Behavioral Intervention

GAMBIT Task for Post-Traumatic Stress Disorder

N/A

Recruiting

Led By Jonathan DePierro, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- PTSD Group:

i. Meets diagnostic criteria for current PTSD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5)

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will study the effects of a digital task called GAMBIT on brain circuits, behavior, and symptoms in people with PTSD.

Eligible Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are a part of the PTSD group.

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You have been diagnosed with PTSD according to the official guidelines for mental disorders.

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You have experienced a traumatic event, like violence or a dangerous situation, that has affected you emotionally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

Combined Think/No-Think and Go/No-Go Paradigm

Face-Stroop Task

Inhibitory Control Network Flexibility at Baseline

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PTSD GroupExperimental Treatment1 Intervention

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.

Group II: Healthy Control GroupActive Control1 Intervention

The Healthy Control Group will only complete study tasks and assessments at the screening visit (Visit 0) and the Pre-Assessment visit (Visit 1). This arm will not receive any intervention. 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.

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

824 Previous Clinical Trials

514,026 Total Patients Enrolled

Jonathan DePierro, PhDPrincipal Investigator

Icahn School of Medicine at Mount Sinai

Media Library

GAMBIT Task (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05313334 — N/A

Post-Traumatic Stress Disorder Research Study Groups: PTSD Group, Healthy Control Group

Post-Traumatic Stress Disorder Clinical Trial 2023: GAMBIT Task Highlights & Side Effects. Trial Name: NCT05313334 — N/A

GAMBIT Task (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05313334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity for this clinical research?

"Affirmative. Information gathered from clinicaltrials.gov confirms that this experiment, which first appeared on October 1st 2022, is actively seeking individuals who meet the criteria to take part. The researchers are looking for 50 people at a single medical site."

Answered by AI

Do I qualify for participation in this research study?

"Aspiring participants of this clinical trial should be between 18 and 55 years old, have an understanding of the English language sufficient to comprehend informed consent processes, meet diagnostic criteria for PTSD according to DSM-5 standards with a score of at least 30 on CAPS-5 exams, possess no prior history of any psychiatric disorder, yet must have experienced a civilian or non-civilian traumatic event. A total amount of 50 individuals will be accepted into this study."

Answered by AI

Does this study accept participants that are younger than 40 years old?

"As per the instructions detailed in the inclusion criteria, individuals must be at least 18 years old and not exceed 55 to enroll."

Answered by AI

Is it possible to sign up for this experiment at present?

"Indeed, clinicaltrials.gov displays information that this research project is recruiting individuals at the time of writing. This trial was first posted on October 1st 2022 and has since been updated as recently as October 17th 2022. In total, 50 participants need to be sourced from a single medical centre."

Answered by AI

What is the desired outcome of this clinical research?

"The CAPS-5 score at Day 52 serves as the primary measurement for this clinical trial to evaluate its success. Secondary assessments, such as PCL-5 scores taken on day 23 and weekly during the first 6 weeks will also be used. Additionally, a final PCL-5 score is expected after Week 52."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GAMBIT Task With PTSD and Healthy Control Participants

Jonathan M Depierro 2022. "GAMBIT Task With PTSD and Healthy Control Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05313334.