Digital training task for PTSD and healthy participants
Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)
This study tests whether a computer-based training program can help people with PTSD feel better and improve their mental flexibility, while also including healthy participants for comparison.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05313334 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the GAMBIT task, a computerized intervention aimed at improving mental health symptoms associated with Posttraumatic Stress Disorder (PTSD). It will assess the relationship between task completion and brain circuit flexibility, behavior, and PTSD symptoms over time. Participants will include individuals diagnosed with PTSD and healthy controls, with data collected through functional neuroimaging and symptom ratings. The study aims to determine the efficacy of the GAMBIT task in enhancing cognitive flexibility and reducing PTSD symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-55 who meet the diagnostic criteria for current PTSD or are healthy controls with no psychiatric history.
Not a fit: Patients with a current or lifetime history of schizophrenia or other severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel therapeutic approach for improving symptoms of PTSD.
How similar studies have performed: While this approach is innovative, similar studies exploring cognitive interventions for PTSD have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan DePierro, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Jonathan DePierro, PhD
- Email: jonathan.depierro@mssm.edu
- Phone: 212-241-6539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.