What side effects are associated with this type of intervention?

Cognitive-behavioral therapy (CBT) for PTSD, including exposure-based therapies, is generally well-tolerated but can sometimes lead to temporary increases in distress or anxiety as patients confront traumatic memories. Common side effects of pharmacotherapy for PTSD, such as selective serotonin reuptake inhibitors (SSRIs), include nausea, insomnia, sexual dysfunction, and increased anxiety. Combining CBT with pharmacotherapy may enhance treatment efficacy but also carries the risk of combined side effects from both modalities.

What prior FDA approvals exist?

The FDA has approved several treatments for Post-Traumatic Stress Disorder (PTSD), primarily focusing on pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. These medications help alleviate symptoms by modulating neurotransmitter levels. Additionally, cognitive-behavioral therapy (CBT), including exposure therapy and cognitive processing therapy, is widely recognized and recommended for PTSD treatment. While the GAMBIT Digital Training Task is a novel approach focusing on cognitive and behavioral training to improve brain circuit flexibility, it aligns with the broader category of CBT, which has substantial evidence supporting its efficacy in treating PTSD.

What other types of research exist?

Promising novel alternatives to the GAMBIT Digital Training Task for PTSD treatment include Cognitive Processing Therapy (CPT), which has shown significant improvements in PTSD and comorbid symptoms, and computerized imaginal exposure training, which has demonstrated efficacy in reducing physiological responses to trauma. Additionally, neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct-current stimulation (tDCS) are emerging as potential treatments for PTSD.

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Behavioral Intervention

GAMBIT Task for PTSD (GAMBIT Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include Cognitive Behavioral Therapy (CBT) and its variants like Trauma-Focused CBT (TF-CBT). These therapies aim to reframe negative thought patterns and reduce avoidance behaviors linked to trauma. Techniques such as exposure therapy help desensitize patients to trauma-related triggers, improving brain circuit flexibility. This is essential for PTSD patients as it addresses the cognitive and emotional dysregulation that sustains their symptoms, thereby reducing hyperarousal and enhancing emotional regulation.

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

Healthy Control Group: Has no lifetime history of any psychiatric disorder

Male or female aged 18-55 years

Must not have

Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy)

Estimated IQ <80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a computer-based exercise called GAMBIT to help people with PTSD improve their behavior control. The goal is to see if this can reduce PTSD symptoms by enhancing their ability to manage reactions and behaviors.

Who is the study for?

This trial is for men and women aged 18-55 who either have PTSD or are healthy controls without any psychiatric disorders. Participants must understand English well enough to consent and complete study requirements. Those with moderate PTSD symptoms for at least 3 months can join, but not if they're on certain medications, have cognitive impairments, substance use disorders within the last year, or are currently in specific psychotherapies for PTSD.

What is being tested?

The GAMBIT Task pilot study is testing a digital training task to see how it affects brain flexibility, behavior, and symptoms in people with PTSD compared to healthy individuals without psychiatric conditions.

What are the potential side effects?

Since this trial involves a digital training task rather than medication or invasive procedures, traditional side effects like those seen with drugs are not expected. However, participants may experience discomfort or stress related to the content of the tasks.

Eligibility Criteria

Inclusion Criteria

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

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I have never been diagnosed with a psychiatric disorder.

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I am between 18 and 55 years old.

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I have PTSD with moderate symptoms from a traumatic event.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in therapy for PTSD using recognized methods.

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My IQ is below 80.

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I have never been diagnosed with schizophrenia, bipolar disorder, OCD, an eating disorder, or any neurodevelopmental or neurocognitive disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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 GroupExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include Cognitive Behavioral Therapy (CBT) and its variants like Trauma-Focused CBT (TF-CBT). These therapies aim to reframe negative thought patterns and reduce avoidance behaviors linked to trauma. Techniques such as exposure therapy help desensitize patients to trauma-related triggers, improving brain circuit flexibility. This is essential for PTSD patients as it addresses the cognitive and emotional dysregulation that sustains their symptoms, thereby reducing hyperarousal and enhancing emotional regulation.

A Pilot Study Assessing the Effects of Goal Management Training on Cognitive Functions among Individuals with Major Depressive Disorder and the Effect of Post-Traumatic Symptoms on Response to Intervention.