Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05421494
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05421494
Study Brief:
Protocol Section:
NCT05421494