Evaluating how questionnaire context affects depression reporting in systemic sclerosis patients
Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items in the 8-item Patient Health Questionnaire Among People with Systemic Sclerosis: a Scleroderma Patient-centered Intervention Network (SPIN) Study
NA · Lady Davis Institute · NCT06772896
This study tests how the way questions are asked affects how people with systemic sclerosis report their depression symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 798 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lady Davis Institute (other) |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06772896 on ClinicalTrials.gov |
What this trial studies
This study investigates how the context in which somatic symptoms are assessed influences the reporting of depression in individuals with systemic sclerosis. Participants will complete the 8-item Patient Health Questionnaire (PHQ-8) in different contexts to determine if their responses to somatic items vary based on awareness of being evaluated for depressive symptoms. The study aims to clarify whether the ordering of questions impacts the reporting of symptoms that overlap with both depression and chronic illness. By understanding these dynamics, the research seeks to improve the accuracy of depression assessments in patients with systemic sclerosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of systemic sclerosis who can provide informed consent and are fluent in English, French, or Spanish.
Not a fit: Patients without systemic sclerosis or those unable to complete the questionnaire due to language barriers or lack of internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate depression assessments for patients with systemic sclerosis, improving their overall care.
How similar studies have performed: Previous studies have indicated that the context of questionnaire items does not significantly affect total depression scores, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English, French or Spanish. * Participants must have access to a computer or tablet with internet access. Exclusion Criteria: * None.
Where this trial is running
Montreal, Quebec and 1 other locations
- Jewish General Hospital — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
- Lady Davis Institute for Medical Research — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Brett D Thombs, PhD
- Email: brett.thombs@mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scleroderma, Systemic Sclerosis, Depression, Patient-reported outcome measure, PROM, Item order