- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sheffield Lab
- 전화번호: (615) 686-2488
- 이메일: sheffieldlab.vumc@gmail.com
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37212
- 모병
- Vanderbilt University Medical Center
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연락하다:
- Sheffield Lab
- 전화번호: (615) 686-2488
- 이메일: sheffieldlab.vumc@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adults with a persistent experience of infestation or parasite that physicians or other professionals report no evidence for.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
PPDI Group
|
This study will not involve an intervention. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Psychological Wellbeing
기간: Baseline
|
Total score on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS); scores range from 14-70; higher scores reflect greater wellbeing |
Baseline
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Social Network
기간: Baseline
|
Ludden Social Network Scale - total score; higher scores reflect larger and closer social network (score: 0-30) |
Baseline
|
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Depression
기간: Baseline
|
Total score - Beck Depression Inventory -II; Scores range from 0-63 with higher scores reflecting worse depression |
Baseline
|
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Anxiety
기간: Baseline
|
Perseverative Thinking Questionnaire (PTQ); scores range from 0-60, higher scores reflect more perseveration |
Baseline
|
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Belief Updating
기간: Baseline
|
Expectations of prior volatility (mu3) calculated from reversal learning task; higher parameter scores reflect greater expectations of volatility |
Baseline
|
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BADE
기간: 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
기간: Baseline
|
Multidimensional Assessment of Interoceptive Awareness-2; scores range from 0-185; higher scores reflect better interpersonal awareness |
Baseline
|
|
Dissociation
기간: Baseline
|
Cernis Felt Sense of Anomaly Scale (CEFSA); scores range from 0-140, higher scores reflect more severe dissociative experiences |
Baseline
|
|
Childhood Trauma
기간: Baseline
|
Childhood Trauma Questionnaire (CTQ)- scores range from 5-100, higher scores reflect more severe childhood maltreatment |
Baseline
|
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DACOBS
기간: Baseline
|
Davos Assessment of Cognitive Biases Scale; higher scores reflect more severe cognitive biases. Scores range from 42-294 |
Baseline
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Julia Sheffield, PhD, Vanderbilt University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201489
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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