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BACKGROUND: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location OBJECTIVE: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. METHODS: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. RESULTS: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. CONCLUSIONS: This is the first known trial of an automated, self-guided, Web-based support program that uses a holistic approach in targeting both type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registration number: ACTRN12612000620820; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000620820 (Archived by WebCite at http://www.webcitation.org/6a3BeXC5m).
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BACKGROUND AND AIMS: Research into craving is hampered by lack of theoretical specification and a plethora of substance-specific measures. This study aimed to develop a generic measure of craving based on elaborated intrusion (EI) theory. Confirmatory factor analysis (CFA) examined whether a generic measure replicated the three-factor structure of the Alcohol Craving Experience (ACE) scale over different consummatory targets and time-frames. DESIGN: Twelve studies were pooled for CFA. Targets included alcohol, cigarettes, chocolate and food. Focal periods varied from the present moment to the previous week. Separate analyses were conducted for strength and frequency forms. SETTING: Nine studies included university students, with single studies drawn from an internet survey, a community sample of smokers and alcohol-dependent out-patients. PARTICIPANTS: A heterogeneous sample of 1230 participants. MEASUREMENTS: Adaptations of the ACE questionnaire. FINDINGS: Both craving strength [comparative fit indices (CFI = 0.974; root mean square error of approximation (RMSEA) = 0.039, 95% confidence interval (CI) = 0.035-0.044] and frequency (CFI = 0.971, RMSEA = 0.049, 95% CI = 0.044-0.055) gave an acceptable three-factor solution across desired targets that mapped onto the structure of the original ACE (intensity, imagery, intrusiveness), after removing an item, re-allocating another and taking intercorrelated error terms into account. Similar structures were obtained across time-frames and targets. Preliminary validity data on the resulting 10-item Craving Experience Questionnaire (CEQ) for cigarettes and alcohol were strong. CONCLUSIONS: The Craving Experience Questionnaire (CEQ) is a brief, conceptually grounded and psychometrically sound measure of desires. It demonstrates a consistent factor structure across a range of consummatory targets in both laboratory and clinical contexts.