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.
