Psychological Burden of Thyroid Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Eye Disease, TED
• Intervention / Treatment: Other: focus groups and individual interviews as well as filling out questionnaires

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People living with TED and their loved ones

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients living with TED and their loved ones; interviews, focus groups & completion of questionnaires by patients living w TED and their loved ones	Other: focus groups and individual interviews as well as filling out questionnaires; focus groups and individual interviews as well as filling out questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Amgen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: TED, thyroid eye disease
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Focus Groups
• Other Study ID Numbers: iRISID-2024-3013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data to be shared w patrick smith, phd mph for statistical analyses
• IPD Sharing Time Frame: 10/1/2025-12/31/2025
• IPD Sharing Access Criteria: patrick smith, phd mph for statistical analyses
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No