Using written therapy and a mindfulness app to treat PTSD in China
Written Exposure Therapy and App-Delivered Mindfulness-Based Meditation for PTSD and Subthreshold PTSD in China: A Pilot Randomized Controlled Trial
This study is testing whether combining written therapy with a mindfulness app can help Chinese adults with PTSD and insomnia feel better compared to just using the written therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06394700 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and insomnia among Chinese adults. Participants will be randomly assigned to one of three groups: WET alone, WET combined with the MBA, or a Minimal Contact Control (MCC) group. The study will assess changes in PTSD symptoms and insomnia severity through clinical interviews and self-reported data at various time points. The goal is to determine if the combination of WET and MBA offers greater benefits than WET alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of PTSD or subthreshold PTSD and insomnia.
Not a fit: Patients with bipolar disorder, psychotic disorders, or severe suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective, accessible treatment option for individuals suffering from PTSD and insomnia.
How similar studies have performed: While the combination of WET and mindfulness apps is a novel approach, similar interventions have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult male and female aged between 18-65 years old; 2. A diagnosis of PTSD or subthreshold PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5); 3. If currently taking psychotropic medication, taking a stable one for at least 4 weeks; 4. A smartphone owner and no obstacle to the Now Meditation App; 5. Scoring 12 or more on Insomnia Severity Index (ISI; the symptoms appear after the diagnosis of full/subthreshold PTSD). 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 baseline screening questionnaires); 4. Serious suicidal ideation (as determined by the Scale for Suicidal Ideation); 5. Other psychiatric disorders severe enough to warrant designation as the primary disorder; 6. Taking psychotherapy for PTSD currently.
Where this trial is running
Beijing, Beijing
- Peking University — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yinyin Zang, PhD
- Email: yinyin.zang@pku.edu.cn
- Phone: 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.