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Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items Among People With Systemic Sclerosis

NCT06772896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 851

Last updated 2025-09-09

No results posted yet for this study

Summary

There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease. However, it has been shown in previous studies that biases associated with somatic items do not affect total depression scores. The reason for this is still unclear but could be associated with the context in which these items are presented.

The goal of this experiment is to learn whether the way people with systemic sclerosis answer somatic items on a depression questionnaire is influenced by the fact that they are aware they are being assessed for depressive symptoms.

The main question it aims to answer is: Do people with systemic sclerosis score somatic items differently when they are administered outside the context of a depression questionnaire? Participants will be randomly assigned to complete the 8-item Patient Health Questionnaire as part of their routine cohort assessments either with the items in their standard order or with somatic items presented first and separately from psychological items.

Conditions

  • Scleroderma
  • Systemic Sclerosis (SSc)
  • Scleroderma (Limited and Diffuse)

Interventions

OTHER

Reordered PHQ-8

Participants will be administered the PHQ-8 somatic items separately from the psychological items, outside the context of a depression questionnaire.

Sponsors & Collaborators

  • Lady Davis Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2025-04-17
Completion
2025-04-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772896 on ClinicalTrials.gov