Evidence map›Paper›PMID 37221629›Full record

ArticleTrials2023

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

Edith E Holloway, Shikha Gray, Cathrine Mihalopoulos, Vincent L Versace, Roslyn Le Gautier, Mary Lou Chatterton, Virginia Hagger, Jennifer Halliday, Kim Henshaw, Benjamin Harrap and 8 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 11 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 2 countries.

Edith E HollowaySchool of Psychology, Deakin University, Geelong, VIC, Australia. eholloway@acbrd.org.au.ORCID http://orcid.org/0000-0002-1343-9982
Shikha GraySchool of Psychology, Deakin University, Geelong, VIC, Australia.
Cathrine MihalopoulosSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Vincent L VersaceSchool of Medicine, Deakin Rural Health, Deakin University, Warrnambool, VIC, Australia.
Roslyn Le GautierSchool of Psychology, Deakin University, Geelong, VIC, Australia.
Mary Lou ChattertonSchool of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Virginia HaggerInstitute for Health Transformation, Deakin University, Geelong, Australia.
Jennifer HallidaySchool of Psychology, Deakin University, Geelong, VIC, Australia.
Kim Henshaw, Victoria, Australia.
Benjamin HarrapSchool of Medicine, Deakin Rural Health, Deakin University, Warrnambool, VIC, Australia.
Sarah ManallackSchool of Psychology, Deakin University, Geelong, VIC, Australia.
Taryn BlackDiabetes Australia, Milton, QLD, Australia.
Natasha Van BruggenSchool of Nursing & Midwifery, Deakin University, Burwood, VIC, Australia.
Carolyn HinesDiabetes Victoria, Victoria, Australia.
Adrienne O'NeilIMPACT Institute, Deakin University, Geelong, VIC, Australia.
Timothy C SkinnerThe Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.
Jane SpeightSchool of Psychology, Deakin University, Geelong, VIC, Australia.
Christel HendrieckxSchool of Psychology, Deakin University, Geelong, VIC, Australia.
Deakin University · AUDiabetes Australia · AUMonash University · AUUniversity of Copenhagen · DK

Funding

Australian Government Department of Health TTRARP1089
6 · The paper itself

Abstract

backgroundMental 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).

methodsA 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 registrationThis trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

Indexed as

Diabetes MellitusTelemedicineAdaptation, PsychologicalAdultAustraliaHumansMental HealthPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicDiabetesDiabetes distressDiabetes health professionalsEmotional supportMental healthProblem-solvingTelehealth

Identifiers

PMID37221629
PMCPMC10204211
OpenAlexW4377940913

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.