The effect of a multifaceted mental health intervention on anxiety symptoms were assessed in patients with systemic sclerosis (SSc) during the COVID-19 pandemic, in a study published in Lancet Rheumatology.
The Scleroderma Patient-Centered Intervention Network COVID-19 Home-Isolation Activities Together trial (SPIN-CHAT; ClinicalTrials.gov Identifier: NCT04335279) included patients with SSc and anxiety from an existing international SSc cohort and through social media announcements. Patients who had previously tested positive for COVID-19 and who were receiving mental health treatment were excluded from the study. Study enrollees were randomly assigned 1:1 to either the SPIN-CHAT program or the waitlist control condition.
The SPIN-CHAT program was a 2-arm, parallel, partially nested, randomized, controlled trial, which was a 4-week, group videoconferencing-based intervention. Groups of 6 to 10 participants met 3 times per week in 90-minute sessions, which provided education on mental health coping strategies. Socialization with other members was facilitated to reduce isolation. The primary outcome was reduction from baseline to post-intervention in anxiety symptoms, according to the PROMIS Anxiety 4a version 1.0 scale. Anxiety symptoms were measured 6 weeks post-intervention. Depression symptoms were captured at the same timepoints using the 8-item Patient Health Questionnaire (PHQ-8). Patients in the control group were offered access to the SPIN-CHAT program after trial conclusion. Standardized mean difference (SMD) in anxiety symptom reduction between the intervention and control groups was calculated for each timepoint.
A total of 172 patients were assigned to the intervention (n=86) or waitlist (n=86) group. Mean age was 55.0±11.4 years; 162 (94%) were women; and 136 (79%) were White. Participants were from the United States (n=61; 35%), Canada (n=50; 29%), France (n=28; 16%), the United Kingdom (n=12; 7%), Australia (n=11; 6%), and 7 other countries (n=10; 6%). Mean time since diagnosis was 11.3±7.7 years, and 42% of participants had diffuse SSc. Mean number of intervention sessions attended was 8.8±4.6; 44% of participants attended all 12 sessions.
Post-intervention, anxiety symptoms or other mental health outcomes were not significantly reduced (-1.57 points; 95% CI, -3.59 to 0.45). Anxiety scores were not significantly different between the intervention and control groups (SMD, -0.22; 95% CI, -0.46 to 0.03). However, 6 weeks post-intervention, anxiety scores were significantly lower in the intervention vs control group (SMD, -0.31; 95% CI, -0.58 to -0.03). Depression symptoms were also significantly reduced at 6 weeks post-intervention (SMD, -0.31; 95% CI, -0.55 to -0.07), but not immediately post-intervention (SMD, -0.11; 95% CI, -0.31 to 0.09).
Among patients who completed the 8-item Client Satisfaction Questionnaire (n=73), program satisfaction was high. Mean satisfaction score was 28.7±3.8 of a possible 32. No adverse events were reported.
Results from this trial suggest that a videoconferencing-based anxiety intervention may be an effective way of addressing anxiety among patients with SSc during the COVID-19 pandemic. While anxiety and depression symptoms were not significantly reduced post-intervention, substantial improvements were observed 6 weeks later, indicating a lag time in the efficacy of SPIN-CHAT Program materials.
Study limitations include attrition; 22% of participants only attended 1 or 2 intervention sessions, which may have reduced the observed effect of program materials on anxiety. In addition, baseline anxiety and depression symptoms were relatively low; results may not be generalizable to patients with more severe mental health challenges.
“Multifaceted interventions such as SPIN-CHAT might be useful tools to address mental health needs in vulnerable groups during COVID-19,” the investigators wrote. “There is, however, uncertainty about the effectiveness, which should be investigated in additional studies.”
Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of the author’s disclosures.
Thombs BD, Kwakkenbos L, Levis B, et al; SPIN-CHAT Patient Advisory Team and Program Facilitators on behalf of the 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. Published online April 16, 2021. doi:10.1016/S2665-9913(21)00060-6