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

NCT06772896 | Completed

• 1 other identifier: 2025-PHQ
• Study Type: interventional
• Target: 851
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Scleroderma; Systemic Sclerosis; Depression; Patient-reported outcome measure; PROM; Item order

Outcome Measures

Primary Outcomes (1)

• Difference in mean sum PHQ-8 somatic item scores when administered outside and within a depression questionnaire context

  Scores obtained on the 8-item Patient Health Questionnaire (PHQ-8) range from 0 to 24, with higher scores indicating worse outcome. Individual items are scored on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). PHQ-8 somatic items will include items 3 (sleep problems), 4 (fatigue), and 5 (changes in appetite). The investigators will compare the mean sum score of somatic item scores between the "Reordered items" arm and the "Original item order" arm using a between-groups t-test.

  At enrollment

Secondary Outcomes (1)

• Difference in individual PHQ-8 somatic item mean scores when administered outside and within a depression questionnaire context

  At enrollment

Study Arms (2)

Reordered items

EXPERIMENTAL

Participants will receive a routine assessment protocol in which the 3 PHQ-8 somatic items will be presented separately from and prior to the 5 psychological items, without any indication they are part of a depression symptom questionnaire. PHQ-8 psychological items will be presented after the somatic items and with at least 1 measure separating them in the routine assessment protocol. With the exception of these 2 rules, all measures included in the routine assessment will appear in a random order for each SPIN Cohort participant.

Other: Reordered PHQ-8

Original item order

NO INTERVENTION

Participants will complete the standard version of the PHQ-8 which includes both somatic and psychological items, presented in a random order among other measures of the routine assessment protocol. The title of the PHQ-8 will not be included and participants will only see the 8 items presented on a single page in their standard order.

Interventions

Reordered PHQ-8 OTHER

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

Reordered items

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Lady Davis Institute for Medical Research

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Depression

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: January 17, 2025
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-01

Locations

CA (2)