Pilot online-MBI to improve T1D-related outcomes
Research type
Research Study
Full title
Development and pilot testing of an online mindfulness-based intervention for improving fear of hypoglycaemia, well-being and self-management in adults with Type 1 diabetes
IRAS ID
295448
Contact name
Kate Landowska
Contact email
Sponsor organisation
Royal Holloway, University of London
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Research Summary
Hypoglycaemia occurs in people with type 1 diabetes (T1D) when blood glucose levels drop too low and results in symptoms such as sweating, shakiness, and disorientation. Fear of hypoglycaemia (FOH) is a common response to the risk of hypoglycaemia and can lead to poor diabetes self-management (Davis, 2004). For example, patients may try to keep their blood sugar levels high to avoid experiencing hypoglycaemia. Despite the development of technologies to support people in managing their blood glucose levels, these developments have not translated to reduced FOH in adults with T1D (Davey, 2012).Many NHS diabetes services do not include access to diabetes-specific psychological support due to funding limitations (Diabetes UK, 2008). It is important to target this gap by developing tailored interventions which are financially feasible and accessible.
Mindfulness-based interventions (MBIs) have been found to improve psychological outcomes among people with Type 1 and Type 2 diabetes including diabetes-related distress, depression and anxiety (Whitebird, 2018). Lower mindful parenting is also related to greater FOH in parents of children with T1D (Aaalders et al., 2018).
There are, however, no studies which have examined whether mindfulness is associated with reduced FOH in adults with T1 diabetes. The aim of the present study is to develop and test the acceptability, feasibility and preliminary effectiveness of a brief (4-week) online MBI in reducing FOH and improving diabetes self-management and well-being in a sample of adults with T1D. Participants will be recruited from NHS diabetes care services at Charing Cross Hospital and Barts.
We hypothesise: (1) the MBI will lead to significant changes in FOH, wellbeing and diabetes self-management (2) scores on the state mindfulness measure will increase during the intervention (3) there will be clinically significant changes in FOH, well-being and diabetes self-management at follow-up.
Summary of Results
Type 1 diabetes (T1D) is a long-term health condition affecting approximately 1 in 250 people. In this condition, the body produces little or no insulin, which is a hormone used to break down sugar (or ‘glucose’) in the blood. People with T1D therefore need to self-administer insulin. If blood glucose levels drop to low, a reaction known as ‘hypoglycaemia’ can take place. Hypoglycaemia can lead to physical symptoms such as shakiness, sweating and fatigue. It can also lead to difficulty thinking clearly which can result in individuals making mistakes, having accidents or getting physical injuries. In response to the risk of hypoglycaemia, some people with T1D reasonably develop a fear towards this reaction, known as ‘fear of hypoglycaemia’ (FOH). They may do certain behaviours to avoid hypoglycaemia such as eating sugary snacks or taking too little insulin so that there is more glucose in the bloodstream. This can be harmful as high blood glucose levels can lead to long-term health complications caused by damage to the person’s blood vessels and nerves which can particularly affect the heart, eyes, feet and kidneys.There are different education courses to support people with T1D. Courses include Blood Glucose Awareness Training (BGAT) and Dose Adjustment for Normal Eating (DAFNE). These are normally run in groups and help to educate people on how to manage their diabetes and to keep blood glucose at ideal levels. People with T1D can also access psychological interventions such as Cognitive Behavioural Therapy (CBT) which can help to reduce anxiety by challenging negative thoughts and changing behaviours.
Research has shown that current psychological and educational interventions are limited in reducing FOH. BGAT is the most promising approach showing some reductions in worries associated with FOH. It was therefore recommended that future research should develop and test new approaches to help people with FOH. BGAT may be effective because it helps people to be more in tune with their body and therefore understand the difference between symptoms of hypoglycaemia, symptoms of anxiety and normal bodily sensations. Interventions which also target the mind-body link could be effective.
Building on this finding, an online mindfulness-based intervention (MBI) was developed and assessed in an experimental pilot study. Mindfulness supports people to be more aware of what they’re sensing and feeling in the moment, without interpretation or judgment. Research has found it is associated with FOH in parents of children with T1D. MBIs have also been found to improve well-being and diabetes-self management in people with T1D. The aims of the project were to assess whether an online MBI targeted at FOH could (1) help to reduce FOH, (2) improve well-being and diabetes self-management, and (3) be acceptable and feasible for use in a T1D population.
The course was delivered online and was co-developed with two experts by experience. Six volunteers with T1D, who were experiencing FOH were recruited through two NHS diabetes services, charity support groups and social media. They were randomly assigned to a wait time of 1, 2 or 3 weeks before accessing the online course. The volunteers completed four modules of the mindfulness course over four weeks and were encouraged to practice mindfulness in between modules. At the end there was a 4-week period to see if improvements were maintained over time.
Throughout their involvement, participants were asked to complete simple daily questions which asked about FOH, diabetes self-management behaviours and well-being. They were also asked to complete longer questionnaires at the start, after the course and after the 4-week wait. Their answers were analysed to see if there were any differences in outcomes before and after the course.
It was found that:
Of the people who were eligible and signed up for the study, 43% completed it, suggesting that the online course may not be feasible for everyone.
Completers gave feedback to say that the course was user-friendly and that it helped them effectively deal with their problems.
Most participants found they had less anxiety about hypoglycaemia after doing the course, with changes maintained at follow-up.
Most participant’s well-being also improved after engaging in the mindfulness course.
Mindfulness increased for most participants during the course.
Self-management behaviours did not improve overall, although there were positive changes in blood glucose management for some participants.Altogether the study suggests that MBIs may offer a low-cost way to support people with T1D. This could help to fill a gap in services, as there are currently no targeted interventions for this presentation. It is recommended that future research builds on these results by testing the online MBI in a larger trial with more participants. In order for results to reach a wide audience, they will be made available to participants, shared on social media accounts of diabetes support groups and published in a scientific journal.
REC name
Wales REC 3
REC reference
21/WA/0218
Date of REC Opinion
15 Sep 2021
REC opinion
Further Information Favourable Opinion