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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Insomnia, Secondary
• Intervention / Treatment: Behavioral: written exposure therapy; Behavioral: Written Exposure Therapy plus Mindfulness-Based App (WET + MBA); Behavioral: Minimal Contact Control (MCC)

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinyin Zang, PhD; Phone Number: 15553201610; Email: yinyin.zang@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100871
      • Recruiting
      • Peking University
      • Principal Investigator: Yinyin Zang, PhD
      • Contact: Yinyin Zang, PhD; Phone Number: 00861062756953; Email: yinyin.zang@pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written Exposure Therapy (WET)	Behavioral: written exposure therapy; 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.
Experimental: Written Exposure Therapy plus mindfulness-based App (WET+MBA)	Behavioral: Written Exposure Therapy plus Mindfulness-Based App (WET + MBA); 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.
Placebo Comparator: Minimal Contact Control (MCC)	Behavioral: Minimal Contact Control (MCC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptom severity	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).	Assessed at baseline, immediately post-treatment, and at 3-month follow-up periods.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	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.	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.

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: WET-PTSD-CN-PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No