Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context
Summary: 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 fe...
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Elsevier
2025-03-01
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| Series: | The Lancet Regional Health. Europe |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666776224003740 |
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| author | Marietta Stadler Natalie Zaremba Amy Harrison Jennie Brown Divina Pillay Jacqueline Allan Rachael Tan Salma Ayis Emmanouela Konstantara Janet Treasure David Hopkins Khalida Ismail |
| author_facet | Marietta Stadler Natalie Zaremba Amy Harrison Jennie Brown Divina Pillay Jacqueline Allan Rachael Tan Salma Ayis Emmanouela Konstantara Janet Treasure David Hopkins Khalida Ismail |
| author_sort | Marietta Stadler |
| collection | DOAJ |
| description | Summary: 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.gov NCT05140564. 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). |
| format | Article |
| id | doaj-art-d1084f8251b24336a7e76e7b74b8cedf |
| institution | Kabale University |
| issn | 2666-7762 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
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| series | The Lancet Regional Health. Europe |
| spelling | doaj-art-d1084f8251b24336a7e76e7b74b8cedf2025-01-22T05:44:11ZengElsevierThe Lancet Regional Health. Europe2666-77622025-03-0150101205Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in contextMarietta Stadler0Natalie Zaremba1Amy Harrison2Jennie Brown3Divina Pillay4Jacqueline Allan5Rachael Tan6Salma Ayis7Emmanouela Konstantara8Janet Treasure9David Hopkins10Khalida Ismail11Department of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK; Corresponding author. School of Cardiovascular and Metabolic Medicine and Sciences, Clinical Diabetes Research Group, Weston Education Centre, 10 Cutcombe Road, London, SE5 9RJ, UK.Department of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK; Department of Medical Psychology, Radboud University Medical Center, Nijmegen, the NetherlandsDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK; Department of Psychology and Human Development, University College London, Institute of Psychiatry, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Diabetes, King's College Hospital, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Diabetes, King's College Hospital, London, UKSchool of Population Health& Environmental Sciences, King's College London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UKInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UKDepartment of Diabetes, Faculty of Life Sciences and Medicine, King's College London, London, UK; Diabetes Endocrinology and Obesity, King's Health Partners, London, UKDepartment of Psychological Medicine, Diabetes, Psychology and Psychiatry Research Group, King's College London, London, UK; Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UKSummary: 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.gov NCT05140564. 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).http://www.sciencedirect.com/science/article/pii/S2666776224003740Type 1 diabetesEating disorderCognitive behavioural therapyExperience based co-designRandomised controlled trial |
| spellingShingle | Marietta Stadler Natalie Zaremba Amy Harrison Jennie Brown Divina Pillay Jacqueline Allan Rachael Tan Salma Ayis Emmanouela Konstantara Janet Treasure David Hopkins Khalida Ismail Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context The Lancet Regional Health. Europe Type 1 diabetes Eating disorder Cognitive behavioural therapy Experience based co-design Randomised controlled trial |
| title | Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context |
| title_full | Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context |
| title_fullStr | Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context |
| title_full_unstemmed | Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context |
| title_short | Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trialResearch in context |
| title_sort | safety of a co designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders steady a feasibility randomised controlled trialresearch in context |
| topic | Type 1 diabetes Eating disorder Cognitive behavioural therapy Experience based co-design Randomised controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S2666776224003740 |
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