NCT07849907

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
51mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Dec 2024Dec 2030

Study Start

First participant enrolled

December 31, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

4.9 years

First QC Date

September 18, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

parasitesinfestationMorgellons Diseasebugs crawlingtactile

Outcome Measures

Primary Outcomes (10)

  • Psychological Wellbeing

    Total score on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); scores range from 14-70; higher scores reflect greater wellbeing

    Baseline

  • Social Network

    Ludden Social Network Scale - total score; higher scores reflect larger and closer social network (score: 0-30)

    Baseline

  • Depression

    Total score - Beck Depression Inventory -II; Scores range from 0-63 with higher scores reflecting worse depression

    Baseline

  • Anxiety

    Perseverative Thinking Questionnaire (PTQ); scores range from 0-60, higher scores reflect more perseveration

    Baseline

  • Belief Updating

    Expectations of prior volatility (mu3) calculated from reversal learning task; higher parameter scores reflect greater expectations of volatility

    Baseline

  • BADE

    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

    Multidimensional Assessment of Interoceptive Awareness-2; scores range from 0-185; higher scores reflect better interpersonal awareness

    Baseline

  • Dissociation

    Cernis Felt Sense of Anomaly Scale (CEFSA); scores range from 0-140, higher scores reflect more severe dissociative experiences

    Baseline

  • Childhood Trauma

    Childhood Trauma Questionnaire (CTQ)- scores range from 5-100, higher scores reflect more severe childhood maltreatment

    Baseline

  • DACOBS

    Davos Assessment of Cognitive Biases Scale; higher scores reflect more severe cognitive biases. Scores range from 42-294

    Baseline

Study Arms (1)

PPDI Group

Other: No intervention - observational study

Interventions

This study will not involve an intervention.

PPDI Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a persistent experience of infestation or parasite that physicians or other professionals report no evidence for.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Parasitic DiseasesMorgellons Disease

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Julia Sheffield, PhD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 30, 2026

Study Start

December 31, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations