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 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00211835
Eligibility Criteria:
Inclusion Criteria:
* Being at least 18years old
* Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
* Being at least 6 months post injury
* Being English-speaking
* Having residential telephone service
* Living within 1.5 hours of New York City
* Having at least a sixth-grade reading level
* Meeting DSM-IV criteria for a current depressive mood disorder
* Not being in psychotherapy and being willing to abstain from seeking psychotherapy during the course of participation
* Being willing to complete questionnaires and interviews about mood, thinking skills, community participation and life satisfaction
* Agreeing to participate, verified by completion of informed consent and HIPAA documents.
* Individuals who meet criteria and are currently using prescribed mood medications will be included in the study if dosage has been stable for sixty days.
Exclusion Criteria:
* Pre-existing neurological disorder, including brain injury from an etiology other than trauma
* History of mental retardation
* Lack of capacity to sign informed consent
* Taking antidepressant medications for less than six months
* Having any changes in antidepressant medications in the last six months
* History of current or past psychosis or mania
* Current substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00211835
Study Brief:
Protocol Section:
NCT00211835