Khalida Ismail, BM BCh, PhD; Stephen M. Thomas, MB BS; Esther Maissi, MSc; Trudie Chalder, PhD; Ulrike Schmidt, MD, PhD; Jonathan Bartlett, MSc; Anita Patel, PhD; Christopher M. Dickens, MB BS, PhD; Francis Creed, MB, BChir, MD; Janet Treasure, MB BS, PhD
Acknowledgment: The authors thank the participants for their time and commitment in participating in the study; the diabetes physicians who gave permission and enduring support, together with their clinic and laboratory staff, and assisted in the recruitment and follow-up of participants (Professor Stephanie Amiel [King's College Hospital], Dr. Jake Powrie [Guy's Hospital], Mrs. Judy Adcock [Lewisham Hospital], Dr. Richard Savine [Mayday Hospital], Dr. Robert Davies [Manchester Royal Infirmary], Professor Phil Wiles [North Manchester General Hospital], and Dr. Ngai Kong [Stepping Hill Hospital]); the general practitioners who assisted with data collection; Dr. Kirsty Winkley; Ms. Judy Jackson (research psychologist) who did the recruitment, follow-up, and data collection in the Manchester sites; the Trial Steering Committee members (Professor Glyn Lewis, Dr. Dennis Barnes, and Dr. Bianca de Stavola) and the Data Ethics and Monitoring Committee (Professor Graham Dunn, Professor Robert Peveler, and Dr. Peter Watkins) for their intellectual guidance; Ms. Suzanne Roche (cognitive behavior therapy therapist, Maudsley Hospital) for contributing to the cognitive behavior therapy training and manual development; the nurse therapists who delivered the treatments; the Clinical Trials Unit, Institute of Psychiatry, King's College London, for the randomization and allocation concealment; and Dr. Keith Wiener (North Manchester General Hospital) for his guidance about hemoglobin A1c level measurements. Finally, the authors acknowledge the contribution of Mr. Phil Dickinson (dietician, Manchester Royal Infirmary), who died recently. Mr. Dickinson managed the diabetes database and contributed enthusiastically to this project and will be greatly missed by his colleagues.
Grant Support: By the United Kingdom Department of Health's Health Technology Assessment Programme (project no. 01/17/05).
Potential Financial Conflicts of Interest: None disclosed.
Reproducible Research Statement:Study protocol and data set: Available to approved individuals through written agreements with the author and subject to appropriate ethics committee review by contacting Dr. Ismail (e-mail, email@example.com). Statistical code: Available from Mr. Bartlett (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Khalida Ismail, BM BCh, PhD, Institute of Psychiatry, King's College London, Weston Education Centre, 10 Cutcombe Road, London SE5 9RJ, United Kingdom; e-mail: email@example.com.
Current Author Addresses: Drs. Ismail, Chalder, Schmidt, and Treasure and Ms. Maissi: Department of Psychological Medicine, Institute of Psychiatry, King's College London, 10 Cutcombe Road, London SE5 9RJ, United Kingdom.
Mr. Thomas: Diabetes Centre, Guy's and St Thomas' Hospital, Lambeth Palace Road, London SE1 7EH, United Kingdom.
Mr. Bartlett: Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene ##amp## Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.
Dr. Patel: Health Service and Population Research Department, Institute of Psychiatry, King's College London, De Crespigny Park, London SE5 9AZ, United Kingdom.
Drs. Dickens and Creed: Department of Psychiatry, University of Manchester, Rawnsley Building, Oxford Road, Manchester M13 9WL, United Kingdom.
Author Contributions: Conception and design: K. Ismail, S.M. Thomas, T. Chalder, U. Schmidt, A. Patel, C.M. Dickens, J. Treasure.
Analysis and interpretation of the data: K. Ismail, S.M. Thomas, T. Chalder, U. Schmidt, J. Bartlett, A. Patel, C.M. Dickens, J. Treasure.
Drafting of the article: K. Ismail, J. Bartlett, C.M. Dickens.
Critical revision of the article for important intellectual content: K. Ismail, S.M. Thomas, T. Chalder, U. Schmidt, J. Bartlett, A. Patel, C.M. Dickens, F. Creed, J. Treasure.
Final approval of the article: K. Ismail, S.M. Thomas, T. Chalder, U. Schmidt, A. Patel, C.M. Dickens, F. Creed, J. Treasure.
Provision of study materials or patients: S.M. Thomas, C.M. Dickens, F. Creed.
Statistical expertise: J. Bartlett.
Obtaining of funding: K. Ismail, F. Creed.
Administrative, technical, or logistic support: E. Maissi, F. Creed.
Collection and assembly of data: K. Ismail, E. Maissi, C.M. Dickens.
Although psychological issues can interfere with diabetes care, the effectiveness of psychological treatments in improving diabetes outcomes is uncertain.
To determine whether motivational enhancement therapy with or without cognitive behavior therapy improves glycemic control in type 1 diabetes compared with usual care.
Randomized, controlled trial.
8 diabetes centers in London and Manchester, United Kingdom.
344 adults with type 1 diabetes for longer than 2 years, with hemoglobin A1c levels of 8.2% to 15%, and without complications or severe comorbid disease.
Nurse-delivered motivational enhancement therapy (4 sessions over 2 months), motivational enhancement therapy plus cognitive behavior therapy (12 sessions over 6 months), or usual care.
12-month change in hemoglobin A1c levels (primary outcome), hypoglycemic events, depression, quality of life, fear of hypoglycemia, diabetes self-care activities, and body mass index (secondary outcomes).
In an analysis including all randomly assigned patients, the 12-month change in hemoglobin A1c levels compared with usual care was 0.46% (95% CI, 0.81% to 0.11%) in the motivational enhancement therapy plus cognitive behavior therapy group and 0.19% (CI, 0.53% to 0.16%) in the motivational enhancement therapy group alone. There was no evidence of treatment effects on secondary outcomes.
Of 1659 screened patients, only 507 were eligible and 344 participated. Data on the primary outcome were unavailable for 11.3% of the participants. Study design did not permit distinction of the additive effect of cognitive behavior therapy plus motivational enhancement therapy from the effect of greater intensity and duration of the combined intervention compared with the motivational enhancement therapy alone.
Nurse-delivered motivational enhancement therapy and cognitive behavior therapy is feasible for adults with poorly controlled type 1 diabetes. Combined therapy results in modest 12-month improvement in hemoglobin A1c levels compared with usual care, but motivational enhancement therapy alone does not.
Khalida Ismail, Stephen M. Thomas, Esther Maissi, Trudie Chalder, Ulrike Schmidt, Jonathan Bartlett, et al. Motivational Enhancement Therapy with and without Cognitive Behavior Therapy to Treat Type 1 Diabetes: A Randomized Trial. Ann Intern Med. 2008;149:708–719. doi: 10.7326/0003-4819-149-10-200811180-00005
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Published: Ann Intern Med. 2008;149(10):708-719.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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