Status:
TERMINATED
GAMBIT Task With PTSD and Healthy Control Participants
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, ...
Detailed Description
This is a single-site pilot study for the GAMBIT intervention, which is a computerized task that addresses behavioral inhibition. The primary objective of this study is to determine whether the GAMBIT...
Eligibility Criteria
Inclusion
- 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 sufficient to agree to all tests and examinations required by the study and must be able to participate 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 and Statistical 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 the time of screening, indicating moderate PTSD symptom severity.
- Healthy Control Group:
- i. Has no lifetime history of any psychiatric disorder
Exclusion
- Current or lifetime history of schizophrenia or other psychotic disorder, bipolar disorder, 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 medications as per study protocol; intermittent cannabis use that does not meet criteria for a substance use disorder may be permitted under the protocol.
- Suicidal ideation or risk of self-harm that is judged by the PI to be clinically significant and to warrant intervention
- Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start
- Current cognitive impairment, as defined by a score \<23 on the Montreal Cognitive Assessment (MoCA)
- Estimated IQ \<80
- Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy).
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05313334
Start Date
November 18 2022
End Date
October 29 2024
Last Update
October 6 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029