PTSDNCT06394700
Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China: A Pilot Study
A study testing written exposure therapy and Written Exposure Therapy plus Mindfulness-Based App (WET + MBA) in people with PTSD and Insomnia, Secondary, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Insomnia, Secondary
- What is being tested?
- written exposure therapy and Written Exposure Therapy plus Mindfulness-Based App (WET + MBA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2021to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality, 100871
Yinyin Zang, PhD, 00861062756953, yinyin.zang@pku.edu.cn
Yinyin Zang, PhD
About this study
Official title: 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:
- Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD?
- Does the addition of MBA to WET lead to greater reductions in comorbid insomnia symptoms compared to WET alone?
Read more
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
- Being tested
- written exposure therapy, Written Exposure Therapy plus Mindfulness-Based App (WET + MBA), Minimal Contact Control (MCC)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written exposure therapyBehavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy (WET) | Experimental | Not described Receives: Behavioral: written exposure therapy |
| Written Exposure Therapy plus mindfulness-based App (WET+MBA) | Experimental | Not described Receives: Behavioral: Written Exposure Therapy plus Mindfulness-Based App (WET + MBA) |
| Minimal Contact Control (MCC) | Placebo comparator | Not described Receives: Behavioral: Minimal Contact Control (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed at baseline, immediately post-treatment, and at 3-month follow-up periods.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start11 Nov 2021
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394700
- Sponsor's protocol ID
- WET-PTSD-CN-PILOT
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Exposure Therapy and App-Delivered Mindfulness-Based Meditation for PTSD and Subthreshold PTSD in China: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06394700
- Acronym / sponsor ID
- WET-PTSD-CN-PILOT
- Conditions
- PTSD, Insomnia, Secondary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| written exposure therapyWritten 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. | Behavioural | Written Exposure Therapy (WET) |
| 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. | Behavioural | Written Exposure Therapy plus mindfulness-based App (WET+MBA) |
| 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. | Behavioural | Minimal Contact Control (MCC) |
Primary outcome
PTSD symptom severity
Time frame: 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).
1 secondary outcome
Insomnia Severity
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing written exposure therapy and Written Exposure Therapy plus Mindfulness-Based App (WET + MBA) in people with PTSD and Insomnia, Secondary, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yinyin Zang, PhD (15553201610, yinyin.zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity (time frame: Assessed at baseline, immediately post-treatment, and at 3-month follow-up periods.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.