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GAMBIT Task With PTSD and Healthy Control Participants (GAMBIT)

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GAMBIT Task
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 ≥30 on the CAPS-5 (past-month version) at the time of screening, indicating moderate PTSD symptom severity, of at least 3 months symptom duration.

    • 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).

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PTSD Group

Healthy Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Inhibitory Control Network Flexibility at Baseline
Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.
Inhibitory Control Network Flexibility at Day 52
Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.
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.
PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6
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.
PTSD Checklist for DSM-5 (PCL-5) at Day 23
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.
PTSD Checklist for DSM-5 (PCL-5) at Day 52
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.
Combined Think/No-Think and Go/No-Go Paradigm
The combined Think/No-Think and Go/No-Go paradigm requires participants to learn 35 cue-target word pairs (for approximately 15 minutes) and then asked to alternatively suppress, recall, or think about the cue-target word pairs, when prompted. The percentage of correctly processed trials (go/think trials and no-go/no-think trials) are calculated per block, on a scale from 0% (0/35 trials) to 100% (35/35 trails), with higher recall scores on no-go/no-think trials indicating worse inhibitory control.
Face-Stroop Task
The Face-Stroop task is a modified version of the widely used Stroop task which assesses reaction time between congruent and incongruent stimuli. During the Face-Stroop task, participants are simultaneously presented with images of emotional faces and emotional words (e.g., "Happy", "Sad"), with some trials presenting congruent stimuli (happy face + "Happy") and other trials presenting incongruent stimuli (happy face + "Sad"), and asked to identify the faces and words separately. Variables of interest include reaction time (range 250-1000 milliseconds, with lower RT indicating better performance) and accuracy (0-100%, with greater accuracy denoting better performance).

Full Information

First Posted
March 28, 2022
Last Updated
January 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05313334
Brief Title
GAMBIT Task With PTSD and Healthy Control Participants
Acronym
GAMBIT
Official Title
Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTSD Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GAMBIT Task
Intervention Description
The GAMBIT task is a novel inhibitory control task. Participants in the PTSD group will receive the GAMBIT intervention repeatedly over the study period.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Baseline
Description
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
Title
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23
Description
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
Day 23
Title
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 52
Description
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
Day 52
Secondary Outcome Measure Information:
Title
Inhibitory Control Network Flexibility at Baseline
Description
Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.
Time Frame
Baseline
Title
Inhibitory Control Network Flexibility at Day 52
Description
Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.
Time Frame
Day 52
Title
PTSD Checklist for DSM-5 (PCL-5) at Baseline
Description
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.
Time Frame
Baseline
Title
PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6
Description
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.
Time Frame
Weekly [Weeks 1-6]
Title
PTSD Checklist for DSM-5 (PCL-5) at Day 23
Description
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.
Time Frame
Day 23
Title
PTSD Checklist for DSM-5 (PCL-5) at Day 52
Description
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.
Time Frame
Day 52
Title
Combined Think/No-Think and Go/No-Go Paradigm
Description
The combined Think/No-Think and Go/No-Go paradigm requires participants to learn 35 cue-target word pairs (for approximately 15 minutes) and then asked to alternatively suppress, recall, or think about the cue-target word pairs, when prompted. The percentage of correctly processed trials (go/think trials and no-go/no-think trials) are calculated per block, on a scale from 0% (0/35 trials) to 100% (35/35 trails), with higher recall scores on no-go/no-think trials indicating worse inhibitory control.
Time Frame
up to 52 days
Title
Face-Stroop Task
Description
The Face-Stroop task is a modified version of the widely used Stroop task which assesses reaction time between congruent and incongruent stimuli. During the Face-Stroop task, participants are simultaneously presented with images of emotional faces and emotional words (e.g., "Happy", "Sad"), with some trials presenting congruent stimuli (happy face + "Happy") and other trials presenting incongruent stimuli (happy face + "Sad"), and asked to identify the faces and words separately. Variables of interest include reaction time (range 250-1000 milliseconds, with lower RT indicating better performance) and accuracy (0-100%, with greater accuracy denoting better performance).
Time Frame
up to 52 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) 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 ≥30 on the CAPS-5 (past-month version) at the time of screening, indicating moderate PTSD symptom severity, of at least 3 months symptom duration. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan DePierro, PhD
Phone
212-241-6539
Email
jonathan.depierro@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laurel Morris, PhD
Phone
212-241-2774
Email
laurel.morris@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan DePierro, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan DePierro, PhD
Phone
212-241-6539
Email
jonathan.depierro@mssm.edu
First Name & Middle Initial & Last Name & Degree
Laurel Morris, PhD
Phone
212-241-2774
Email
laurel.morris@mssm.edu
First Name & Middle Initial & Last Name & Degree
Jonathan DePierro

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.

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GAMBIT Task With PTSD and Healthy Control Participants

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