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

NCT ID: NCT06394700

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2024-08-31

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.

Conditions

PTSD; Insomnia, Secondary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Written Exposure Therapy (WET)

Group Type: EXPERIMENTAL

written exposure therapy

Intervention Type: 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 plus mindfulness-based App (WET+MBA)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Minimal Contact Control (MCC)

Group Type: PLACEBO_COMPARATOR

Minimal Contact Control (MCC)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yinyin Zang, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yinyin Zang, PhD

Role: CONTACT

yinyin.zang@pku.edu.cn

15553201610

Facility Contacts

Yinyin Zang, PhD

Role: primary

yinyin.zang@pku.edu.cn

00861062756953

Other Identifiers

WET-PTSD-CN-PILOT

Identifier Type: -

Identifier Source: org_study_id