Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04335279 |
| Other study ID # |
2021-2286 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2020 |
| Est. completion date |
July 24, 2020 |
Study information
| Verified date |
May 2022 |
| Source |
Lady Davis Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
