The Effectiveness of Written Exposure Therapy for PTSD

Condition(s) studied

Investigational drug(s) / intervention(s)

written exposure therapy-revised version: WET-R is a manualized exposure-based therapy program consisting of 5-7 sequential individual sessions. The interval between every 2 consecutive sessions is 0-3 days. There will be 5-7 one to one online sessions in total (only one index trauma will be discussed), and 1-3 weeks to complete. Sessions are scheduled to last for 1 hour in the first session and 50 minutes in other sessions.

minimal contact control: Participants assigned to MCC will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the 3-week MCC period. They will be video-called once per week by a therapist to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MCC participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Study summary

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.

Eligibility

Primary outcome measure(s)

• study 2: Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at Posttreatment — 3 weeks
  The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).
• study 2: Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the First Follow-Up — 7 weeks
  The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).
• study 2: Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Second Follow-Up — 15 weeks
  The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).
• study 2: Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Third Follow-Up — 27 weeks
  The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).
• study 1: PTSD symptom severity — Assessed at baseline, immediately post-treatment, and at 3-month follow-up periods.
  The reduction in PTSD symptoms will be measured using the PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5). This clinician-administered interview assesses the frequency and severity of PTSD symptoms using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

Trial sites (1)

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