Comparative Effectiveness of Two Versions of a Caring Contacts Intervention in Healthcare Providers, Staff, and Patients for Reducing Loneliness and Mental Distress: A Randomized Controlled Trial

Background: Caring Contacts can effectively reduce suicide ideation, attempts, and death. In published clinical trials, messages were sent by specialists who knew the recipient. At scale, Caring Contacts programs rarely introduce the recipient and sender. It is not known whether receiving Caring Contacts from someone unknown is as effective as messages from someone the recipient knows. Methods: Pragmatic single masked randomized controlled trial with 1:1 allocation to Caring Contacts with (CC+) versus without an introductory phone call (CC). Recruitment occurred January-July 2021, with outcomes assessed at 6 months. Participants were healthcare providers/staff and primary care patients at a not-for-profit health system in Idaho, United States reporting adverse mental health outcomes on a qualifying survey. CC+ calls focused on connection and were semi-structured. All participants were sent 11 standardized caring text messages over 6 months;when participants replied, they received personalized unscripted responses. The primary outcome was loneliness (NIH Toolkit). Findings: Among patients, 165 were randomized to CC+ (mean (SD) age: 46.7 (15.7), 79.4% female), and 166 were randomized to CC (mean (SD) age: 44.3 (17), 78.3% female). Among providers/staff, 167 were randomized to CC+ (mean (SD) age: 40.1 (11.4), 89.8% female), and 168 were randomized to CC (mean (SD) age: 41.6 (12.2), 83.3% female). There were no significant differences in loneliness at 6 months by treatment arm in either stratum. In patients, mean (SD) loneliness was 61.9 (10.7) in CC, and 60.8 (10.3) in CC+, adjusted mean difference of -1.0 (95% CI: -3.0, 1.0);p-value=0.31. In providers/staff, mean (SD) loneliness was 61.2 (11) in CC, and 61.3 (11.1) in CC+, adjusted mean difference of 0.2 (95% CI: -1.8, 2.2);p-value=0.83. Interpretation: Including an initial phone call added operational complexity and cost without significantly improving the effectiveness of a Caring Contacts program. Trial Registration: The Mental Health Among Patients, Providers, and Staff (MHAPPS) Trial is registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04700137), with the following identifier: NCT04700137.