the therapist explains the treatment rationale and guides the participant to write about their traumatic experience uninterrupted for 30 minutes. Subsequent sessions start with a brief discussion about the previous session's writing, followed by another 30-minute writing session, concluding with a short check-in. There is no homework between sessions.
BEHAVIORAL	Written Exposure Therapy plus Mindfulness-Based App (WET + MBA)	WET + MBA combines the standard WET protocol with the addition of a mindfulness practice facilitated through a mobile app called "Now Meditation." This app is among the most downloaded mindfulness apps in China, used to help manage symptoms of insomnia commonly comorbid with PTSD. Participants are instructed to engage in daily mindfulness exercises according to the app's "7-Day Basic Meditation" program and continue practicing mindfulness throughout the duration of the therapy. This is intended to supplement the therapeutic effects of WET by providing tools to manage insomnia and potentially enhancing the therapeutic process by fostering greater mindfulness and relaxation.
BEHAVIORAL	Minimal Contact Control (MCC)	MCC contains weekly phone calls from a study therapist to monitor their status and provide support as needed, without introducing any specific therapeutic interventions. These calls are brief, generally lasting between 10 to 15 minutes, and are strictly for the purpose of engagement and safety monitoring rather than therapeutic intervention.

Timeline

• Start date: 2021-11-11
• Primary completion: 2024-05-01
• Completion: 2024-08-01
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: China