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Development and Validation of a New Measure to Evaluate Psychological Resistance to Insulin Treatment

¹ Department for Psychosomatic Medicine and Psychotherapy, LWL-Clinic Dortmund/Ruhr-University of Bochum, Dortmund, Germany
² Pfizer Pharma, Karslruhe, Germany
³ Department of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilian University, Munich, Germany
⁴ Institute for Clinical Research and Development, Institut für Klinische Forschung und Entwicklung, Mainz, Germany

Address correspondence and reprint requests to Dr. Frank Petrak, LWL-Klinik Dortmund/Ruhr-Universität Bochum, c/o Schulberg 7-9, 65183 Wiesbaden, Germany. E-mail: mail{at}dr-frank-petrak.de

OBJECTIVE—To develop a psychometric questionnaire to measure psychological barriers to insulin treatment in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS—Scale development was based on principal component analyses in two cross-sectional studies of insulin-naïve patients with type 2 diabetes. The structure of the questionnaire was developed in the first sample of 448 patients and subsequently cross-validated in an independent sample of 449 patients.

RESULTS—Analyses in the first sample yielded five components that accounted for 74.5% of the variance based on 14 items and led to the following subscales: fear of injection and self-testing, expectations regarding positive insulin-related outcomes, expected hardship from insulin treatment, stigmatization by insulin injections, and fear of hypoglycemia. In addition, an overall sum score of all values was calculated. The structure of the questionnaire was cross-validated in the second sample, with almost identical component loadings and an explained variance of 69.4%. An additional confirmatory factor analysis also indicated an acceptable to good model fit with root mean square error of approximation equal to 0.04 and comparative fit index equal to 0.97. Coefficients of reliability (Cronbach's 0.62–0.85 and 0.78 for overall sum score) were acceptable, considering the very small number of items for each scale.

CONCLUSIONS—The Barriers to Insulin Treatment Questionnaire appears to be a reliable and valid measure of psychological insulin resistance in patients with type 2 diabetes. This short instrument is easy to administer and may be used by both clinicians and researchers to assess the psychological barriers to insulin treatment.

Abbreviations: BIT, Barriers to Insulin Treatment • CFA, confirmatory factor analysis • CFI, comparative fit index • OAD, oral antidiabetes treatment • RMSEA, root mean square error of approximation

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