TY - JOUR

T1 - Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN)

T2 - protocol for a hybrid type 1 effectiveness implementation trial

AU - Holloway, Edith E.

AU - Gray, Shikha

AU - Mihalopoulos, Cathrine

AU - Versace, Vincent L.

AU - Le Gautier, Roslyn

AU - Chatterton, Mary Lou

AU - Hagger, Virginia

AU - Halliday, Jennifer

AU - Henshaw, Kim

AU - Harrap, Benjamin

AU - Manallack, Sarah

AU - Black, Taryn

AU - Van Bruggen, Natasha

AU - Hines, Carolyn

AU - O’Neil, Adrienne

AU - Skinner, Timothy C.

AU - Speight, Jane

AU - Hendrieckx, Christel

N1 - Funding Information: This project receives funding from the Australian Government’s Targeted Translation Research Accelerator (TTRA) program, delivered by MTPConnect (grant number: TTRARP1089). MTPConnect was not involved in the study design, and will not be involved in the collection, analysis or interpretation of the study data. The decision to submit for publication was made independently by the authors. The project also receives contributions from partner organisations. Diabetes Australia provides cash and in-kind contributions that enable delivery of the LISTEN program (e.g. training, time, and infrastructure for health professionals). We also acknowledge cash and in-kind contributions from Diabetes Victoria, and in-kind contributions from the Australian Diabetes Educators Association. CH and JS are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. During protocol development, JAH was supported by an unrestricted educational grant provided to the Australian Centre for Behavioural Research in Diabetes (ACBRD) by Diabetes Australia. AO is supported by a National Health & Medical Research Council Emerging Leader 2 Fellowship (2009295). Publisher Copyright: © 2023, The Author(s).

PY - 2023/12

Y1 - 2023/12

N2 - 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 = 454) 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 1 February, 2022.

AB - 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 = 454) 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 1 February, 2022.

KW - Diabetes

KW - Diabetes distress

KW - Diabetes health professionals

KW - Emotional support

KW - Mental health

KW - Problem-solving

KW - Telehealth

U2 - 10.1186/s13063-023-07338-5

DO - 10.1186/s13063-023-07338-5

M3 - Journal article

C2 - 37221629

AN - SCOPUS:85160108791

VL - 24

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 350

ER -