GAMBIT Task With PTSD and Healthy Control Participants

ID#: NCT05313334

Age: 18 - 55 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 01, 2022

End Date: December 01, 2024

Contact Information:
Jonathan DePierro, PhD
Laurel Morris, PhD
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, and symptoms in participants with PTSD.

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 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)

1. Has been exposed to a Criterion A trauma of the civilian type (e.g., non-combat, threatened or actual interpersonal violence) or non-civilian

2. 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 Criteria:

- 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).