Clinical trial NCT05313334: GAMBIT Task with PTSD and Healthy Control Participants
Official title: Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, and symptoms in participants with PTSD.

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 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.

Eligibility 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).

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Baseline
timeFrame: Baseline
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23
timeFrame: Day 23
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 52
timeFrame: Day 52
Secondary outcomes:
measure: Inhibitory Control Network Flexibility at Baseline
timeFrame: Baseline
measure: Inhibitory Control Network Flexibility at Day 52
timeFrame: Day 52
measure: PTSD Checklist for DSM-5 (PCL-5) at Baseline
timeFrame: Baseline
measure: PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6
timeFrame: Weekly [Weeks 1-6]
measure: PTSD Checklist for DSM-5 (PCL-5) at Day 23
timeFrame: Day 23
measure: PTSD Checklist for DSM-5 (PCL-5) at Day 52
timeFrame: Day 52
measure: Combined Think/No-Think and Go/No-Go Paradigm
timeFrame: up to 52 days
measure: Face-Stroop Task
timeFrame: up to 52 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jonathan DePierro, PhD
role: PRINCIPAL_INVESTIGATOR
References: