Questionnaire Context for Scleroderma

No longer recruiting at 1 trial location

Overseen By Brett D Thombs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with systemic sclerosis (a chronic disease that causes hardening of the skin and connective tissues) respond to depression questionnaires. Researchers aim to determine if these individuals answer questions about physical symptoms differently when mixed with psychological ones. Participants will complete a depression questionnaire, the Reordered PHQ-8, either in the usual order or with physical symptom questions first. The trial seeks individuals diagnosed with systemic sclerosis who can use a computer or tablet and speak English, French, or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to understanding how systemic sclerosis affects mental health assessments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research has shown that the PHQ-8 questionnaire, even when rearranged, remains safe for participants. This tool assesses mental health, particularly depression, and has proven effective in various situations, including for individuals with systemic sclerosis.

Studies indicate that participants generally handle the PHQ-8 well, experiencing no negative effects. The questionnaire involves answering questions about feelings and physical symptoms. To date, there have been no reports of harm or discomfort from using the PHQ-8 in either its original or rearranged form.

This method, which involves answering questions, is non-invasive. It does not involve any drugs or physical procedures, ensuring a high level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of using the PHQ-8 questionnaire for people with scleroderma. Unlike standard treatments that primarily address the physical and psychological symptoms of scleroderma through medication, this trial aims to refine how symptoms are assessed. By presenting the somatic and psychological items of the PHQ-8 in a reordered format, researchers hope to better distinguish between physical and psychological symptoms without bias. This could lead to more accurate assessments and ultimately improve how treatments are tailored to individual patients.

What evidence suggests that this trial's protocol could be effective for assessing depression in people with systemic sclerosis?

Research has shown that physical symptoms in depression questionnaires don't significantly alter overall depression scores for people with systemic sclerosis. This suggests that the order of questions might not impact the results. However, the reasons for this remain unclear. In this trial, participants will join different arms to test the reordered PHQ-8 questionnaire. One arm will receive the reordered version, with physical symptoms asked about first, to see if this changes responses. Studies on patient-reported outcomes in systemic sclerosis enhance understanding of patients' quality of life and mental health. Understanding how question order affects responses can improve the accuracy of these assessments. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with systemic sclerosis, a chronic disease that can cause hardening and tightening of the skin and connective tissues. Participants should be able to complete a depression questionnaire as part of their routine assessments.

Inclusion Criteria

Participants must have access to a computer or tablet with internet access

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Randomization

Participants are enrolled and randomized to either the 'Reordered items' arm or the 'Original item order' arm

At enrollment

1 visit (virtual)

Assessment

Participants complete the PHQ-8 questionnaire with either reordered or original item order

At enrollment

1 visit (virtual)

Follow-up

Participants are monitored for differences in PHQ-8 somatic item scores

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Reordered PHQ-8

Trial Overview The study tests if changing the order of questions in the PHQ-8, a depression questionnaire, affects how people with systemic sclerosis report somatic (physical) symptoms. Some will answer questions in standard order; others start with somatic items.

How Is the Trial Designed?

Group I: Reordered items Experimental Treatment 1 Intervention

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.

Group II: Original item order Active Control 1 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.

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Published Research Related to This Trial

A systematic review of 93 randomized controlled trials involving 31,023 patients revealed a total of 21,498 adverse events (AEs), with 58% of these AEs being suitable for self-reporting by patients, highlighting the importance of patient perspectives in understanding treatment harms.

The study found a lack of systematic reporting on the severity of AEs, with only 9% of trials providing discernible severity grading, indicating a need for standardized frameworks to improve harm reporting in rheumatology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. Berthelsen, DB., Woodworth, TG., Goel, N., et al.[2021]

The study aims to create a dedicated module within the Hellenic Registry of Biologic Therapies to monitor Systemic Lupus Erythematosus (SLE) patients, focusing on disease activity, severity, and treatment outcomes, which will help assess the long-term efficacy and safety of biologic therapies like belimumab.

Registry-based studies allow for the inclusion of a broader patient population and long-term data collection, which can identify which disease phenotypes respond best to treatments and how co-existing conditions affect therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Pilot Registry for Monitoring the Efficacy and Safety of Novel Therapies in Patients with Systemic Lupus Erythematosus. Adamichou, C., Flouri, I., Fanouriakis, A., et al.[2020]

The study provided minimally important difference (MID) estimates for the UCLA SCTC GIT 2.0 scales in 115 patients with systemic sclerosis, helping to quantify meaningful changes in gastrointestinal symptoms over a 6-month period.

The MID estimates for improvement varied across scales, with the Emotional Well-being scale showing the largest improvement threshold (0.36), while the Fecal Soilage scale had the lowest worsening threshold (0.06), indicating different sensitivities of the scales to changes in health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. Khanna, D., Furst, DE., Maranian, P., et al.[2021]

The DANBIO database captured 20 times more adverse events related to biological agents than the Danish Medicines Agency, highlighting its effectiveness in monitoring patient safety.

Infections and hypersensitivity reactions were the most common adverse events, with older age, longer disease duration, and a higher number of previous DMARD treatments identified as risk factors for bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Hetland, ML., Unkerskov, J., Ravn, T., et al.[2019]

Long-term safety and effectiveness of TNF-alpha inhibitors are being monitored through independent, academia-initiated drug registers in several European countries, which include all licensed biological agents and utilize standardized reporting systems for adverse events.

These registers have identified key safety concerns related to infections, malignancies, cardiovascular events, and pregnancy outcomes, highlighting the importance of ongoing collaboration between regulatory authorities, academia, and pharmaceutical companies for effective pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European biologicals registers: methodology, selected results and perspectives. Zink, A., Askling, J., Dixon, WG., et al.[2013]

Citations

1. withpower.com withpower.com/trial/questionnaire-context-for-scleroderma-8a652

Questionnaire Context for Scleroderma · Info for Participants This N/A medical study run by Lady Davis Institute needs participants to evaluate whether Reordered PHQ-8 will have tolerable side effects & efficacy for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40643579/

Patient-reported outcomes in systemic sclerosis: insights ... Patient-reported outcomes in systemic sclerosis: insights into quality of life and disease burden ... efficacy of future interventions. Keywords: ...

3. researchgate.net researchgate.net/publication/345676127_An_Update_of_Outcome_Measures_in_Systemic_Sclerosis

An Update of Outcome Measures in Systemic Sclerosis 8 Many studies evaluate differences or changes in SSc-related disability, function, and mental health based on statistical significance, which ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8922614/

Patient-reported outcome instruments in clinical trials of ... This review considers the role and performance of the various patient-reported outcome instruments utilized in systemic sclerosis clinical trials.

5. storage.prod.researchhub.com storage.prod.researchhub.com/uploads/papers/2023/11/20/qt22b2g2fw.pdftrx8sud.pdf

UC Irvine Objective: The aim of this study is to examine validity, reliability, and responsiveness to change of Patient-Reported. Outcomes Measurement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9109504/

Reliability, validity, and responsiveness to change of the ... The aim of this study is to examine validity, reliability, and responsiveness to change of Patient-Reported Outcomes Measurement Information System ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9374049/

Mental Health Care Use and Associated Factors in ... The PHQ‐8 is derived from the nine‐item Patient Health Questionnaire (PHQ‐9), which is validated in SSc (13). A large individual participant ...