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Thermoregulation Among Individuals With First-episode Psychosis

Studies

Study First Submitted Date 2020-04-27
Study First Posted Date 2020-04-30
Last Update Posted Date 2023-08-02
Start Month Year November 1, 2023
Primary Completion Month Year April 3, 2025
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-08-02

Detailed Descriptions

Sequence: 20659939
Description 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.

Facilities

Sequence: 199422758
Name Harding Hospital
City Columbus
State Ohio
Zip 43210
Country United States

Facility Contacts

Sequence: 28027032
Facility Id 199422758
Contact Type primary
Name Nicholas Breitborde, PhD
Email nicholas.breitborde@osumc.edu
Phone 614-685-6052

Conditions

Sequence: 52010675 Sequence: 52010676
Name Psychosis Name First Episode Psychosis
Downcase Name psychosis Downcase Name first episode psychosis

Id Information

Sequence: 40033171
Id Source org_study_id
Id Value 2020H0066

Countries

Sequence: 42429289
Name United States
Removed False

Design Groups

Sequence: 55416395 Sequence: 55416396
Title First-Episode Psychosis Title Healthy
Description Twenty individuals with FEP will complete a 24-hour continuous assessment of core body temperature using a CorTemp ingestible sensor (HQInc., Palmetto, FL). Description 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).

Design Outcomes

Sequence: 176817864 Sequence: 176817865 Sequence: 176817866
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Differences in mean temperature and diurnal temperature variation Measure Differences in mean temperature and temperature variation during periods of rest and activity Measure Association of core body temperature and ratings of psychotic symptomatology in FEP
Time Frame 24 hour intervals Time Frame 24 hour intervals Time Frame 24 hour intervals
Description Differences in mean temperature and diurnal temperature variation in individuals with first-episode psychosis as compared to individuals without psychosis. Description Differences in mean temperature and temperature variation during periods of rest and activity between individuals with first-episode psychosis versus people without psychosis. Description Association between core body temperature and ratings of psychotic symptomatology among individuals with first-episode psychosis.

Browse Conditions

Sequence: 192851176 Sequence: 192851177 Sequence: 192851178
Mesh Term Psychotic Disorders Mesh Term Mental Disorders Mesh Term Schizophrenia Spectrum and Other Psychotic Disorders
Downcase Mesh Term psychotic disorders Downcase Mesh Term mental disorders Downcase Mesh Term schizophrenia spectrum and other psychotic disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48169421
Agency Class OTHER
Lead Or Collaborator lead
Name Nicholas Breitborde

Central Contacts

Sequence: 11972918
Contact Type primary
Name Nicholas Breitborde, PhD
Phone (614) 685-6052
Email nicholas.breitborde@osumc.edu
Role Contact

Eligibilities

Sequence: 30671313
Sampling Method Non-Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age 35 Years
Healthy Volunteers Accepts Healthy Volunteers
Population 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-4.
Criteria 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-4. 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-5. 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-4. 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 < 12.5. 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
Adult True
Child False
Older Adult False

Calculated Values

Sequence: 254297502
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 35
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30418085
Observational Model Case-Control
Time Perspective Prospective

Responsible Parties

Sequence: 28784598
Responsible Party Type Sponsor-Investigator
Name Nicholas Breitborde
Title Associate Professor
Affiliation Ohio State University

Study References

Sequence: 51898951 Sequence: 51898971 Sequence: 51898950 Sequence: 51898952 Sequence: 51898953 Sequence: 51898954 Sequence: 51898955 Sequence: 51898956 Sequence: 51898957 Sequence: 51898958 Sequence: 51898959 Sequence: 51898960 Sequence: 51898961 Sequence: 51898962 Sequence: 51898963 Sequence: 51898964 Sequence: 51898965 Sequence: 51898966 Sequence: 51898967 Sequence: 51898968 Sequence: 51898969 Sequence: 51898970 Sequence: 51898972 Sequence: 51898973 Sequence: 51898974
Pmid 2927577 Pmid 19011447 Pmid 3251495 Pmid 8398951 Pmid 21978215 Pmid 20438740 Pmid 11564466 Pmid 17996259 Pmid 26629908 Pmid 15469188 Pmid 8370796 Pmid 19493658 Pmid 22488144 Pmid 23075387 Pmid 10867307 Pmid 17588237 Pmid 21671239 Pmid 26794588 Pmid 2748771 Pmid 3616518
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
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