GAMBIT Task with PTSD and Healthy Control Participants

Last updated: January 12, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

GAMBIT Task

Clinical Study ID

NCT05313334
STUDY-21-01108
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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)

  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 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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: GAMBIT Task
Phase:
Study Start date:
November 18, 2022
Estimated Completion Date:
December 31, 2026

Study 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 task improves mental health symptoms associated with PTSD over time. The secondary objective of this study is to determine whether the GAMBIT task promotes flexibility in inhibitory control network as determined by functional neuroimaging. Additional laboratory measures associated with cognitive flexibility, and clinician and patient-rated symptom data, will be collected.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

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