Effectiveness of Low Intensity Mental Health Support via a Telehealth Enabled Network (LISTEN) for Adults With Diabetes Distress: A Parallel Group, Pragmatic Randomized Controlled Trial

OBJECTIVE: To assess the effectiveness of Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals, for reducing diabetes distress among adults with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: A two-arm, parallel group, pragmatic randomized controlled trial. Adults with diabetes distress (20-item Problem Areas in Diabetes [PAID] score ≥25, or ≥2 on three or more items) were recruited via the National Diabetes Services Scheme (NDSS) and randomized (1:1) via central randomization by computer to LISTEN (maximum four sessions of problem-solving therapy) or usual care (web-based resources about diabetes and emotional health). Participants completed self-report online surveys at baseline and at 8 and 26 weeks. The primary outcome was the change in diabetes distress (PAID) from baseline to 26 weeks. Secondary outcomes included psychological distress (10-item Kessler Psychological Distress Scale), general emotional well-being (World Health Organization 5-item Well-being Index) and coping self-efficacy at 8 and 26 weeks. Data were analyzed using intention-to-treat principles. RESULTS: Participants (n = 429, 59% women, 40% men, 1% nonbinary; median age 54 [interquartile range 42.0-63.5]; 37% type 1 diabetes, 63% type 2 diabetes) were enrolled and randomized to the intervention (n = 216) or control group (n = 213). Over 26 weeks, there was a greater reduction in diabetes distress among the LISTEN group versus the control group (mean difference -7.2 [95% CI -11.6, -2.8]; P < 0.001; Cohen f2 = 0.03) and greater improvements in general emotional well-being and coping self-efficacy. No adverse events were reported. CONCLUSIONS: LISTEN is an effective, low-intensity program, addressing the unmet needs of adults with type 1 and type 2 diabetes experiencing mild-to-moderate diabetes distress.