Effectiveness of Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN) for adults with diabetes distress: A parallel group, pragmatic randomised 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 randomised controlled trial. Adults with diabetes distress (Problem Areas in Diabetes [PAID-20] score ≥25, or ≥2 on three or more items) were recruited via the National Diabetes Services Scheme (NDSS) and randomised (1:1) via central randomisation 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, 8 and 26 weeks. The primary outcome was the change in diabetes distress (PAID-20) from baseline to 26 weeks. Secondary outcomes included psychological distress (K-10), general emotional well-being (WHO-5) and coping-self-efficacy (CSE) at 8 and 26 weeks. Data were analysed using intention-to-treat principles.
RESULTS: Participants (n=429, 59% women, 40% men, 1% non-binary; median age 54 [IQR 42.0-63.5]; 37% type 1 diabetes, 63% type 2 diabetes) were enrolled and randomised 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 control (mean difference -7.2 [95% CI -11.6, -2.8]; p<0.001; Cohen's 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.