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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02658669
Eligibility Criteria:
Inclusion Criteria:
1. OEF/OIF/OND Veteran ages 18-55.
2. Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)
1. Loss of consciousness 30 minutes
2. Post-traumatic amnesia 1 day
3. At least 3 months post-TBI.
4. A diagnosis of insomnia classified as:
1. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria that include: trouble falling asleep, staying asleep, waking too early, and/or non-restorative sleep with accompanied daytime impairment in functioning for \> 3 months, occurring at least 3 nights per week.
2. Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score \>5 and Insomnia Severity Index score \>7 at intake.
5. No prior exposure to and/or treatment with CBT-I within the past 2 years.
6. Must be stable on medication regimen for at least 1 month prior to enrollment in study.
Exclusion Criteria:
1. History of a neurological disorder (besides TBI), dementia, or premorbid IQ \<70.
2. Schizophrenia, psychotic disorder, and/or bipolar disorder.
3. Evidence of suicidality more than "low risk" as determined by the VA Comprehensive Suicide Risk Assessment (CSRA).
4. Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements)
5. Alcohol and/or substance abuse within the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02658669
Study Brief:
Protocol Section:
NCT02658669