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      The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol

      , BA, PGDipPsych, MPsych(Clinical), PhD (Psych) 1 , 2 , , , BA (Hons), Dipl-Psych, MApsych, PhD (Psych) 2 , , BEd, MSc, PhD 3 , 4 , , BNursing, MEd, PhD 5 , , BA, PGDip, PhD 6 , , B Med, MD, Diploma, MSc Health Policy, MSc Public Health, PG Cert Med Quality Management 7 , , BSc Psychology, Hons (Psychology) 2 , 7
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications Inc.
      diabetes mellitus, Type 2, depression, anxiety, self care, Internet, Web, online systems, intervention studies, randomized controlled trial, therapy, computer-assisted

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          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


          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.


          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.


          This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia.


          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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          Most cited references55

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          The prevalence of comorbid depression in adults with diabetes: a meta-analysis.

          To estimate the odds and prevalence of clinically relevant depression in adults with type 1 or type 2 diabetes. Depression is associated with hyperglycemia and an increased risk for diabetic complications; relief of depression is associated with improved glycemic control. A more accurate estimate of depression prevalence than what is currently available is needed to gauge the potential impact of depression management in diabetes. MEDLINE and PsycINFO databases and published references were used to identify studies that reported the prevalence of depression in diabetes. Prevalence was calculated as an aggregate mean weighted by the combined number of subjects in the included studies. We used chi(2) statistics and odds ratios (ORs) to assess the rate and likelihood of depression as a function of type of diabetes, sex, subject source, depression assessment method, and study design. A total of 42 eligible studies were identified; 20 (48%) included a nondiabetic comparison group. In the controlled studies, the odds of depression in the diabetic group were twice that of the nondiabetic comparison group (OR = 2.0, 95% CI 1.8-2.2) and did not differ by sex, type of diabetes, subject source, or assessment method. The prevalence of comorbid depression was significantly higher in diabetic women (28%) than in diabetic men (18%), in uncontrolled (30%) than in controlled studies (21%), in clinical (32%) than in community (20%) samples, and when assessed by self-report questionnaires (31%) than by standardized diagnostic interviews (11%). The presence of diabetes doubles the odds of comorbid depression. Prevalence estimates are affected by several clinical and methodological variables that do not affect the stability of the ORs.
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            Association of depression and diabetes complications: a meta-analysis.

            The objective of this study was to examine the strength and consistency of the relationship between depression and diabetes complications in studies of type 1 and type 2 adult patients with diabetes. MEDLINE and PsycINFO databases were searched for articles examining depression and diabetes complications in type 1 and type 2 diabetes samples published between 1975 and 1999. Meta-analytic procedures were used. Studies were reviewed for diabetes type, sample size, statistical tests, and measures of diabetes complications and depression. Significance values, weighted effect sizes r, 95% confidence intervals (CI), and tests of homogeneity of variance were calculated for the overall sample (k = 27) and for subsets of interest. A total of 27 studies (total combined N = 5374) met the inclusion criteria. A significant association was found between depression and complications of diabetes (p < .00001, z = 5.94). A moderate and significant weighted effect size (r = 0.25; 95% CI: 0.22-0.28) was calculated for all studies reporting sufficient data (k = 22). Depression was significantly associated with a variety of diabetes complications (diabetic retinopathy, nephropathy, neuropathy, macrovascular complications, and sexual dysfunction). Effect sizes were in the small to moderate range (r = 0.17 to 0.32). These findings demonstrate a significant and consistent association of diabetes complications and depressive symptoms. Prospective, longitudinal studies are needed to identify the pathways that mediate this association.
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              Imaginary Relish and Exquisite Torture: The Elaborated Intrusion Theory of Desire.

              The authors argue that human desire involves conscious cognition that has strong affective connotation and is potentially involved in the determination of appetitive behavior rather than being epiphenomenal to it. Intrusive thoughts about appetitive targets are triggered automatically by external or physiological cues and by cognitive associates. When intrusions elicit significant pleasure or relief, cognitive elaboration usually ensues. Elaboration competes with concurrent cognitive tasks through retrieval of target-related information and its retention in working memory. Sensory images are especially important products of intrusion and elaboration because they simulate the sensory and emotional qualities of target acquisition. Desire images are momentarily rewarding but amplify awareness of somatic and emotional deficits. Effects of desires on behavior are moderated by competing incentives, target availability, and skills. The theory provides a coherent account of existing data and suggests new directions for research and treatment.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                Jul-Sep 2015
                04 August 2015
                : 4
                : 3
                : e97
                [1] 1The Wesley Health and Medical Research Centre Rural and remote health centre BrisbaneAustralia
                [2] 2Queensland University of Technology Institute of Health and Biomedical Innovation BrisbaneAustralia
                [3] 3Mater Mothers Hospital, Mater Medical Research Institute Level 3 Aubigny Place, Raymond Terrace South Brisbane, 4101 BrisbaneAustralia
                [4] 4Griffith Health Institute Griffith University BrisbaneAustralia
                [5] 5University of Queensland Centre for Online Health Ground Floor, Main Building, Princess Alexandra Hospital Woollongabba, 4102 BrisbaneAustralia
                [6] 6Griffith University School of Medicine & Griffith Health Institute Griffith University Drive Meadowbrook, 4131 BrisbaneAustralia
                [7] 7The Wesley Health and Medical Research Centre Level 8 East Wing, The Wesley Hospital Auchenflower, 4066 BrisbaneAustralia
                Author notes
                Corresponding Author: Mandy Cassimatis mandy.cassimatis@ 123456usq.edu.au
                Author information
                ©Mandy Cassimatis, David John Kavanagh, Andrew Paul Hills, Anthony Carl Smith, Paul A Scuffham, Christian Gericke, Sophie Parham. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.08.2015.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 2 July 2013
                : 25 August 2013
                : 2 September 2014
                : 6 September 2014

                diabetes mellitus, type 2,depression,anxiety,self care,internet,web,online systems,intervention studies,randomized controlled trial,therapy, computer-assisted


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