- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Sheffield Lab
- Telefonnummer: (615) 686-2488
- E-post: sheffieldlab.vumc@gmail.com
Studieorter
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37212
- Rekrytering
- Vanderbilt University Medical Center
-
Kontakt:
- Sheffield Lab
- Telefonnummer: (615) 686-2488
- E-post: sheffieldlab.vumc@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adults with a persistent experience of infestation or parasite that physicians or other professionals report no evidence for.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
PPDI Group
|
This study will not involve an intervention. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychological Wellbeing
Tidsram: Baseline
|
Total score on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); scores range from 14-70; higher scores reflect greater wellbeing |
Baseline
|
|
Social Network
Tidsram: Baseline
|
Ludden Social Network Scale - total score; higher scores reflect larger and closer social network (score: 0-30) |
Baseline
|
|
Depression
Tidsram: Baseline
|
Total score - Beck Depression Inventory -II; Scores range from 0-63 with higher scores reflecting worse depression |
Baseline
|
|
Anxiety
Tidsram: Baseline
|
Perseverative Thinking Questionnaire (PTQ); scores range from 0-60, higher scores reflect more perseveration |
Baseline
|
|
Belief Updating
Tidsram: Baseline
|
Expectations of prior volatility (mu3) calculated from reversal learning task; higher parameter scores reflect greater expectations of volatility |
Baseline
|
|
BADE
Tidsram: 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
Tidsram: Baseline
|
Multidimensional Assessment of Interoceptive Awareness-2; scores range from 0-185; higher scores reflect better interpersonal awareness |
Baseline
|
|
Dissociation
Tidsram: Baseline
|
Cernis Felt Sense of Anomaly Scale (CEFSA); scores range from 0-140, higher scores reflect more severe dissociative experiences |
Baseline
|
|
Childhood Trauma
Tidsram: Baseline
|
Childhood Trauma Questionnaire (CTQ)- scores range from 5-100, higher scores reflect more severe childhood maltreatment |
Baseline
|
|
DACOBS
Tidsram: Baseline
|
Davos Assessment of Cognitive Biases Scale; higher scores reflect more severe cognitive biases. Scores range from 42-294 |
Baseline
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Julia Sheffield, PhD, Vanderbilt University Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201489
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .