GAMBIT Task With PTSD and Healthy Control Participants

NCT05313334 | Terminated

• 1 other identifier: STUDY-21-01108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

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

  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.

  Day 23

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

  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.

  Day 52

Secondary Outcomes (8)

• Inhibitory Control Network Flexibility at Baseline

  Baseline

• Inhibitory Control Network Flexibility at Day 52

  Day 52

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

  Baseline

• PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6

  Weekly [Weeks 1-6]

• PTSD Checklist for DSM-5 (PCL-5) at Day 23

  Day 23

Study Arms (2)

PTSD Group

EXPERIMENTAL

The PTSD Group will receive the GAMBIT intervention and complete all study tasks and assessments at every study visit (Visits 0-4). N=20 participants will be recruited for this arm.

Behavioral: GAMBIT Task

Healthy Control Group

EXPERIMENTAL

The Healthy Control Group will receive the GAMBIT intervention and complete all study tasks and assessments at every study visit (Visits 0-4). N=20 participants will be recruited for this arm. Additionally, N=10 Healthy Control participants will be recruited for the Pilot Phase of the study.

Behavioral: GAMBIT Task

Interventions

GAMBIT Task BEHAVIORAL

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.

Healthy Control Group; PTSD Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jonathan DePierro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychiatry

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 6, 2022
• Study Start: November 18, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.

Locations

US (1)