Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05421494
Status:
RECRUITING
Last Update Posted:
2022-07-14
First Post:
2022-06-09
Brief Title:
The Effectiveness of Written Exposure Therapy for PTSD
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
The Effectiveness of Online Revised Written Exposure Therapy for PTSD Randomized Controlled Trials
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
RECRUITING
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:
Study 1 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
45 participants will be allocated to MCC WET and WETMBA on a 111 ratio 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
Study 2 The study aims to examine the effectiveness of the online revised written exposure therapy WET-R for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial The study will recruit 90 participants with 60 randomized to the online WET-R group and 30 randomized to the minimal contact control MCC group The WET-R intervention consists of 5-7 one to one sessions The primary outcome PTSD Symptom Scale - Interview for DSM-5 PSSI-5 will be administered on baseline post-treatment 1-month follow-up 3-month follow-up and 6-month follow-up assessments
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
45 participants will be allocated to MCC WET and WETMBA on a 111 ratio 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
Study 2 The study aims to examine the effectiveness of the online revised written exposure therapy WET-R for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial The study will recruit 90 participants with 60 randomized to the online WET-R group and 30 randomized to the minimal contact control MCC group The WET-R intervention consists of 5-7 one to one sessions The primary outcome PTSD Symptom Scale - Interview for DSM-5 PSSI-5 will be administered on baseline post-treatment 1-month follow-up 3-month follow-up and 6-month follow-up assessments
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