Low Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): Protocol for a hybrid type 1 effectiveness implementation trial

Author:

Holloway Edith E1ORCID,Gray Shikha1,Mihalopoulos Catherine2,Versace Vincent L1,Gautier Roslyn Le1,Chatterton Mary Lou2,Hagger Virginia1,Halliday Jennifer1,Henshaw Kim3,Harrap Benjamin1,Manallack Sarah1,Black Taryn4,Bruggen Natasha Van4,Hines Carolyn5,O’Neil Adrienne1,Skinner Timothy C6,Speight Jane1,Hendrieckx Christel1

Affiliation:

1. Deakin University

2. Monash University

3. Community representative

4. Diabetes Australia

5. Diabetes Victoria

6. La Trobe University

Abstract

Abstract Background Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). Methods A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 394) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN - a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. Discussion It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. Trial registration : This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on the 1 February, 2022.

Publisher

Research Square Platform LLC

Reference50 articles.

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5. Australian Government Department of Health. Australian National Diabetes Strategy 2021-2030. 2021 12 November 2021. [Available from: https://www.health.gov.au/sites/default/files/documents/2021/11/australian-national-diabetes-strategy-2021-2030_0.pdf].

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