Thermoregulation Among Individuals With First-episode Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Differences in mean temperature and temperature variation during periods of rest and activity
研究概览
简要总结
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.
详细描述
The project will evaluate thermoregulatory processes among individuals with and without first-episode psychosis.
Aim 1: Assess whether individuals with first-episode psychosis have differences in mean temperature and diurnal temperature variation as compared to individuals without psychosis.
Aim 2: Examine whether mean temperature and temperature variation during periods of rest and activity are different between individuals with first-episode psychosis versus people without psychosis.
Aim 3: Explore the association between current core body temperature and current ratings of psychotic symptomatology among individuals with first-episode psychosis.
Study participants will complete baseline assessments (e.g., symptoms, functioning, and sleep) and then complete a 24-36 hour ambulatory assessment period in which core temperature, activity, sleep, and heart rate variability will be tracked continuously and symptom severity will be assessed sporadically using a symptom rating app on their smart phone. .Then they will complete a second study visit to repeat baseline assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility for Individuals with First-Episode Psychosis:
- •Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5 .
- •Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory.
- •No evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-
- •Eligibility for Individuals without First-Episode Psychosis:
- •No diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-
- •No evidence of a pre-existing intellectual disability defined as a premorbid IQ >70 as estimated using the Reading subtest of the Wide Range Achievement Test-
- •Eligibility for Individuals with and without First-Episode Psychosis:
- •Ages 18 - 35
- •No evidence of swallowing difficulties as assessed using the Swallowing Disturbance Questionnaire [SDQ]. defined as (i) a score <5 on the SDQ oral phase questions, (ii) a score <11.5 on the laryngopharygeal phase SDQ questions, and a total SDQ score < 12.
- •Not meeting diagnostic criteria for a substance use disorder over the past month as determined using the Structured Clinical Interview for the DSM-5 .
- •No current or past diagnosis of a medical condition known to affect thermoregulatory Functioning as assessed using the Health Conditions that Affect Thermoregulation questionnaire
- •Per recommendations from the manufacturer of the CorTemp continuous temperature sensor, we will not enroll:
- •Individuals who weigh less than 80 pounds
- •Individuals diagnosed with known or suspected obstructive diseases of the gastrointestinal tract
- •Individuals with a history of gag reflex disorders or impairments
- •Individuals with previous or scheduled gastrointestinal surgery
- •Individuals having felinization of the esophagus
- •Individuals with conditions that would result in hypomotility of the GI tract.
- •Individuals scheduled to undergo Magnetic Resonance Imaging or Nuclear Magnetic Resonance in the next month
- •Individuals with cardiac pacemaker or other implanted electric medical devices
排除标准
- 未提供
研究组 & 干预措施
First-Episode Psychosis
Twenty individuals with FEP will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL).
Healthy
Twenty age-matched individuals with no psychotic disorder will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL).
结局指标
主要结局
Differences in mean temperature and temperature variation during periods of rest and activity
时间窗: 24 hour intervals
Differences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis.
Association of core body temperature and ratings of psychotic symptomatology in FEP
时间窗: 24 hour intervals
Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.
Differences in mean temperature and diurnal temperature variation
时间窗: 24 hour intervals
Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis.
次要结局
未报告次要终点
研究者
Nicholas Breitborde
Associate Professor
Ohio State University