GAMBIT Task With PTSD and Healthy Control Participants

Icahn School of Medicine at Mount Sinai50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Posttraumatic Stress Disorder

Interventions

GAMBIT TaskBEHAVIORAL

The GAMBIT task is a novel inhibitory control task. Participants in the Healthy Control group will receive the GAMBIT intervention repeatedly over the study period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Baseline

The CAPS is a structured clinical interview designed to assess the essential features of PTSD. A total symptom severity score is calculated on a scale of 0-80, with a higher score representing greater symptom severity.

Time frame: Baseline

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23

Time frame: Day 23

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 52

Time frame: Day 52

Secondary Outcomes

Inhibitory Control Network Flexibility at Baseline

Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.

Time frame: Baseline

Inhibitory Control Network Flexibility at Day 52

Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.

Time frame: Day 52

PTSD Checklist for DSM-5 (PCL-5) at Baseline

The PTSD Checklist for DSM-5 (PCL-5) is a widely used clinical self-report scale to evaluate current symptoms of PTSD. Each question on the 20-item checklist corresponds to a symptom of PTSD in the DSM-5. A total severity score is calculated on a scale of 0-80, with a higher score indicating greater severity.

Data from ClinicalTrials.gov

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