- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07849907
The Parasite and Infestation Study
Understanding the Experience of Patient-Physician Diagnostic Incongruency: I Know Something is Wrong But No One Believes Me
Many people have evidence of bugs, parasites, and infestation, but are told by others that they cannot find a cause. This distressing and frustrating experience can last for years, as the person seeks answers. The current study aims to understand the experience of these individuals. In a 1-2 hour session over Zoom, the investigators will ask participants questions about their experience, have them complete self-report questionnaires, and ask them to complete a few games on the computer. The investigators' goal is to help characterize and understand individuals with this experience to aid in better treatment and inform recommendations for providers.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The current study aims to characterize the experiences of people who have evidence of bugs, parasites, and/or infestation but are told by physicians or other professionals (e.g. vets, pest control) that there is nothing wrong. The investigators seek to understand the emotional and cognitive aspects of this experience, through semi-structured interviews, self-report questionnaires, and cognitive tasks. The study will take a few hours and is conducted remotely, allowing for participation regardless of the participant's physical location. There is practically no aggregate information on this experience, with most current information relying on case reports and medical record review. The investigators hope to provide greater insights into this experience to guide support for individuals going through this difficult process.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Sheffield Lab
- Telefonnummer: (615) 686-2488
- E-mail: sheffieldlab.vumc@gmail.com
Studiesteder
-
-
Tennessee
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Nashville, Tennessee, Forenede Stater, 37212
- Rekruttering
- Vanderbilt University Medical Center
-
Kontakt:
- Sheffield Lab
- Telefonnummer: (615) 686-2488
- E-mail: sheffieldlab.vumc@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adults with a persistent experience of infestation or parasite that physicians or other professionals report no evidence for.
Beskrivelse
Inclusion Criteria:
- Men and women aged 18-70 years old
- At least 50% certain that they have an active infection/infestation/parasite, despite being told by doctor that they do not
- Ability to read and speak English
- Access to a computer or phone for virtual visit
- No self-reported history of schizophrenia-spectrum disorder
Exclusion Criteria:
- Active substance use disorder (excluding nicotine and caffeine)
- History of severe head trauma
- Current use of antipsychotics
- Serious medical or neurological illness known to interfere with cognitive functioning
- Diagnosis of a learning disability or cognitive disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
PPDI Group
|
This study will not involve an intervention. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychological Wellbeing
Tidsramme: Baseline
|
Total score on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); scores range from 14-70; higher scores reflect greater wellbeing |
Baseline
|
|
Social Network
Tidsramme: Baseline
|
Ludden Social Network Scale - total score; higher scores reflect larger and closer social network (score: 0-30) |
Baseline
|
|
Depression
Tidsramme: Baseline
|
Total score - Beck Depression Inventory -II; Scores range from 0-63 with higher scores reflecting worse depression |
Baseline
|
|
Anxiety
Tidsramme: Baseline
|
Perseverative Thinking Questionnaire (PTQ); scores range from 0-60, higher scores reflect more perseveration |
Baseline
|
|
Belief Updating
Tidsramme: Baseline
|
Expectations of prior volatility (mu3) calculated from reversal learning task; higher parameter scores reflect greater expectations of volatility |
Baseline
|
|
BADE
Tidsramme: Baseline
|
Evidence Integration Impairment (EII) will be calculated based on decisions on the Bias Against Disconfirmatory Evidence task. Higher scores reflect more difficulty integrating information |
Baseline
|
|
Interoceptive Awareness
Tidsramme: Baseline
|
Multidimensional Assessment of Interoceptive Awareness-2; scores range from 0-185; higher scores reflect better interpersonal awareness |
Baseline
|
|
Dissociation
Tidsramme: Baseline
|
Cernis Felt Sense of Anomaly Scale (CEFSA); scores range from 0-140, higher scores reflect more severe dissociative experiences |
Baseline
|
|
Childhood Trauma
Tidsramme: Baseline
|
Childhood Trauma Questionnaire (CTQ)- scores range from 5-100, higher scores reflect more severe childhood maltreatment |
Baseline
|
|
DACOBS
Tidsramme: Baseline
|
Davos Assessment of Cognitive Biases Scale; higher scores reflect more severe cognitive biases. Scores range from 42-294 |
Baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Julia Sheffield, PhD, Vanderbilt University Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201489
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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