NCT05421494

The Effectiveness of Written Exposure Therapy for PTSD

Recruiting now NA Last updated 16 October 2024

What this trial tests

NA trial testing written exposure therapy-revised version in PTSD in 135 participants. Currently enrolling.

Timeline

15 June 2022

Primary endpoint
10 June 2024

10 December 2024

Quick facts

Lead sponsor	Peking University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	135
Start date	15 June 2022
Primary completion	10 June 2024
Estimated completion	10 December 2024
Sites	1 location across China

Drugs / interventions tested

• written exposure therapy-revised version
• minimal contact control

Conditions studied

• PTSD — all drugs for PTSD →
• Subclinical PTSD — all drugs for Subclinical PTSD →

Sponsor

Peking University

Who can join

Adults 18 to 65, any sex, with PTSD or Subclinical PTSD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study 1: 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?

45 participants will be allocated to MCC, WET, and WET+MBA on a 1:1:1 ratio. 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.

Study 2: The study aims to examine the effectiveness of the online revised written exposure therapy (WET-R) for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial. The study will recruit 90 participants, with 60 randomized to the online WET-R group, and 30 randomized to the minimal contact control (MCC) group. The WET-R intervention consists of 5-7 one to one sessions. The primary outcome PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.