Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23
时间窗: 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 Baseline
时间窗: 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 52
时间窗: 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.
次要结局
- PTSD Checklist for DSM-5 (PCL-5) at Day 52(Day 52)
- PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6(Weekly [Weeks 1-6])
- PTSD Checklist for DSM-5 (PCL-5) at Baseline(Baseline)
- PTSD Checklist for DSM-5 (PCL-5) at Day 23(Day 23)
- Combined Think/No-Think and Go/No-Go Paradigm(up to 52 days)
- Inhibitory Control Network Flexibility at Baseline(Baseline)
- Inhibitory Control Network Flexibility at Day 52(Day 52)
- Face-Stroop Task(up to 52 days)
研究者
Jonathan M DePierro
Associate Professor, Psychiatry
Icahn School of Medicine at Mount Sinai