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. 2025 Jan 20:50:101205.
doi: 10.1016/j.lanepe.2024.101205. eCollection 2025 Mar.

Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial

Marietta Stadler  1   2 , Natalie Zaremba  1   2   3 , Amy Harrison  1   2   4 , Jennie Brown  1   5 , Divina Pillay  1 , Jacqueline Allan  1 , Rachael Tan  1   5 , Salma Ayis  6 , Emmanouela Konstantara  1 , Janet Treasure  7 , David Hopkins  1   8 , Khalida Ismail  2   7
Affiliations

Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial

Marietta Stadler et al. Lancet Reg Health Eur. .

Abstract

Background: Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) is a complex intervention for people with type 1 diabetes and mild-to-moderate disordered eating (T1DE) integrating cognitive behavioural therapy (CBT) with diabetes education. Aim was to test feasibility of STEADY in a randomised controlled trial.

Methods: Feasibility parallel-group, randomised (blocks of four) controlled open-label trial (RCT) of STEADY against usual care (Control) at King's College London, UK. Participants were referred by clinicians or self-referred via social media advertisements. Forty adults with T1DE (Hba1c < 15%, body mass index 15-35 kg/m2, age ≥ 18 years) were randomised. STEADY was delivered in 12 sessions by a CBT-trained Diabetes Specialist Nurse through video-conferencing and mobile app. Main outcome at 6 months post-randomisation was feasibility. Baseline mental health data (Structured Clinical Interview for DSM-5, SCID-5RV), and secondary biomedical outcomes (HbA1c; glucose time in range; TIR) and person-reported outcome measures (PROM: Diabetes Eating Problems Survey-Revised, DEPS-R; Eating Disorder Examination Questionnaire Short, EDE-QS; Type 1 Diabetes Distress Scale, T1DDS; Generalised Anxiety Disorder Assessment, GAD-7; Patient Health Questionnaire, PHQ-9; Impact of Diabetes Profile, DIDP) were collected. Analyses were conducted as intention-to-treat. ClinicalTrials.govNCT05140564.

Findings: Of the 98 screened, 40 participants with T1DE were randomised (recruitment rate: 40.81%; 95% CI: 31.60%, 50.72%): 38 women, 1 man, 1 trans man (37 White, 1 White/Asian, 1 Black; 39 ± 11 years old, diabetes duration 22 ± 15 years, HbA1c 9.1 ± 2.6%). The drop-out rate was 3/20 = 15% (4.39%, 36.55%) in STEADY and 2/20 = 10% (1.57%, 31.32%) in Control. STEADY reported lower GAD-7 (5.75 ± 2.89 vs 10.18 ± 5.31, p = 0.0060) and higher DIDP (3.13 ± 0.63 vs 2.46 ± 0.87, p = 0.020) at follow-up compared with Control, indicating lower anxiety and higher diabetes-specific quality-of-life. Compared to baseline, STEADY improved in DEPS-R, EDE-QS, GAD-7, PHQ-9 and T1DDS.

Interpretation: The STEADY-feasibility RCT demonstrated proof-of-concept for feasibility and mental health improvements in T1DE without deteriorating glycaemic control. A full scale RCT of STEADY will test effectiveness and implementation.

Funding: National Institute for Health Research (CS-2017-17-023).

Keywords: Cognitive behavioural therapy; Eating disorder; Experience based co-design; Randomised controlled trial; Type 1 diabetes.

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Conflict of interest statement

We declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flow chart of feasibility randomised controlled trial comparing STEADY with usual care in people with type 1 diabetes and eating disorders.
See this image and copyright information in PMC

References

    1. Goebel-Fabbri A.E., Fikkan J., Franko D.L., Pearson K., Anderson B.J., Weinger K. Insulin restriction and associated morbidity and mortality in women with type 1 diabetes. Diabetes Care. 2008;31(3):415–419. - PubMed
    1. Harrison A., Zaremba N., Brown J., et al. A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in people with type 1 diabetes mellitus. Diabet Med. 2021;38(7) - PubMed
    1. Staite E., Zaremba N., Macdonald P., et al. “Diabulima” through the lens of social media: a qualitative review and analysis of online blogs by people with Type 1 diabetes mellitus and eating disorders. Diabet Med. 2018;35(10):1329–1336. - PubMed
    1. Clery P.S.D., Ismail K., Treasure J., Kan C. 2017. A systematic review and meta-analysis on the efficacy of interventions for people with type 1 diabetes mellitus and disordered eating. in submission. - PubMed
    1. Ismail K., Turner D., Brown J., et al. An integrated diabetes and mental health intervention for people with type 1 diabetes and severe disordered eating: a prospective proof-of-concept cohort study. Lancet Diabetes Endocrinol. 2024;12(7):442–444. - PubMed

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