|D012594||Scleroderma, Localized NIH||1.00|
|D012595||Scleroderma, Systemic NIH||1.00|
There is one clinical trial.
Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.
Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 Time: 4-weeks post-randomization
Description: PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.Measure: Depression symptoms: Patient Health Questionnaire (PHQ-8) Time: 4-weeks post-randomization
Description: The 10-item PSS measures the degree that respondents appraise their lives as stressful; items are designed to reflect the degree that they find their life circumstances in the last 4 weeks to be unpredictable, uncontrollable, or overloaded. Items are scored on a 5-point scale from 0 (never) to 4 (very often). Total scores (range 0 to 40) are computed by summing individual items scores, and higher scores reflect greater perceived stress. The PSS has been validated in many medical and non-medical populations.Measure: Stress: Perceived Stress Scale (PSS) Time: 4-weeks post-randomization
Description: The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18.Measure: Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) Time: 4-weeks post-randomization
Description: The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.Measure: Boredom: Multidimensional State Boredom Scale (MSBS-8) Time: 4-weeks post-randomization
Description: The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults.Measure: Physical activity: International Physical Activity Questionnaire - modified for the elderly (IPAQ-E) Time: 4-weeks post-randomization
Description: Frequency of social interactions with others inside and outside of the home will be measured with 4 separate items, including (1) On a typical day in the last week, how many times did you have a social conversation over the phone or a videoconferencing platform with one person? (response = number of times); (2) On a typical day in the last week, how many times did you have a social conversation over a videoconferencing platform with multiple people at the same time? (response = number of times); (3) In the last 7 days, on a typical day, how long did you spend enjoying conversations with other individuals in the home? (response = time); (4) In the last 7 days, on a typical day, how long did you spend enjoying activities with other individuals in the home? (response = time).Measure: Frequency of social interactions Time: 4-weeks post-randomization
Description: Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.Measure: Adverse Effects Time: 4-weeks post-randomization