TERMINATED

GAMBIT Task With PTSD and Healthy Control Participants

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)

Quick Facts

Study Start:2022-11-18

Study Completion:2024-10-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05313334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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: 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:	* 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).

Inclusion Criteria

Exclusion 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:
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:

* 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).

Contacts and Locations

Principal Investigator

Jonathan DePierro, PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Jonathan DePierro, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-18

Study Completion Date2024-10-29

Study Record Updates

Study Start Date2022-11-18

Study Completion Date2024-10-29

Terms related to this study

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder