Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study
Written Exposure Therapy and App-Delivered Mindfulness-Based Meditation for PTSD and Subthreshold PTSD in China: A Pilot Randomized Controlled Trial
Peking University
45 participants
Nov 11, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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.
Interventions
Written Exposure Therapy (WET) is a manualized exposure-based therapy involving five sequential weekly individual sessions. Each session lasts approximately 40 minutes except the first, which is one hour. In the initial session, the therapist explains the treatment rationale and guides the participant to write about their traumatic experience uninterrupted for 30 minutes. Subsequent sessions start with a brief discussion about the previous session's writing, followed by another 30-minute writing session, concluding with a short check-in. There is no homework between sessions.
WET + MBA combines the standard WET protocol with the addition of a mindfulness practice facilitated through a mobile app called "Now Meditation." This app is among the most downloaded mindfulness apps in China, used to help manage symptoms of insomnia commonly comorbid with PTSD. Participants are instructed to engage in daily mindfulness exercises according to the app's "7-Day Basic Meditation" program and continue practicing mindfulness throughout the duration of the therapy. This is intended to supplement the therapeutic effects of WET by providing tools to manage insomnia and potentially enhancing the therapeutic process by fostering greater mindfulness and relaxation.
MCC contains weekly phone calls from a study therapist to monitor their status and provide support as needed, without introducing any specific therapeutic interventions. These calls are brief, generally lasting between 10 to 15 minutes, and are strictly for the purpose of engagement and safety monitoring rather than therapeutic intervention.
Locations(1)
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NCT06394700