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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adult male and female aged between 18-65 years old;

• A diagnosis of PTSD or subthreshold PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5);

• If currently taking psychotropic medication, taking a stable one for at least 4 weeks;

• A smartphone owner and no obstacle to the Now Meditation App;

• Scoring 12 or more on Insomnia Severity Index (ISI; the symptoms appear after the diagnosis of full/subthreshold PTSD).

Locations
Other Locations
China
Peking University
RECRUITING
Beijing
Contact Information
Primary
Yinyin Zang, PhD
yinyin.zang@pku.edu.cn
15553201610
Time Frame
Start Date: 2021-11-11
Estimated Completion Date: 2024-08
Participants
Target number of participants: 45
Treatments
Experimental: Written Exposure Therapy (WET)
Experimental: Written Exposure Therapy plus mindfulness-based App (WET+MBA)
Placebo_comparator: Minimal Contact Control (MCC)
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov