Evidence map›Paper›PMID 40944354›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2025

A quantitative process evaluation of a feasibility randomised controlled trial of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and disordered eating (steady trial): Auditing treatment integrity and delivery.

Amy Harrison, Natalie Zaremba, Jennie Brown, Divina Pillay, Jacqueline Allan, Rachael Tan, Janet Treasure, Khalida Ismail, Marietta Stadler

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2025. 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
–field-weighted citation impact
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.

  1. Trial
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

9 authors.

Amy HarrisonDepartment of Psychology and Human Development, University College London, Institute of Psychiatry, London, UK.
Natalie ZarembaDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.ORCID https://orcid.org/0000-0002-1720-1621
Jennie BrownDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Divina PillayDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Jacqueline AllanDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Rachael TanDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Janet TreasureInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Khalida IsmailDepartment of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK.
Marietta StadlerDepartment of Diabetes School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.ORCID https://orcid.org/0000-0001-6869-9960

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSafe management of people with Type 1 diabetes and Eating Disorders study (STEADY), a complex psychological intervention, defined by the Medical Research Council as involving multiple interacting components and individualised delivery, is a treatment designed for people with Type 1 diabetes and mild-to-moderate disordered eating (T1DE) which integrates cognitive behavioural therapy (CBT) with diabetes education. STEADY was previously tested in a feasibility randomised controlled trial (RCT), and the purpose of this work was to maximise trial learning to support future scaling up of STEADY in a multi-site RCT.

methodsThis study addressed three research questions: (1) Which STEADY toolkit tools were used in the intervention, and at which point? (2) To what extent was treatment delivered as intended, reflecting the minimum competency (≥3) on the Cognitive Therapy Rating Scale (Revised; CTS-R)? (3) How long did it take to deliver the STEADY intervention?

resultsA range of STEADY tools were used during the trial; the five most frequent tools were CBT formulation (72 uses), behavioural experiments (47 uses), thought records (43 uses), goal setting (40 uses) and understanding emotions and 'riding the wave' (40 uses). The CTS-R mean score was 3.81 ± 0.74, indicating competent adherence to CBT. Mean time to completion was 153.3 days (SD = 73).

conclusionsWhen scaling up for a multi-site RCT, some participants may need greater flexibility regarding timing to access all STEADY sessions. STEADY can be personalised through its toolkit-based approach, and therapists should be mindful and trained in the range of tools available.

Indexed as

Cognitive Behavioral TherapyDiabetes Mellitus, Type 1Feeding and Eating DisordersAdultFeasibility StudiesFemaleHumansMaleMulticenter Studies as Topiccognitive behavioural therapydisordered eatingeating disordersprocess evaluationrandomised controlled trialType 1 diabetes

Identifiers

PMID40944354
PMCPMC12535373

What Socratic 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 Socratic graph.