Type 1 diabetes is one of the most common chronic diseases of childhood [1]. It is a leading cause of global disease burden [2], and prevalence rates are increasing [3,4]. Insulin deficiency, the hallmark feature of type 1 diabetes, requires life-long management of a complex and demanding self-care regimen that aims to optimize glycemic control and prevent the onset of potentially fatal short- (eg, hypoglycemia and diabetic ketoacidosis) and long-term (eg, micro-vascular and macro-vascular disorders, peripheral nerve disease, and blood vessel disease) health complications [1]. How well young people cope with the challenges of type 1 diabetes, while simultaneously negotiating the normal developmental tasks of childhood, adolescence, and the transition to adulthood, has important implications for their overall physical health, psychological well-being, quality of life, and life expectancy [5].

People with type 1 diabetes feel challenged emotionally by the daily hassles, frustrations, and worries that stem from having a serious and chronic medical condition [6], and are at greater risk of common mental health problems, especially depression, than their peers without diabetes [7,8]. This is clinically important because of the links between psychological morbidity and such adverse health outcomes as greater diabetes symptom burden and functional impairment, decreased diabetes self-care, poorer glycemic control, higher rates of diabetes complications, and failure to transition from pediatric to adult diabetes services [9-11]. Even mild (subclinical) emotional distress has been demonstrated in longitudinal studies to predict “worse-than-expected” clinical and psychological outcomes in adulthood for young people with diabetes, including recurrent hospital admissions for diabetic ketoacidosis [12].

A meta-analysis of interventions for clinical and subclinical depression clearly demonstrated the benefits for mental health and diabetes outcomes [13], yet most young people with type 1 diabetes do not receive the psychological support they need to manage the emotional and behavioral challenges of their diabetes [14,15]. Barriers to obtaining psychological support include insufficient providers of mental health services, poor mental health literacy (ie, lack of knowledge of signs and symptoms), the prioritization of physical symptoms in traditional models of diabetes care, and a range of practical constraints (eg, time, lifestyle, and financial) [6]. Furthermore, there is evidence that many young people with type 1 diabetes find it difficult to discuss mental health issues with their health care providers [15], thus delaying and/or avoiding seeking psychosocial support. There is, therefore, considerable opportunity to improve mental and physical health outcomes for young people with type 1 diabetes by increasing access to psychosocial support that reduces geographic, temporal, and financial barriers to access, and offers advantages of user confidentiality and anonymity.

As an important part of the everyday lives of young people [16,17], the Internet has demonstrated its potential to overcome many of the barriers to accessing mental health services [18], evolving as a popular, efficient, and clinically effective means of delivering empirically supported psychological interventions to the public, including people with diabetes [19-22]. Young people report feeling empowered and comfortable exploring sensitive and stigmatized issues online [23], and online resources, including websites, forums, and social networking sites, are increasing in popularity as sources of mental health support [16,17,24]. Surprisingly, however, there is little research examining the efficacy of Internet delivered psychotherapeutic interventions for reducing distress and improving psychological well-being in young people with type 1 diabetes.

Therefore, the current study seeks to evaluate the feasibility, acceptability, and clinical effectiveness for improving mental well-being in young people with type 1 diabetes of a fully-automated mobile phone and Web-based intervention, myCompass. Grounded in cognitive behavior therapy (CBT), the myCompass program has been demonstrated in a randomized controlled trial (RCT) to reduce symptoms and functional impairment in members of the community with mild to moderate levels of depression, anxiety, and stress [25]. Additional pilot data from an uncontrolled study suggest that not only general distress but also diabetes-specific emotional problems are improved (unpublished data by Clarke, Proudfoot, and Ma, 2014).

Our primary hypothesis is that young people with type 1 diabetes who use the myCompass program for 7 weeks will report fewer mental health symptoms (depression, anxiety, and diabetes-related distress), and improved positive well-being compared to an active placebo control group. Our secondary hypothesis is that use of myCompass will lead to greater functional gains (diabetes self-care, and work and social functioning), and improvements in glycemic control than the comparison intervention.

A 2 (conditions) x 3 (time) RCT design is planned. Participants will be randomized to either the myCompass intervention or an active placebo intervention, and each group will have full program access for 7 weeks. Outcomes will be assessed at baseline, post-intervention (8 weeks), and three months follow-up (Figure 1).

Participants will have access to the full intervention on their mobile phones and computer devices for 7 weeks. Although participants will be encouraged to use the programs ad libitum during the intervention period, it will be recommended that they complete at least two program modules in their own time. Assessment will be conducted completely online. At each assessment time-point, participants will receive an email asking them to log into the study website to complete the outcome measures. The email sent at 3-months follow-up will also prompt participants to visit their diabetes specialist for assessment of glycosylated haemoglobin (HbA1c).

Randomization to either myCompass or the active placebo intervention will be carried out after baseline measurement, according to a sequence generated by a computerized random-number generator [32] using permutated blocks of 2, 4, and 8. The randomization process will be facilitated by a researcher not involved with the study. Participants will receive login details for their respective interventions by email.

The assessments that will be completed at baseline, post-treatment, and 3-months follow-up are summarized in Table 1. Demographic data will include gender, age, marital status, highest education level, and whether the young person is currently working and/or studying. Disease-related information will include age at diagnosis, treatment modality, and diabetes complications status. Participants will also nominate their general practitioner (GP) and diabetes specialist in order to facilitate risk management and the collection of HbA1c results by research personnel.

If any participant indicates a significant worsening of their psychological distress (defined as a score of >19 on the PHQ-9 either midway through the intervention period, at post-intervention, or follow-up) they will be sent an email from the research team advising them to contact their GP to arrange face-to-face support. A second email, sent 3 days later, will seek confirmation that contact with the GP has been made. If no contact has been made, or if no reply email is received, participants will be informed by email that the principal investigator of the study will contact their nominated GP to recommend they receive appropriate face-to-face support.

The RCT of myCompass yielded an average between-group effect size on symptom outcomes of d=0.5 [25]. Van Bastellar et al [22] also reported controlled effect sizes of an online intervention for people with diabetes in the vicinity of d=0.5 for diabetes-related distress and depressive symptoms. Assuming an attrition rate of 50% [49,50], a total sample of 240 participants at follow-up (120 per arm) is the minimum required to detect between-group differences on self-report outcomes of .5 standard deviations with 80% power.

Nevertheless, we will aim for a final sample size 280 participants (140 per arm), as we have pilot data showing that this will enable us to detect a clinically meaningful decrease in HbA1c of 0.5% with power at 80%. This is based on analysis of clinic patients at Sydney Children’s Hospital, revealing a standard deviation of 1.04 for the change in HbA1c over 3 months. Recruitment is currently underway for this study.

Analyses will be completed with SPSS 22 software. Chi-squares (categorical variables) and t tests (continuous variables) will be used to compare demographic and disease-related variables and baseline scores on the outcome measures for the intervention and attention control groups. Similar analyses will be performed comparing participants who do (non-dropouts) and do not (dropouts) return completed questionnaires at each of the post-intervention and follow-up assessments to explore possible biases in study attrition.

Outcomes at each time point will be analyzed on an intention-to-treat basis using linear mixed modeling (LMM) [51], with time points as a within-group factor and intervention as a between-group factor. In LMM, incomplete cases are included in the analysis, and all available data is used to obtain parameter estimates. The interaction of time and study condition will be of primary interest in each analysis, with a significant interaction indicating a group difference in the pattern of change over time in the outcome of interest. Significant interactions will be explored using sets of Bonferroni adjusted comparisons of the two groups at post-intervention and 3-month follow-up. All effects will be tested at P<.05, with adjustment according to the number of contrasts in each set. Within- and between-group effect sizes will be calculated using Cohen’s d (based on the pooled standard deviation).

Reviews have highlighted the need for flexibility and innovation in reducing the substantial unmet need for psychosocial care in young people with type 1 diabetes [6,15]. To our knowledge, this study will be the first to examine the effectiveness of a fully-automated, self-help intervention that is generic in its content and delivered via the Internet to computers, tablets, and mobile phones for reducing mental health symptoms and improving mental well-being in this vulnerable patient group. myCompass is a public health intervention of demonstrated efficacy [25]. We hypothesize that general and diabetes-specific distress and psychological well-being will improve significantly in young people randomized to myCompass for 7 weeks compared to those randomized to an active placebo intervention.

Intervening to reduce psychological distress in young people with type 1 diabetes is important as emotional difficulties are associated with poorer self-care and high disease-related morbidity and mortality [9-11]. Furthermore, in the absence of treatment, psychological distress during the transition from childhood to adulthood may persist throughout life, thereby substantially increasing the longer-term personal and societal burden of the disease [12]. The preferred communication media of young people [52], delivering mental health care via the Internet and mobile phones may be particularly attractive to many young patients who are reluctant to access traditional face-to-face supports. Moreover, if found to be effective, myCompass is broadly available free of charge and could potentially reach large numbers of young people with type 1 diabetes for whom service availability and cost are major barriers to access.

Previous studies of psychological interventions for people with diabetes have tended to focus on depressive symptoms and diabetes-specific outcomes (eg, diabetes-related distress and diabetes self-care). By taking a broader approach and examining general and disease-specific distress (depression, anxiety, and diabetes-related distress), functional outcomes (work and social adjustment, and diabetes self-care), and positive mental health, this study provides a comprehensive evaluation of the effects of the web and mobile phone program on variables known to correlate with quality of life and health outcomes in people with diabetes [53,54]. An additional strength of this study is the examination of potential moderators (eg, demographic and disease-related variables, and mental health self-efficacy) of the effect of the intervention on outcome measures. These analyses may assist in identifying the young people with type 1 diabetes who are most likely to benefit from psychosocial support delivered via the Internet.

Recruitment of participants through tertiary hospital diabetes outpatient clinics is an obvious limitation of this study, and means that our findings may not generalize to young people with type 1 diabetes managed outside the hospital system. Nevertheless, because it can be difficult to recruit young people into RCTs [55], and given our target sample size of 280, we feel that the proposed recruitment strategy will ensure timely and cost-effective data collection. In addition, recruitment via hospitals will enable us to examine the potential advantages and disadvantages of including the myCompass intervention as part of routine specialist care for young people with type 1 diabetes.

Another possible limitation relates to the brevity of the study and the time intervals for measurement. Whereas the proposed assessments (immediately post-intervention and at 3-months follow-up) are sufficient to demonstrate change in the primary and secondary outcome measures, a longer-term follow-up is necessary to determine the consistency of the study findings and the pattern of the effects of the intervention over time. For this reason, consent will be sought from participants at 10 months for a supplementary 12 months follow-up assessment. Separate ethics approvals will be obtained for this part of the study and the data will be analyzed and reported independently of this project.

The increasing prevalence of type 1 diabetes, the heightened risk of emotional difficulties in young people with the disease, and the substantial unmet need for psychosocial support, make a compelling case for trials of novel mental health interventions in this patient group. Using popular everyday tools such as mobile phones, tablets, and the Internet, this project will be the first to examine the effectiveness of a fully-automated, self-help intervention without diabetes-specific content for reducing distress and improving well-being for young people with type 1 diabetes. The myCompass intervention is widely accessible, with over 14,000 registrants since 2012. The program has the capacity to provide convenient, accessible (24 hours a day, 7 days a week), and clinically effective psychosocial care at no cost to young people who might otherwise have limited access to (or choose not to access) alternative sources of psychosocial support.