title: A mobile phone and web-based intervention for improving mental well-being in young people with type 1 diabetes: design of a randomized controlled trial.
abstract: BACKGROUND
  Young people with type 1 diabetes experience elevated levels of emotional distress that impact negatively on their diabetes self-care, quality of life, and disease-related morbidity and mortality. While the need is great and clinically significant, a range of structural (eg, service availability), psychological (eg, perceived stigma), and practical (eg, time and lifestyle) barriers mean that a majority of young people do not access the support they need to manage the emotional and behavioral challenges of type 1 diabetes.
  
  
  OBJECTIVE
  The aim of this study is to examine the effectiveness of a fully-automated cognitive behavior therapy-based mobile phone and Web-based psychotherapeutic intervention (myCompass) for reducing mental health symptoms and diabetes-related distress, and improving positive well-being in this vulnerable patient group.
  
  
  METHODS
  A two-arm randomized controlled trial will be conducted. Young people with type 1 diabetes and at least mild psychological distress will be recruited via outpatient diabetes centers at three tertiary hospitals in Sydney, Australia, and referred for screening to a study-specific website. Data will be collected entirely online. Participants randomized to the intervention group will use the myCompass intervention for 7 weeks, while at the same time a control group will use an active placebo program matched to the intervention on duration, mode of delivery, and interactivity.
  
  
  RESULTS
  The primary outcome will be mental well-being (ie, depression, anxiety, diabetes-related distress, and positive well-being), for which data will be collected at baseline, post-intervention, and after 3 months follow-up. Secondary outcomes will be functional (work and social functioning and diabetes self-care), biochemical measures (HbA1c), and mental health self-efficacy. We aim to recruit 280 people into the study that will be conducted entirely online. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures.
  
  
  CONCLUSIONS
  We hypothesize that scores on the outcome measures will improve significantly for young people who use the mobile phone and Web-based intervention compared to the control group. myCompass is a public health intervention that is broadly available and free to use. If effective, the program has the capacity to provide convenient and accessible evidenced-based care to the large group of young people with type 1 diabetes who do not currently access the psychosocial support they need.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12614000974606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366607 (Archived by WebCite at http://www.webcitation.org/6YGdeT0Dk).
authors.affiliation: Black Dog Institute and UNSW, Sydney, Australia. janine.clarke@unsw.edu.au.
authors.forename: Janine
authors.identifier: http://orcid.org/0000-0002-2652-5273
authors.initials: J
authors.lastname: Clarke
authors.forename: Veronica
authors.identifier: http://orcid.org/0000-0002-8630-3859
authors.initials: V
authors.lastname: Vatiliotis
authors.forename: Charles F
authors.identifier: http://orcid.org/0000-0001-9343-258X
authors.initials: CF
authors.lastname: Verge
authors.forename: Jane
authors.identifier: http://orcid.org/0000-0002-3640-1370
authors.initials: J
authors.lastname: Holmes-Walker
authors.forename: Lesley V
authors.identifier: http://orcid.org/0000-0001-7775-0246
authors.initials: LV
authors.lastname: Campbell
authors.forename: Kay
authors.identifier: http://orcid.org/0000-0002-8542-6478
authors.initials: K
authors.lastname: Wilhelm
authors.forename: Judy
authors.identifier: http://orcid.org/0000-0002-3872-9871
authors.initials: J
authors.lastname: Proudfoot
keywords: Internet intervention; depression; diabetes-related distress; randomized controlled trial; type 1 diabetes