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:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT03974503
Eligibility Criteria:
Inclusion Criteria:
* Be a Veteran enrolled to receive VA medical care at the Minneapolis VA Health Care System
* Have stable housing for the duration of the study period
* Have experienced any traumatic event meeting Criterion A for PTSD at least three months before the baseline assessment
* Meet criteria for a current PTSD diagnosis or subthreshold PTSD diagnosis
* Self-report experiencing trauma-related nightmares at least once per week for the past month, that are mostly-remembered and that cause awakening
* Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)
* Be stable on any psychoactive medications for a minimum of two weeks before the baseline assessment
Exclusion Criteria:
* Inability to provide fully-informed written consent to participate and/or a bed partner does not agree to mattress recording during the in-home portion of the study
* Medical conditions that limit ability to apply the treatment e.g., needing a health aide or caregiver to record sleep diaries, unable to get out of bed without assistance
* Current pregnancy and/or birth of a child within the previous 6 months
* Current alcohol or illicit substance use disorders or early remission (at least 3 months abstinent)
* Active suicidal or homicidal ideation
* A history of any bipolar disorder spectrum disorder or psychotic disorder
* Hospitalization for a mental health disorder in the past 2 months
* Enrolled in current PTSD-focused treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure), current nightmare treatment or a history of treatment failure with a cognitive-behavioral nightmare intervention
* Veterans may also be excluded from participation if they have been identified by the local VA disruptive behavior committee to have displayed disruptive, threatening and/or violent behavior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03974503
Study Brief:
Protocol Section:
NCT03974503