Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05421494

The Effectiveness of Written Exposure Therapy for PTSD

Led by Peking University · Updated on 2024-10-16

135

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effectiveness of Written Exposure Therapy for PTSD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosis of PTSD or subthreshold/subclinical PTSD using PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5)
  • If taking psychotropic medication, dose must be stable for at least 4 weeks
  • Ability to write and understand the writing guidelines (for Study 2)
  • Own a smartphone and have no obstacle to using the Now Meditation App (for Study 1)
  • Scoring 12 or more on the Insomnia Severity Index (for Study 1, symptoms appearing after PTSD diagnosis)
Not Eligible

You will not qualify if you...

  • Diagnosis of bipolar disorder or psychotic disorder
  • Current substance dependence
  • Evidence of moderate or severe traumatic brain injury affecting comprehension
  • Serious suicidal ideation as determined by clinical scales
  • Other severe psychiatric disorders that are primary
  • Currently receiving psychotherapy for PTSD

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Peking University

Beijing, Beijing Municipality, China, 100871

Actively Recruiting

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Research Team

Y

Yinyin Zang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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The Effectiveness of Written Exposure Therapy for PTSD | DecenTrialz