Evaluating the Effectiveness of Headspace Mindfulness Application Versus Standard Care on the HbA1C and Quality of Life in Patients With Diabetes: A Randomized Control Trial

Stress has been associated with diabetes mellitus, and is believed to both precipitate the onset and disrupt the control of diabetes. The overall quality of life, measured as physical and social functioning and perceived as physical and mental well-being, has been shown to be adversely impacted in those living with diabetes compared to people with no chronic illness. Both the physiological effects of poorly managed diabetes and the psychological stress of dealing with chronic illness can have negative tolls on the physical, social and mental well-being of the patient.

Although the emotional problems in diabetic patients have received increasing attention in the recent decade, these issues often remain unrecognized in clinical practice and untreated. Previous research suggest that antidepressant medication and cognitive behavioral therapy can be effective in the treatment of major depression in a proportion of diabetic patients; however, the use of these medications is often accompanied by side effects, lack of response to medication, or relapse. One accessible group intervention that proved successful in reducing emotional distress and improving quality of life in nonpatients and patient groups is mindfulness-based cognitive therapy. The central component of such intervention is the cultivation of mindfulness.

Mindfulness, the mental state of awareness of internal and external experiences, has been used as a technique in numerous types of therapies. Previous studies suggested that increased levels of mindfulness through mindfulness-based cognitive therapy mediated the effects of inventions on depressed and angry mood and stress in diabetes outpatients. Practice of mindfulness, such as meditation, has indicated correlation with well-being and perceived health, and that dispositional mindfulness may buffer against the negative impact of perceived stress on psychological well-being. Furthermore, mindfulness may be associated with better glucose regulation in diabetics, as individuals with higher levels of mindfulness may have a lower likelihood of obesity and greater sense of control. Hence, the role of mindfulness in the management of diabetes warrants further investigations.

A promising digital health platform, Headspace, provides guided meditation sessions, mindfulness training, meditation resources via a software application. Headspace has already been used in a number of clinical trials exploring the effects of mindfulness training. For instance, one study examining the impact of mindfulness on workplace stress found significant increases in well-being and perceived job control, and reductions in anxiety, depressive symptoms, diastolic blood pressure and sleep problems.

The objective of this study is to determine the effectiveness of using the Headspace mindfulness application compared to the standard care of providing resources on mindfulness to patients with diabetes. Specifically, the study will test the hypothesis that participants randomized to the Headspace app group will exhibit greater improvement in HbA1C and quality of life measures compared to those randomized to standard care.