Evaluating Written Exposure Therapy for PTSD
The Effectiveness of Online Revised Written Exposure Therapy for PTSD: Randomized Controlled Trials
This study is testing if Written Exposure Therapy alone or with a mindfulness app can help Chinese adults with PTSD and insomnia feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05421494 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and comorbid insomnia among Chinese adults. Participants will be randomly assigned to receive either WET alone, minimal contact control, or WET combined with MBA. The study will compare the outcomes of these interventions to determine if WET is effective in reducing PTSD symptoms and if the addition of MBA enhances the management of insomnia. A total of 135 participants will be recruited for this pilot randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a diagnosis of PTSD or subthreshold PTSD and comorbid insomnia.
Not a fit: Patients with bipolar disorder, psychotic disorders, or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective online intervention for managing PTSD and insomnia, improving the quality of life for affected individuals.
How similar studies have performed: Previous studies have shown promise in using written exposure therapy for PTSD, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Study 1: Inclusion Criteria: 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). Exclusion Criteria: A diagnosis of bipolar disorder or psychotic disorder; Current substance dependence; Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the baseline screening questionnaires); Serious suicidal ideation (as determined by the Scale for Suicidal Ideation); Other psychiatric disorders severe enough to warrant designation as the primary disorder; Taking psychotherapy for PTSD currently. Study 2: Inclusion Criteria: 1. Adult male and female (aged between 18-65 years old) 2. A diagnosis of PTSD or subclinical PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5), meeting the following criteria: Meeting full criteria for re-experiencing and at least 2 of 3 other symptom clusters (i.e., avoidance, negative cognitions, or hyperarousal) 3. If currently taking psychotropic medication, taking a stable one for at least 4 weeks 4. Having the ability to write and comprehend the writing guidelines Exclusion Criteria: 1. A diagnosis of bipolar disorder or psychotic disorder 2. Current substance dependence 3. Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the screening questionnaires) 4. Serious suicidal ideation (as determined by the MINI interview) 5. Taking psychotherapy for PTSD currently
Where this trial is running
Beijing, Beijing Municipality
- Peking University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yinyin Zang, PhD
- Email: yinyin.zang@pku.edu.cn
- Phone: +86 15553201610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.