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Motivational Enhancement Therapy with and without Cognitive Behavior Therapy to Treat Type 1 Diabetes: A Randomized Trial

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; and Janet Treasure, MB BS, PhD
[+] Article, Author, and Disclosure Information

ISRCTN registration number: ISRCTN77044517.

From King's College London, Guy's and St Thomas' Hospitals, and London School of Hygiene & Tropical Medicine, London, United Kingdom, and the University of Manchester, Manchester, United Kingdom.

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, khalida.ismail@iop.kcl.ac.uk). Statistical code: Available from Mr. Bartlett (e-mail, jonathan.bartlett@lshtm.ac.uk).

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: khalida.ismail@iop.kcl.ac.uk.

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 & 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.

Ann Intern Med. 2008;149(10):708-719. doi:10.7326/0003-4819-149-10-200811180-00005
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Figure 1 shows the study flow diagram. We identified a total of 1659 persons with a diagnosis of type 1 diabetes from clinic registers. We deemed 507 adults eligible, 344 of whom consented to participate. We recruited participants from September 2003 to August 2005 and followed them until November 2006. The proportion of participants allocated to motivational enhancement therapy (n = 117) and motivational enhancement therapy plus cognitive behavior therapy (n = 106) who completed their planned therapy (and the average time to do so) was 90% (3 months [SD, 1.8]) and 55% (6.8 months [SD, 1.8]), respectively (Figure 1).

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Figure 1.
Study flow diagram.

* Primary analysis was based on linear mixed models using data from all participants since all participants had at least baseline hemoglobin A1c levels measured.

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Figure 2.
Estimated quarterly mean hemoglobin A1c levels (95% CI), by intervention group.

Results based on 1000 imputed data sets generated by using a multivariate imputation model.

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Summary for Patients

Psychological Therapy to Improve Control of Type 1 Diabetes

The summary below is from the full report titled “Motivational Enhancement Therapy with and without Cognitive Behavior Therapy to Treat Type 1 Diabetes. A Randomized Trial.” It is in the 18 November 2008 issue of Annals of Internal Medicine (volume 149, pages 708-719). The authors are K. Ismail, S.M. Thomas, E. Maissi, T. Chalder, U. Schmidt, J. Bartlett, A. Patel, C.M. Dickens, F. Creed, and J. Treasure.


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