Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394700
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-23
Brief Title:
Written Exposure Therapy and App-Delivered Mindfulness Meditation for PTSD in China A Pilot Study
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Written Exposure Therapy and App-Delivered Mindfulness-Based Meditation for PTSD and Subthreshold PTSD in China A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None