Rationale: Type 1 diabetes is a disease that asks constant attention, self-care activities
and responsibility from the diagnosed person for the duration of their entire life. Because
of this constant burden, many people with type 1 diabetes experience mental health problems
such as fatigue, excessive worrying about their blood glucose (especially about dangerously
low blood glucose), or eating problems. However, most people with type 1 diabetes who
experience such symptoms do not receive professional help. This can have multiple reasons.
Oftentimes, the problems are not severe enough to be classified as a disorder. Some people
also prefer to work on the problems on their own, at their own pace. For people who
experience mental health problems around their diabetes and to support them individually with
as little barriers as possible, MyDiaMate was developed.
Objective: To investigate the effectiveness of MyDiaMate in reducing mental health problems
in adults with type 1 diabetes who experience distress related to their disease across four
countries (NL, DE, UK, ES).
Study design and procedure: Multi-national randomised-controlled trial (intervention :
wait-list control group, randomised 2:1 per country).
After screening has confirmed study participation, participants will:
Complete the baseline assessment and be randomisation afterwards
Use MyDiaMate for 3 months in case of intervention group membership, or get care as
usual in case of waitlist control group membership
At 3 months, all participants fill in the first follow-up assessment. Additionally,
intervention group members will be asked about their satisfaction with and opinion on
MyDiaMate (questionnaire and interviews).
All participants then receive access to MyDiaMate for the remaining 3 months of the
study.
At 6 months, all participants complete the second follow-up assessment. Afterwards, the
study ends for all participants and access to MyDiaMate is revoked.
Study population: Adults with type 1 diabetes who have been diagnosed more than 6 months ago
and who experience distress in relation to their type 1 diabetes.
Intervention: The intervention group receives access to the online self-help programme
MyDiaMate for 6 months. MyDiaMate is focused on mental health in type 1 diabetes. It includes
psychoeducation and teaches coping strategies that are based on cognitive-behavioural therapy
concepts. Moreover, videos in which people with type 1 diabetes talk about their experiences
in coping with the disease are embedded in MyDiaMate. MyDiaMate users can also choose to make
use of diaries and a module that helps with setting realistic goals. MyDiaMate can be
accessed via a private mobile phone, tablet, or laptop/computer whenever wished. Because
MyDiaMate is self-help, there is no schedule in when/how much participants should access
MyDiaMate. Participants can make use of MyDiaMate as much as they want to, in a way that
suits them best personally. Members in the waitlist control group receive access to MyDiaMate
after 3 months, for 3 months, if so wished. They too can make use of MyDiaMate in a way that
fits their personal time and needs best.
Main study parameters/endpoints: The main study outcome is change in diabetes distress in the
intervention group between the baseline and the 3 months assessment. Secondary study outcomes
are changes in emotional well-being, psychological self-efficacy in relation to diabetes,
social engagement, and fatigue between the baseline and the 3 months assessment in
participants from the intervention group. Moreover, in line with the secondary objective, the
investigators will make use of MyDiaMate log data such as time spent in MyDiaMate and
frequency of use in participants of the intervention group across the first 3 months and
investigate in relation to the main and secondary outcomes as well as descriptive data such
as age or gender, for which subgroup of MyDiaMate users the application programme is most
effective.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: There are no risks related to use of MyDiaMate. The burden of study
participation is low, as participants are not instructed to use MyDiaMate in a certain
way/intensity and filling in the non-invasive study questionnaires takes around 2 hr in total
and is spread across 6 months. Both the intervention and control group have access to
MyDiaMate during study participation (for 6 months in case of intervention group membership,
for 3 months after 3 months in case of wait-list control group membership). Study
participants benefit from study participation because they receive access to MyDiaMate, which
may possibly help them with improving the diabetes-related mental health and teaches a
variety of type 1 diabetes specific coping strategies, all of which is based on
well-researched concepts of psychoeducation and cognitive behavioural therapy.