๐ฌIn plain words
What the trial is, and whether it could suit you
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 WET+MBA on a 1:1:1 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 PTS
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Study 1:
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Study 2:
Inclusion Criteria:
1. Adult male and female (aged between 18-65 years old)
2. A diagnosis of PTSD or subclinical PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5), meeting the following criteria: Meeting full criteria for re-experiencing and at least 2 of 3 other symptom clusters (i.e., avoidance, negative cognitions, or hyperarousal)
3. If currently taking psychotropic medication, taking a stable one for at least 4 weeks
4. Having the ability to write and comprehend the writing guidelines
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 screening questionnaires)
4. Serious suicidal ideation (as determined by the MINI interview)
5. Taking psychotherapy for PTSD currently
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What it tests
- written exposure therapy-revised version
- minimal contact control
Peking University
Beijing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.