Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study
- Conditions
- PTSDInsomnia, Secondary
- Interventions
- Behavioral: written exposure therapyBehavioral: Minimal Contact Control (MCC)Behavioral: Written Exposure Therapy plus Mindfulness-Based App (WET + MBA)
- Registration Number
- NCT06394700
- Lead Sponsor
- Peking University
- Brief Summary
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?
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.
Participants will:
* Undergo random assignment to one of three groups: WET, WET plus MBA, or MCC.
* Receive clinical interviews for primary outcomes (PTSD symptoms) at baseline, posttreatment, and during follow-ups.
* Provide self-reported data on PTSD symptoms and insomnia severity at multiple time points.
* In the WET plus MBA group, additionally use a mindfulness-based app as part of their treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Written Exposure Therapy (WET) written exposure therapy - Minimal Contact Control (MCC) Minimal Contact Control (MCC) - Written Exposure Therapy plus mindfulness-based App (WET+MBA) Written Exposure Therapy plus Mindfulness-Based App (WET + MBA) -
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Insomnia Severity Insomnia severity is assessed at baseline, weekly during the 5-week treatment period, and at the immediate post-treatment, and 3-month follow-up assessments. The reduction in the severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by the sleep disturbance. Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity.
Trial Locations
- Locations (1)
Peking University
🇨🇳Beijing, Beijing, China