Phase
Condition
Post-traumatic Stress Disorders
Treatment
GAMBIT Task
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged 18-55 years
Participants must be able to provide informed consent
Participants must have a level of understanding of the English language sufficientto agree to all tests and examinations required by the study and must be able toparticipate fully in the informed consent process
Must meet criteria for one of the following study groups:
PTSD Group: i. Meets diagnostic criteria for current PTSD according to the Diagnostic andStatistical Manual of Mental Disorders-Fifth Edition (DSM-5)
- Has been exposed to a Criterion A trauma of the civilian type (e.g.,non-combat, threatened or actual interpersonal violence) or non-civilian
- Must have a total score ≥ 25 on the CAPS-5 (past-month version) at thetime of screening, indicating moderate PTSD symptom severity.
- Healthy Control Group: i. Has no lifetime history of any psychiatric disorder
Exclusion
Exclusion Criteria:
Current or lifetime history of schizophrenia or other psychotic disorder, bipolardisorder, obsessive-compulsive disorder (OCD), eating or feeding disorder,neurodevelopmental disorder, or neurocognitive disorder;
Any neuropsychiatric disorder that is judged to be the primary presenting problem,other than that which is specified as study group eligibility criteria;
Substance use disorder within the past 1 year;
Urine toxicology positive for illicit drugs or dis-allowed concomitant medicationsas per study protocol; intermittent cannabis use that does not meet criteria for asubstance use disorder may be permitted under the protocol.
Suicidal ideation or risk of self-harm that is judged by the PI to be clinicallysignificant and to warrant intervention
Concurrent treatment with opioid medication, or with long-acting or daytimeshort-acting benzodiazepines within two weeks of study start
Current cognitive impairment, as defined by a score <23 on the Montreal CognitiveAssessment (MoCA)
Estimated IQ <80
Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure,cognitive processing therapy).
Study Design
Study Description
Connect with a study center
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
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