Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study

NCT06394700 | Recruiting

• 1 other identifier: WET-PTSD-CN-PILOT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

PTSD; Insomnia, Secondary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Written Exposure Therapy (WET)

EXPERIMENTAL

Behavioral: written exposure therapy

Written Exposure Therapy plus mindfulness-based App (WET+MBA)

EXPERIMENTAL

Behavioral: Written Exposure Therapy plus Mindfulness-Based App (WET + MBA)

Minimal Contact Control (MCC)

PLACEBO COMPARATOR

Behavioral: Minimal Contact Control (MCC)

Interventions

written exposure therapy BEHAVIORAL

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.

Written Exposure Therapy (WET)

Written Exposure Therapy plus Mindfulness-Based App (WET + MBA) BEHAVIORAL

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.

Written Exposure Therapy plus mindfulness-based App (WET+MBA)

Minimal Contact Control (MCC) BEHAVIORAL

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.

Minimal Contact Control (MCC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Wettability

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydrophobic and Hydrophilic Interactions; Chemical Phenomena; Surface Properties

Central Study Contacts

Yinyin Zang, PhD

CONTACT

15553201610; yinyin.zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 1, 2024
• Study Start: November 11, 2021
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)