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Completed

NCT Number: NCT07444190

Psychological Burden of Thyroid Eye Disease

This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

Thyroid Eye Disease (TED) is an autoimmune disorder in which eye muscles and fatty tissue behind the eye become inflamed and may cause scar tissue to form. Hallmark symptoms of TED include exophthalmos (eye bulging), strabismus (misaligned eyes), diplopia (double vision), dry or gritty eyes, eye pain, eye pressure, sensation of debris in the eye, red eyes, watery eyes, sensitivity to light, blurry vision, eyelid edema (puffy eyes), eyelid retraction, color vision loss, and vision loss. TED affects individuals diagnosed with this condition and their caregivers. This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Clinical diagnosis of Thyroid Eye Disease (patients) OR serving in a caregiving role for someone with a clinical diagnosis of Thyroid Eye Disease (caregivers)

Exclusion criteria

  • Inability to consent or to engage in treatment in English
  • Presence of psychotic disorder or symptoms
  • Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician.
  • Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician

Treatment and study plan

focus groups and individual interviews as well as filling out questionnaires

Other

focus groups and individual interviews as well as filling out questionnaires

Primary outcomes

  1. Understand the experience of people living with TED and of caregivers of people living with TED. The investigators aim to define the different facets of TED-specific psychological burden.

    Time frame: 3 months

    Understand the experience of people living with TED and of caregivers of people living with TED. Through semi-structured individual interviews, focus groups, polls during focus groups, and completion of a battery of standardized self-report measures of depressive symptoms (Beck Depression Inventory-II, Patient Health Questionnaire - 9), anxiety (Generalized Anxiety Disorder -7, Beck Anxiety Inventory), value-based living (Valued Living Questionnaire), and psychological flexibility (cognitive fusion questionnaire -13, acceptance and action questionnaire-2), the investigators aim to define the different facets of TED-specific psychological burden as experienced by patients and by loved ones of people living with TED.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Amgen

Registry information

Official study title

Psychological Burden of Thyroid Eye Disease: A Patient and Caregiver Focus Group and Interview Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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