Use and perceptions of nutrition information resources in systemic sclerosis: a Scleroderma Patient-centred Intervention Network (SPIN) cohort study.

OBJECTIVES: People with systemic sclerosis (SSc) may find it challenging to obtain high-quality nutrition and diet information. Objectives were to evaluate (i) how commonly different information resources are used and (ii) perceived trustworthiness, accessibility, comprehensibility, and individualisation of resources. METHODS: We administered the Scleroderma Patient-centred Intervention Network Nutrition Information Resources Survey to participants in an international cohort. Participants were asked if they had used 26 informational resources in four categories, including (i) health care providers, (ii) websites or social media, (iii) print materials, and (iv) events, and to rate each resource on trustworthiness, accessibility, comprehensibility, and individualisation (0 = not at all to 10 = completely). RESULTS: 727 participants completed the survey. Most (94%) had sought nutrition or diet information from at least one resource. The most-used category was health care providers (86%), followed by print materials (68%), websites or social media (66%), and events (43%). People who had used a resource generally rated it more favourably across all domains than those who had not. The highest-rated resources across domains were conventional health care providers (doctors, registered dieticians, nurses), SSc patient organisations, SSc support groups, and university or research institution websites. CONCLUSIONS: Respondents used many different diet and nutrition information resources. They preferred resources from conventional health care providers, affiliated with credible institutions (e.g., SSc patient organisations), or with personal connections (e.g., SSc support groups). Future research should address the limited evidence base on nutrition in SSc and assess the quality of information provided by different information resources.

Factors associated with satisfaction with social roles and activities among people with systemic sclerosis: a Scleroderma Patient-centered Intervention Network (SPIN) cohort cross-sectional study.

OBJECTIVE: The objectives were to (1) compare satisfaction with social roles and activities in a large multinational systemic sclerosis (SSc) cohort to general population normative data and (2) identify sociodemographic, lifestyle and SSc disease factors associated with satisfaction with social roles and activities. METHODS: Participants in the Scleroderma Patient-centered Intervention Network Cohort completed the Patient Reported Outcomes Information System Version 2 satisfaction with social roles and activities domain questionnaire. Multivariable regression was used to assess associations with sociodemographic, lifestyle and disease factors. RESULTS: Among 2385 participants, mean satisfaction with social roles and activities T-score (48.1, SD=9.9) was slightly lower than the US general population (mean=50, SD=10). Factors independently associated with satisfaction were years of education (0.54 per SD, 95% CI 0.14 to 0.93); non-White race or ethnicity (-1.13, 95% CI -2.18 to -0.08); living in Canada (-1.33, 95% CI -2.40 to -0.26 (reference USA)) or the UK (-2.49, 95% CI -3.92 to -1.06); body mass index (-1.08 per SD, 95% CI -1.47 to -0.69); gastrointestinal involvement (-3.16, 95% CI -4.27 to -2.05); digital ulcers (-1.90, 95% CI -3.05 to -0.76); moderate (-1.62, 95% CI -2.78 to -0.45) or severe (-2.26, 95% CI -3.99 to -0.52) small joint contractures; interstitial lung disease (-1.11, 95% CI -1.97 to -0.25); pulmonary arterial hypertension (-2.69, 95% CI -4.08 to -1.30); rheumatoid arthritis (-2.51, 95% CI -4.28 to -0.73); and Sjogren's syndrome (-2.42, 95% CI -3.96 to -0.88). CONCLUSION: Mean satisfaction with social roles and activities is slightly lower in SSc than the general population and associated with multiple sociodemographic and disease factors.

Factors associated with physical function among people with systemic sclerosis: a SPIN cohort cross-sectional study.

OBJECTIVES: To compare physical function in systemic sclerosis (SSc, scleroderma) to general population normative data and identify associated factors. METHODS: Scleroderma Patient-centered Intervention Network Cohort participants completed the Physical Function domain of the Patient-Reported Outcomes Measurement Information System Version 2 upon enrolment. Multivariable linear regression was used to assess associations of sociodemographic, lifestyle, and disease-related variables. RESULTS: Among 2,385 participants, mean physical function T-score (43.7, SD = 8.9) was ∼2/3 of a standard deviation (SD) below the US general population (mean = 50, SD = 10). Factors associated in multivariable analysis included older age (-0.74 points per SD years, 95% CI -0.78 to -1.08), female sex (-1.35, -2.37 to -0.34), fewer years of education (-0.41 points per SD in years, -0.75 to -0.07), being single, divorced, or widowed (-0.76, -1.48 to -0.03), smoking (-3.14, -4.42 to -1.85), alcohol consumption (0.79 points per SD drinks per week, 0.45-1.14), BMI (-1.41 points per SD, -1.75 to -1.07), diffuse subtype (-1.43, -2.23 to -0.62), gastrointestinal involvement (-2.58, -3.53 to -1.62), digital ulcers (-1.96, -2.94 to -0.98), moderate (-1.94, -2.94 to -0.93) and severe (-1.76, -3.24 to -0.28) small joint contractures, moderate (-2.10, -3.44 to -0.76) and severe (-2.54, -4.64 to -0.44) large joint contractures, interstitial lung disease (-1.52, -2.27 to -0.77), pulmonary arterial hypertension (-3.72, -4.91 to -2.52), rheumatoid arthritis (-2.10, -3.64 to -0.56) and idiopathic inflammatory myositis (-2.10, -3.63 to -0.56). CONCLUSION: Physical function is impaired for many individuals with SSc and associated with multiple disease factors.

The association of resilience and positive mental health in systemic sclerosis: A Scleroderma Patient-centered Intervention Network (SPIN) cohort cross-sectional study.

OBJECTIVE: A previous study using Scleroderma Patient-centered Intervention Network (SPIN) Cohort data identified five classes of people with systemic sclerosis (also known as scleroderma) based on patient-reported somatic (fatigue, pain, sleep) and mental health (anxiety, depression) symptoms and compared indicators of disease severity between classes. Across four classes ("low", "normal", "high", "very high"), there were progressively worse somatic and mental health outcomes and greater disease severity. The fifth ("high/low") class, however, was characterized by high disease severity, fatigue, pain, and sleep but low mental health symptoms. We evaluated resilience across classes and compared resilience between classes. METHODS: Cross-sectional study. SPIN Cohort participants completed the 10-item Connor-Davidson-Resilience Scale (CD-RISC) and PROMIS v2.0 domains between August 2022 and January 2023. We used latent profile modeling to identify five classes as in the previous study and multiple linear regression to compare resilience levels across classes, controlling for sociodemographic and disease variables. RESULTS: Mean CD-RISC score (N = 1054 participants) was 27.7 (standard deviation = 7.3). Resilience decreased progressively across "low" to "normal" to "high" to "very high" classes (mean 4.7 points per step). Based on multiple regression, the "high/low" class exhibited higher resilience scores than the "high" class (6.0 points, 95% confidence interval [CI] 4.9 to 7.1 points; standardized mean difference = 0.83, 95% CI 0.67 to 0.98). CONCLUSIONS: People with worse disease severity and patient-reported outcomes reported substantially lower resilience, except a class of people with high disease severity, fatigue, pain, and sleep disturbance but positive mental health and high resilience.

Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial.

BACKGROUND: Online mindfulness based cognitive therapy (eMBCT) has been shown to reduce psychological distress in people with cancer. However, this population has reported lack of support and asynchronous communication as barriers to eMBCT, resulting in higher nonadherence rates than with face-to-face MBCT. Using a co-creation process, we developed 2 formats of eMBCT: group, blended (combination of therapist-guided group and individual online sessions) and individual, unguided (individual, unguided online sessions only). Group, blended eMBCT offers peer support and guidance, whereas individual, unguided eMBCT offers flexibility and the possibility of large-scale implementation. OBJECTIVE: The objective of this nonrandomized feasibility study was to assess aspects of feasibility of the group, blended and individual, unguided eMBCT interventions. METHODS: Participants were people with cancer who chose between group, blended and individual, unguided eMBCT. Both intervention conditions followed the same 8-week eMBCT program, including an introductory session and a silent day (10 sessions total). All sessions for individual, unguided eMBCT occurred via the platform Minddistrict, whereas group, blended eMBCT consisted of 3 online videoconference sessions guided by a mindfulness teacher and 5 sessions via Minddistrict. We assessed the feasibility of the intervention quantitatively and qualitatively by evaluating its acceptability among participants. Additionally, we assessed limited efficacy by looking at the number of questionnaires participants completed pre- and postintervention. RESULTS: We included 12 participants for each eMBCT condition. Participants in group, blended eMBCT completed, on average, 9.7 of 10 sessions, compared with an average 8.3 sessions for individual, unguided eMBCT (excluding dropouts). Of the 24 participants, 13 (54%) agreed to be interviewed (5 unguided and 8 blended). Participants in both conditions reported positive experiences, including the convenience of not having to travel and the flexibility to choose when and where to participate. However, among the barriers for participation, participants in the group, blended condition reported a preference for more group sessions, and participants in the individual, unguided condition reported a lack of guidance. Additionally, for the group, blended condition, the effect sizes were small for all outcome measures (Hedges g range=0.01-0.36), except for fatigue, which had a moderate effect size (Hedges g=0.57). For the individual, unguided condition, the effect sizes were small for all outcome measures (Hedges g range=0.24-0.46), except for mindfulness skills (Hedges g=0.52) and engagement with the intervention (Hedges g=1.53). CONCLUSIONS: Participants in this study had a positive experience with group, blended and individual, unguided eMBCT. Based on the results from this study, we will adjust the intervention prior to conducting a full-scale randomized controlled trial to evaluate effectiveness; we will add 1 group session to the group, blended eMBCT using Zoom as the platform for the group sessions; and we will send reminders to participants to complete questionnaires. TRIAL REGISTRATION: ClinicalTrials.gov NCT05336916; https://clinicaltrials.gov/ct2/show/NCT05336916.

Measurement equivalence of the English and French versions of the self-efficacy to manage chronic disease scale: a Scleroderma Patient-Centered Intervention Network (SPIN) study.

PURPOSE: The Self-Efficacy to Manage Chronic Disease (SEMCD) scale is widely used, including in systemic sclerosis (SSc). The SEMCD has been validated in SSc, but the metric equivalence of the English and French versions has not been assessed (i.e., whether psychometric properties are equivalent across English and French). METHODS: Participants were adults from the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort (N = 2159) who completed baseline measures in English (n = 1473) or French (n = 686) between May 2014 to July 2020. Analyses assessed internal consistency reliability via Cronbach's alpha and McDonald's omega, convergent validity via Pearson's correlations, structural validity via confirmatory factor analysis (CFA), and differential item functioning via the Multiple-Indicator Multiple-Cause (MIMIC) model. RESULTS: Internal consistency reliability was high in English (α = .93, ω = .93) and French (α = .92, ω = .93). All correlations between the SEMCD and measures of health outcomes were moderate to large, statistically significant, and in the hypothesized direction in both languages. The CFA demonstrated that the one-factor model of self-efficacy, overall, fit reasonably well (CFI = .96, TLI = .93, SRMR = .03, RMSEA = .14). Standardized factor loadings were large (.76 to .88). Three items displayed statistically significant uniform DIF and all six displayed nonuniform DIF; all DIF was of minimal magnitude. Comparison of unadjusted and DIF-adjusted models indicated that DIF did not meaningfully impact total score (ICC = 0.999, r = 0.999). CONCLUSION: Scores from English- and French-speaking adults with SSc can be combined for analysis or compared.

Moderators of Loneliness Trajectories in People with Systemic Sclerosis During the COVID-19 Pandemic: A SPIN COVID-19 Cohort Longitudinal Study.

BACKGROUND: Many individuals with systemic sclerosis (SSc) are at heightened risk for COVID-19 related morbidity and isolation due to interstitial lung disease, frailty, and immunosuppressant use. Minimal research has explored loneliness predictors in individuals with chronic illnesses during COVID-19. This study evaluated moderators of loneliness trajectories in individuals with SSc during COVID-19. METHODS: Longitudinal data were analyzed across 30 timepoints from April 2020 to May 2022 from 775 adults in the Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Cohort. Hierarchical linear modeling evaluated cross-level moderators of loneliness trajectories, including marital status, baseline number of household members, number of virtual or telephone one-on-one or virtual group conversations, number of hours spent enjoying in-person household conversations or activities, and satisfaction with quality of in-person household conversations (all in the past week). Level-1 moderation analyses assessed effects of conversation, activity, and satisfaction means and slopes over time. RESULTS: Baseline values were not statistically significant moderators of loneliness trajectories. Higher mean (averaged over time) virtual or telephone one-on-one and in-person household conversations, in-person household activity, and in-person household conversation satisfaction were associated with lower loneliness trajectories (ps < .05). The relationship between in-person household conversation satisfaction and loneliness trajectory was statistically significantly but minimally attenuated over time (p < .001). CONCLUSIONS: For people with SSc, higher mean conversation, activity, and satisfaction variables were associated with lower levels of loneliness during the pandemic, but changes in these social variables were generally not predictive of changes in loneliness.

A qualitative interview study exploring the psychological health impacts of the SPIN-CHAT program among people with systemic sclerosis at the onset of COVID-19: perceptions of trial participants and research team members.

PURPOSE: Explore trial participants' and research team members' perceptions of the impact of the videoconference-based, supportive care program (SPIN-CHAT Program) during early COVID-19 for individuals with systemic sclerosis (SSc). METHODS: Data were collected cross-sectionally. A social constructivist paradigm was adopted, and one-on-one videoconference-based, semi-structured interviews were conducted with SPIN-CHAT Trial participants and research team members. A hybrid inductive-deductive approach and reflexive thematic analysis were used. RESULTS: Of the 40 SPIN-CHAT Trial participants and 28 research team members approached, 30 trial participants (Mean age = 54.9; SD = 13.0 years) and 22 research team members agreed to participate. Those who took part in interviews had similar characteristics to those who declined. Five themes were identified: (1) The SPIN-CHAT Program conferred a range of positive psychological health outcomes, (2) People who don't have SSc don't get it: The importance of SSc-specific programming, (3) The group-based format of the SPIN-CHAT Program created a safe space to connect and meet similar others, (4) The structure and schedule of the SPIN-CHAT Program reduced feelings of boredom and contributed to enhanced psychological health, (5) The necessity of knowledge, skills, and tools to self-manage SSc and navigate COVID-19. CONCLUSION: Participants' and research team members' perspectives elucidated SPIN-CHAT Program benefits and how these benefits may have been realized. Results underscore the importance of social support from similar others, structure, and self-management to enhance psychological health during COVID-19. TRIAL REGISTRATION: clinicaltrials.gov (NCT04335279)IMPLICATIONS FOR REHABILITATIONThe videoconference-based, supportive care SPIN-CHAT Program enhanced psychological health amongst individuals affected by systemic sclerosis.SPIN-CHAT Program participants and research team members shared that being around similar others, program structure, and self-management support were important and may have contributed to enhanced psychological health.Further efforts are required to explore experiences within supportive care programs to better understand if and how psychological health is impacted.

Randomized controlled trial of an individual blended cognitive behavioral therapy to reduce psychological distress among distressed colorectal cancer survivors: The COloRectal canceR distrEss reduCTion trial.

OBJECTIVE: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. METHODS: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face-to-face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention-to-treat population was distress severity (Brief Symptom Inventory; BSI-18) immediately post-intervention (T1). RESULTS: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention-to-treat analysis, the intervention significantly reduced distress immediately post-intervention (-3.86 points, 95% CI -7.00 to -0.73) and at 7 months post-randomization (-3.88 points, 95% CI -6.95 to -0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer-specific distress were significantly lower in the intervention arm. Self-efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. CONCLUSIONS: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR6025.

Support and information needs of people with systemic sclerosis by time since diagnosis: A cross-sectional study.

Background: How support and informational needs of people with systemic sclerosis (SSc) may differ by time since diagnosis is not known. Our objective was to determine if informational and support needs of recently diagnosed individuals with systemic sclerosis differ from people diagnosed for longer periods of time. Methods: The North American Scleroderma Support Group Members survey included 30 items on reasons for attending support groups. Respondents were classified by time since diagnosis of 0-3 years, 4-9 years or 10+ years. Survey item responses were dichotomized into Not Important or Somewhat Important versus Important or Very Important. We conducted Chi-square tests with Hochberg's Sequential Method to identify item differences by time since diagnosis. Results: A total of 175 respondents completed the survey. Most support needs were rated as Important or Very Important by respondents, regardless of disease duration, particularly needs related to interpersonal and social support (10 items; median 81%) and learning about disease treatment and management strategies (11 items; median 82%). Discussing other aspects of living with systemic sclerosis (e.g. spirituality, discussing disease with family and friends) was rated lower (9 items; 44%). Respondents with 0-3 years since diagnosis were the highest on 29 of 30 items. Respondents with 0-3 years since diagnosis were significantly higher on items related to discussing medical care and 4 items on other aspects (spirituality, talking with family and friends, financial issues, sexual issues). Conclusion: People with systemic sclerosis have a wide range of information and support needs, regardless of their disease duration, but people with recent diagnoses have greater needs.

Patterns of patient-reported symptoms and association with sociodemographic and systemic sclerosis disease characteristics: a scleroderma Patient-centered Intervention Network (SPIN) Cohort cross-sectional study.

Background: Systemic sclerosis is a heterogenous disease in which little is known about patterns of patient-reported symptom clusters. We aimed to identify classes of individuals with similar anxiety, depression, fatigue, sleep disturbance, and pain symptoms and to evaluate associated sociodemographic and disease-related characteristics. Methods: This multi-centre cross-sectional study used baseline data from Scleroderma Patient-centered Intervention Network Cohort participants enrolled from 2014 to 2020. Eligible participants completed the PROMIS-29 v2.0 measure. Latent profile analysis was used to identify homogeneous classes of participants based on patterns of anxiety, depression, fatigue, sleep disturbance, and pain scores. Sociodemographic and disease-related characteristics were compared across classes. Findings: Among 2212 participants, we identified five classes, including four classes with "Low" (565 participants, 26%), "Normal" (651 participants, 29%), "High" (569 participants, 26%), or "Very High" (193 participants, 9%) symptom levels across all symptoms. Participants in a fifth class, "High Fatigue/Sleep/Pain and Low Anxiety/Depression" (234 participants, 11%) had similar levels of fatigue, sleep disturbance, and pain as in the "High" class but low anxiety and depression symptoms. There were significant and substantive trends in sociodemographic characteristics (age, education, race or ethnicity, marital or partner status) and increasing disease severity (diffuse disease, tendon friction rubs, joint contractures, gastrointestinal symptoms) across severity-based classes. Disease severity and sociodemographic characteristics of "High Fatigue/Sleep/Pain and Low Anxiety/Depression" class participants were similar to the "High" severity class. Interpretation: Most people with systemic sclerosis can be classified by levels of patient-reported symptoms, which are consistent across symptoms and highly associated with sociodemographic and disease-related variables, except for one group which reports low mental health symptoms despite high levels of other symptoms and substantial disease burden. Studies are needed to better understand resilience in systemic sclerosis and to identify and facilitate implementation of cognitive and behavioural strategies to improve coping and overall quality of life. Funding: National Institute of Nursing Research (F31NR019007), Canadian Institutes of Health Research, Arthritis Society Canada, the Lady Davis Institute for Medical Research, the Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

Differential Item Functioning on the Cochin Hand Function Scale Among People With Systemic Sclerosis by Language, Sex, and Disease Subtype: A Scleroderma Patient-Centered Intervention Network (SPIN) Cohort Study.

OBJECTIVE: To evaluate the degree that the Cochin Hand Function Scale (CHFS) generates scores that are comparable across language, sex, and disease subtype. METHODS: We included participants enrolled in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort who completed the CHFS at their baseline assessment between April 2014 and September 2020. Confirmatory factor analysis (CFA) was used to test unidimensionality, and multiple indicator multiple cause (MIMIC) models were used for differential item functioning (DIF) analysis based on language, sex, and disease subtype. Both intraclass correlation coefficient (ICC) and Pearson's correlation were calculated using factor scores obtained from unadjusted and DIF-adjusted MIMIC models to evaluate agreement and correlation between scores. RESULTS: A total of 2,155 participants were included. CFA with covarying error terms supported a good fit of the model (χ2 [127] = 1,754.671; P < 0.001; Tucker-Lewis index = 0.985; comparative fit index = 0.987; root mean square error of approximation = 0.077). Nine items displayed statistically significant DIF for language of administration, 10 items for sex, and 10 items for disease subtype. However, the overall impact of DIF was negligible when comparing factor scores that did and did not account for DIF (ICC = 0.999; r = 0.999). CONCLUSION: The CHFS has score comparability in systemic sclerosis regardless of participants' language, sex, and disease subtype.

Validity, Reliability, and Differential Item Functioning of English and French Versions of the 10-Item Connor-Davidson Resilience Scale in Systemic Sclerosis: A Scleroderma Patient-Centered Intervention Network Cohort Study.

OBJECTIVE: Some individuals with systemic sclerosis (SSc) report positive mental health, despite severe disease manifestations, which may be associated with resilience, but no resilience measure has been validated in SSc. This study was undertaken to assess the validity, reliability, and differential item functioning (DIF) between English- and French-language versions of the 10-item Connor-Davidson Resilience Scale (CD-RISC-10) in SSc. METHODS: Eligible participants were enrolled in the Scleroderma Patient-centered Intervention Network Cohort and completed the CD-RISC-10 between August 2022 and January 2023. We used confirmatory factor analysis (CFA) to evaluate the CD-RISC-10 factor structure and conducted DIF analysis across languages with Multiple Indicators Multiple Causes models. We tested convergent validity with another measure of resilience and measures of self-esteem and depression and anxiety symptoms. We assessed internal consistency and test-retest reliability using Cronbach's alpha and intraclass correlation coefficient (ICC). RESULTS: A total of 962 participants were included in this analysis. CFA supported a single-factor structure (Tucker-Lewis index = 0.99, comparative fit index = 0.99, root mean square error of approximation = 0.08 [90% confidence interval (90% CI) 0.07, 0.09]). We found no meaningful DIF. Internal consistency was high (α = 0.93 [95% CI 0.92, 0.94]), and we found that correlations with other measures of psychological functioning were moderate to large (|r| = 0.57-0.78) and confirmed study hypotheses. The scale showed good 1-2-week test-retest reliability (ICC 0.80 [95% CI 0.75, 0.85]) in a subsample of 230 participants. CONCLUSION: The CD-RISC-10 is a valid and reliable measure of resilience in SSc, with score comparability across English and French versions.

Mental health symptoms in scleroderma during COVID-19: a Scleroderma Patient-centred Intervention Network (SPIN) cohort longitudinal study.

OBJECTIVES: People with systemic sclerosis (SSc) are vulnerable in COVID-19 and face challenges related to shifting COVID-19 risk and protective restrictions. We evaluated mental health symptom trajectories in people with SSc through March 2022. METHODS: The longitudinal Scleroderma Patient-centred Intervention Network (SPIN) COVID-19 cohort was launched in April 2020 and included participants from the ongoing SPIN Cohort and external enrolees. Analyses included estimated means with 95% CIs for anxiety and depression symptoms pre-COVID-19 for ongoing SPIN Cohort participants and anxiety, depression, loneliness, and fear of COVID-19 for all participants across 28 COVID-19 assessments up to March 2022. We conducted sensitivity analyse including estimating trajectories using only responses from participants who completed >90% of items for ≥21 of 28 possible assessments ("completers") and stratified analyses for all outcomes by sex, age, country, and SSc subtype. RESULTS: Anxiety symptoms increased in early 2020 but returned to pre-COVID-19 levels by mid-2020 and remained stable through March 2022. Depression symptoms did not initially change but were slightly lower by mid-2020 compared to pre-COVID-19 and were stable through March 2022. COVID-19 fear started high and decreased. Loneliness did not change across the pandemic. Results were similar for completers and for all subgroups. CONCLUSIONS: People with SSc continue to face COVID-19 challenges related to ongoing risk, the opening of societies, and removal of protective restrictions. People with SSc, in aggregate, appear to be weathering the pandemic well, but health care providers should be mindful that some individuals may benefit from mental health support.

Evaluation of Measurement Properties and Differential Item Functioning in the English and French Versions of the University of California, Los Angeles, Loneliness Scale-6: A Scleroderma Patient-Centered Intervention Network (SPIN) Study.

OBJECTIVE: Loneliness has been associated with poorer health-related quality of life but has not been studied in patients with systemic sclerosis (SSc). The current study was undertaken to examine and compare the psychometric properties of the English and French versions of the University of California, Los Angeles, Loneliness Scale-6 (ULS-6) in patients with SSc during the COVID-19 pandemic. METHODS: This study used baseline cross-sectional data from 775 adults enrolled in the Scleroderma Patient-Centered Intervention Network (SPIN) COVID-19 Cohort. Reliability and validity of ULS-6 scores overall and between languages were evaluated using confirmatory factor analysis (CFA), differential item functioning (DIF) through the multiple-indicator multiple-cause (MIMIC) model, omega/alpha calculation, and correlations of hypothesized convergent relationships. RESULTS: CFA for the total sample supported the single-factor structure (comparative fit index [CFI] 0.96, standardized root mean residual [SRMR] 0.03), and all standardized factor loadings for items were large (0.60-0.86). The overall MIMIC model with language as a covariate fit well (CFI 0.94, SRMR 0.04, root mean square error of approximation 0.11). Statistically significant DIF was found for 3 items across language (ßitem2  = 0.14, P < 0.001; ßitem4  = -0.07, P = 0.01; ßitem6  = 0.13, P < 0.001), but these small differences were without practical measurement implications. Analyses demonstrated high internal consistency with no language-based convergent validity differences. CONCLUSION: Analyses demonstrated evidence of acceptable reliability and validity of ULS-6 scores in English- and French-speaking adults with SSc. DIF analysis supported use of the ULS-6 to examine comparative experiences of loneliness without adjusting for language.

Exploring research team members' and trial participants' perceptions of acceptability and implementation within one videoconference-based supportive care program for individuals affected by systemic sclerosis during COVID-19: a qualitative interview study.

The SPIN-CHAT Program was designed to support mental health among individuals with systemic sclerosis (SSc; commonly known as scleroderma) and at least mild anxiety symptoms at the onset of COVID-19. The program was formally evaluated in the SPIN-CHAT Trial. Little is known about program and trial acceptability, and factors impacting implementation from the perspectives of research team members and trial participants. Thus, the propose of this follow-up study was to explore research team members' and trial participants' experiences with the program and trial to identify factors impacting acceptability and successful implementation. Data were collected cross-sectionally through one-on-one, videoconference-based, semi-structured interviews with 22 research team members and 30 purposefully recruited trial participants (Mage = 54.9, SD = 13.0 years). A social constructivist paradigm was adopted, and data were analyzed thematically. Data were organized into seven themes: (i) getting started: the importance of prolonged engagement and exceeding expectations; (ii) designing the program and trial: including multiple features; (iii) training: research team members are critical to positive program and trial experiences; (iv) offering the program and trial: it needs to be flexible and patient-oriented; (v) maximizing engagement: navigating and managing group dynamics; (vi) delivering a videoconference-based supportive care intervention: necessary, appreciated, and associated with some barriers; and (vii) refining the program and trial: considering modification when offered beyond the period of COVID-19 restrictions. Trial participants were satisfied with and found the SPIN-CHAT Program and Trial to be acceptable. Results offer implementation data that can guide the design, development, and refinement of other supportive care programs seeking to promote psychological health during and beyond COVID-19.

The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program, a videoconference-based supportive care program, was designed to protect and enhance mental health in individuals affected by systemic sclerosis (commonly known as scleroderma) with at least mild anxiety symptoms during the COVID-19 pandemic. A trial was conducted to evaluate the SPIN-CHAT Program, and results were generally positive. However, important gaps in knowledge remained. Specifically, research team members' and participants' perceptions of SPIN-CHAT Trial acceptability (including satisfaction) and factors impacting implementation of the SPIN-CHAT Program had not yet been explored. To fill this gap, we conducted one-on-one, videoconference-based, semi-structured interviewed with 22 research team members and 30 purposefully recruited trial participants. Interviews sought to gain insights into research team members' and trial participants' experiences within the SPIN-CHAT Program, delivery preferences, and aspects that were/were not beneficial. Findings suggest research team members and participants valued the SPIN-CHAT Program and found the trial to be acceptable. Results also highlight important factors to consider when designing, developing, and/or refining videoconference-based supportive care programs.

Differences in Disability Perception in Systemic Sclerosis: A Mirror Survey of Patients and Health Care Providers.

Differences in disability perception between patients and care providers may impact outcomes. We aimed to explore differences in disability perception between patients and care providers in systemic sclerosis (SSc). We conducted a cross-sectional internet-based mirror survey. SSc patients participating in the online SPIN Cohort and care providers affiliated with 15 scientific societies were surveyed using the Cochin Scleroderma International Classification of Functioning, Disability and Health (ICF)-65 questionnaire, including 65 items (from 0 to 10), representing 9 domains of disability. Mean differences between patients and care providers were calculated. Care providers' characteristics associated with a mean difference ≥ 2 of 10 points were assessed in multivariate analysis. Answers were analyzed for 109 patients and 105 care providers. The mean age of patients was 55.9 (14.7) years and the disease duration was 10.1 (7.5) years. For all domains of the ICF-65, care providers' rates were higher than those of patients. The mean difference was 2.4 (1.0) of 10 points. Care providers' characteristics associated with this difference were organ-based specialty (OR = 7.0 [2.3-21.2]), younger age (OR = 2.7 [1.0-7.1]) and following patients with disease duration ≥5 years (OR = 3.0 [1.1-8.7]). We found systematic differences in disability perception between patients and care providers in SSc.

'Everybody is watching me': A closer look at anxiety in people with facial palsy.

OBJECTIVES: Objectives were to evaluate the sociodemographic and disease-related factors, and coping style associated with social interaction and social appearance anxiety in people with unilateral facial palsy. METHODS: Medical data were extracted from electronic health records, and participants completed the Social Interaction Anxiety Scale (SIAS), Social Appearance Anxiety Scale (SAAS), and Coping Orientation to Problems Experienced inventory. Associations of SIAS and SAAS scores with sociodemographic and disease variables, and coping were assessed with multiple linear regression. RESULTS: Among 111 participants (mean age 58.6 years; 59% women), higher age and greater use of emotion-focused coping were associated with lower SIAS scores, whereas greater use of avoidant coping was associated with higher SIAS scores. Higher age, male sex, and greater use of emotion-focused coping were associated with lower SAAS scores, whereas greater use of avoidant coping was associated with higher SAAS scores. CONCLUSIONS: Healthcare providers should understand that women and younger people are more likely to have social appearance concerns and that this is not predicted by the objective severity of facial palsy.

Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial.

BACKGROUND: One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. METHODS: The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. DISCUSSION: There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 .