Clinical trial NCT04335279: Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program
Official title: A Partially Nested RCT to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety Among At-Risk Scleroderma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Scleroderma, Systemic
Systemic Sclerosis
Keywords: Scleroderma
Systemic Sclerosis
COVID-19
E-health
Anxiety
Mental health
Trial
Coronavirus
RCT
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Background: Social distancing and movement restrictions during contagious disease outbreaks are necessary to reduce spread but can lead to negative social and psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations. An online survey that used snowball sampling techniques and collected data from 1210 respondents from 194 cities in China in January-February 2020 found that over 50% rated the psychological impact of the coronavirus disease 2019 (COVID-19) outbreak as moderate or severe. Symptoms of anxiety were rated as the most common psychological problem. Self-reported poor physical health status and the presence of a chronic illness were associated with symptoms of depression and anxiety.

Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Onset typically occurs between the ages of 30 and 50 years, and approximately 80% of people with SSc are women. SSc can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Disease presentation is extremely heterogeneous, and the course of the disease is highly unpredictable. People with SSc commonly experience hand function and mobility limitations, pain, fatigue, sleep problems, pruritus, symptoms of depression, and body image distress from disfiguring aspects (e.g., skin tightening, pigment changes, hand contractures, telangiectasias). Many people with SSc 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 Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program is a group videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with SSc at risk of poor mental health during the COVID-19 pandemic. The primary objective of the SPIN-CHAT Trial is to evaluate the effect of the program compared to waitlist control on patient reported symptoms of anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 scores.

Recruitment and Enrolment: SPIN is a collaboration of SSc researchers, health care providers, people living with SSc, and patient organizations from Canada, the United States, Europe, Mexico and Australia that has assembled a large multinational patient cohort to collect longitudinal data on patient-reported outcomes in SSc and as a framework for embedding RCTs of e-health interventions. SPIN Cohort participants complete online assessments upon enrolment and at 3-month intervals. To date, over 2000 SSc patients from 47 centres have been enrolled in SPIN's web-based cohort (currently approximately 1800 active participants).

SPIN Cohort participants will be invited by email and by popups to enrol in the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Additionally, recruitment announcements for the SPIN-COVID-19 Cohort will be posted on SPIN's social media and distributed through our patient organization partners. All SPIN-COVID-19 Cohort participants will be invited to complete measures at baseline and every two weeks for the duration of the COVID-19 pandemic. They will receive email reminders to complete bi-weekly follow-up assessments.

Participants in the SPIN-COVID-19 Cohort eligible for the SPIN-CHAT Trial will be provided with a brief description of the trial in the SPIN-COVID-19 Qualtrics platform and will be asked if they would be interested in participating in the trial. Those who express interest will be provided with an online version of the trial consent form, which they can also download, and will be given the options of (1) consenting to participate; (2) declining participation; or (3) requesting that a member of SPIN's research team call them to answer questions they have about participating in the trial before consenting.

Methods: The SPIN-CHAT Trial is a pragmatic, two-arm partially nested RCT (PN-RCT) that will be conducted using the SPIN-COVID-19 Cohort. Pragmatic RCTs are conducted to replicate real-world delivery of interventions as much as possible and support decisions on whether interventions should be provided in practice. The trial will be a PN-RCT because participants randomised to the intervention arm will be clustered into intervention groups, and members of each intervention group will interact during videoconference sessions; participants randomly assigned to the waitlist control will not be clustered and will only complete trial measures.

Random Selection and Allocation: SPIN-COVID-19 Cohort participants who provide consent for participation will be entered into different pools based on their availabilities and taking into consideration time zone differences. Once there are enough participants to complete an intervention group and assign an equal number of participants to waitlist control, SPIN personnel will provide the external service with an anonymised list of participants (only identification numbers will be provided) who could participate in an intervention group based on language and day and time availabilities. For each intervention group and waitlist control pairing, the service will randomly select 16 participants from the pool of enroled participants available based on language, day, and time and will randomly allocate 8 to the intervention group and 8 to the waitlist group using block randomization.This process will be repeated until trial enrolment is complete. One intervention and waitlist control pairing will include 18 participants (9 intervention, 9 waitlist) to accommodate the total number that we anticipate randomizing.

Intervention and Comparator: Mental health outcomes, including anxiety, among people in quarantine are associated with modifiable factors such as degree of isolation, boredom, and ability to manage worry and anxiety. In addition to psychological strategies, including worry reduction and meditative exercises, exercise has been shown to reduce anxiety. Among older adults, where isolation is a common challenge, activity and social engagement are commonly used to address loneliness and feelings of isolation. Recommendations for the World Health Organization and major national public health organizations for managing mental health during COVID-19 emphasize setting and following a routine, managing information sources and quantity, staying connected with others, and finding a way to be physically active.

The SPIN-CHAT Program is a brief group videoconference intervention that was developed based on best-practice principles for managing anxiety and worry, recommendations for maintaining mental health during COVID-19, and input from the SPIN COVID-19 Patient Advisory Team. Educational segments in each session will be delivered by a research team member with experience and training related to the topic. Leisure activities that will be done at the start of each session will include games (e.g., Pictionary, charades), creative activities (e.g., roll-a-story), cultural activities (e.g., virtual museum tours), social activities (e.g., share your favourite recipe). In the healthy information management and social connection segment, strategies will be provided and discussion will be facilitated on how to stay informed via accurate information sources while avoiding sensationalist and other non-helpful information. Information on using simple (e.g., phone) or more advanced technology (e.g., group videoconferencing) to stay connected will be discussed, along with strategies for connecting regularly with others. The managing worry segments will include an overview of worry, including what it is, the difference between helpful and harmful anxiety or worry, how to identify triggers of worry, and strategies to manage worry, including identifying different types of worrying, using worry journals, worry postponement, and worry time. Exercises will be done with the group to illustrate techniques. In the relaxation segments, an introduction to the purpose of relaxation techniques will be presented, and participants will be guided through brief breathing, mindfulness, and visualization exercises.

The physical activity segments will include an overview of the physical and psychosocial benefits of physical activity for maintenance of health for chronic disease management, including mental health during the COVID-19 pandemic; movement guidelines to ensure safety; and how to monitor daily physical activity. Participants will be guided through movement options for the home-based setting, including warm-ups, aerobic, and strength activities. Behaviour change techniques to foster building the habit of moving more at home will be taught, including goal-setting, scheduling, addressing barriers, and building social support.

Activity engagement sessions will be guided by the leisure education content model. Sessions will involve interactive group discussion about the benefits of leisure engagement for persons with SSc, addressing physical, social, emotional, intellectual and spiritual realms of health and wellbeing. Sessions will explore barriers to leisure for persons with SSc and includes tips for finding leisure resources within the participants' own homes, both in-person and online.

Sample Size: Effects of short anxiety-focused interventions in post-disaster settings are between 0.40 and 0.80 standardized mean difference (SMD). This is larger than estimated minimally important difference for the PROMIS Anxiety 4a v1.0 score (SMD = 0.23 to 0.34 SMD). For an assumed effect size of SMD = 0.50, a two-tailed test with alpha = 0.05, and an intra-class correlation coefficient (ICC) of 0.05, N=146 provides 80% power or greater for our primary outcome, PROMIS Anxiety 4a v1.0; assuming 10% dropout, we will recruit 162 participants (81 in 10 SPIN-CHAT groups; 81 waitlist). We believe that this is a conservative power and sample size estimate. First, in cluster RCTs, ICC values for individual patient outcomes are typically lower than our 0.05 estimate. If the true ICC is lower than our 0.05 estimate, this will result in greater power than estimated. Second, there has been no loss to follow-up in the feasibility trial or initial waves of our full-scale trial of the videoconference-based SPIN support group leader program, which has a similar design. Thus, we believe that a 10% loss to follow-up may be conservative.

Data Analysis: Analyses will be conducted by a statistician blind to trial arm allocation. For the primary outcome analysis, we will use an intent-to-treat analysis that compares all patients randomly assigned to the SPIN-CHAT Program to all patients assigned to the waitlist control. The intervention effect at 4 weeks will be estimated using a linear mixed model, adjusted for baseline PROMIS Anxiety 4a v1.0 scores. The model will include a random effect to account for clustering of participants in the training groups, but not for participants in the waitlist control arm, because there is no clustering in the control arm. We will investigate the effects of missing data using multiple imputation. As a secondary analysis, we will additionally adjust for age, sex, baseline loneliness, baseline boredom, and baseline physical activity. Analyses of secondary outcomes will similarly be done (1) controlling for baseline scores only and (2) controlling for baseline scores, age, sex, and other key baseline measures. Statistical significance for all analyses will be determined based on two-sided α = 0.05. In addition, we will use complier-average causal effect analysis to estimate effects among patients who use the intervention compared to similar patients in the waitlist arm of the trial.

Eligibility criteria: Inclusion Criteria:

* Classified as having SSc by a physician
* PROMIS Anxiety 4a v1.0 T-score greater than or equal to 55
* Have regular, reliable internet access
* Be fluent in English or French

Exclusion Criteria:

* Receiving counseling or therapy currently
* Having a positive test for the COVID-19 virus

Primary outcomes:
measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0
timeFrame: 4-weeks post-randomization
Secondary outcomes:
measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0
timeFrame: 10-weeks post-randomization
measure: Depression Symptoms: Patient Health Questionnaire (PHQ-8)
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
measure: Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6)
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
measure: Boredom: Multidimensional State Boredom Scale (MSBS-8)
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
measure: Physical Activity: International Physical Activity Questionnaire - Modified for the Elderly (IPAQ-E)
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
measure: Adverse Effects
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
measure: Fear: COVID-19 Fears Questionnaire for Chronic Medical Conditions
timeFrame: 4-weeks post-randomization, 10-weeks post-randomization
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute, Sir Mortimer B. Davis Jewish General Hospital, McGill University
name: Brett D Thombs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thombs BD, Kwakkenbos L, Levis B, Bourgeault A, Henry RS, Levis AW, Harb S, Tao L, Carrier ME, Bustamante L, Duchek D, Dyas L, El-Baalbaki G, Ellis K, Rice DB, Wurz A, Nordlund J, Gagarine M, Turner KA, Ostbo N, Culos-Reed N, Hebblethwaite S, Patten S, Bartlett SJ, Varga J, Mouthon L, Markham S, Martin MS, Benedetti A; SPIN-CHAT Patient Advisory Team and Program Facilitators; Scleroderma Patient-centered Intervention Network Investigators. Effects of a multi-faceted education and support programme on anxiety symptoms among people with systemic sclerosis and anxiety during COVID-19 (SPIN-CHAT): a two-arm parallel, partially nested, randomised, controlled trial. Lancet Rheumatol. 2021 Jun;3(6):e427-e437. doi: 10.1016/S2665-9913(21)00060-6. Epub 2021 Apr 16.