Diabetes Mellitus Clinical Trial
Official title:
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
The study is a prospective, randomized, non-blinded comparative group clinical trial comparing participants who receive access to a mindfulness software app, Headspace, to those who receive standard care (i.e., a list of resources on mindfulness and health). It is hypothesized that participants randomized to the Headspace mindfulness application will exhibit greater improvement in HbA1C and quality of life measures compared to those randomized to standard care.
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.
Participants randomized to mindfulness app group will be given 3 months of free access to
Headspace, a digital service that provides guided meditation sessions and mindfulness
training. Headspace consists of video sessions on the foundations of mindfulness, health,
relationships and performance. Participants randomized to standard care will not receive
Headspace, but instead, a list of resources on mindfulness and health, until the 3-month
study is complete.
At the 3-month visit, participants in both groups will have HbA1C taken and quality of life
questionnaire completed. No further data will be collected after the final 3-month visit. At
this time, participants in the control group will receive the same 3-month access to
Headspace as if the participants had been randomized to the treatment group, for equality
purposes.
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