Headspace Mindfulness App Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Headspace Mindfulness App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides full informed consent to participate in the study Established diagnosis of diabetes mellitus according to Canadian Diabetes Association criteria at the time of screening for the study Has an age ≥12 years Has a most recent HbA1C measurement of ≥8% Has access to an electronic device that supports Headspace (i.e., tablet or smart phone) Exclusion Criteria: Has a most recent HbA1C measurement of <8% Has a physical disability or psychiatric diagnosis which would limit the ability to adhere to the study regimen, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will use a parallel study model that consists of a treatment arm (ie. Headspace mindfulness app group) and a control arm (ie. standard care where patients receive a list of resources on mindfulness and health).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headspace Application Treatment Group<br>Participants in the treatment group will be given a free 3-month access code to Headspace. The app contains a series of sessions that guide the user through mindfulness training. | Behavioral: Headspace Mindfulness App<br>* Participants will be given instructions on how to download Headspace on an electronic device and will be provided a free 3-month access code. The app contains a series of ten step-wise 10-minute video sessions that guide the user through mindfulness training. Upon completion of these sessions, additional content will be accessible, including sessions on health (depression, self-esteem, anxiety, sleep, and pregnancy), relationships (kindness, generosity, relationships, change, appreciation, and acceptance) and performance (creativity, focus, happiness, and balance). The frequency and duration of usage will be in accordance to the instructions of the app.<br>|
| No Intervention: Standard Care Control Group<br>Participants in the control group will be provided a list of resources that provides guidance on mindfulness and general health. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | A hypothesized reduction in HbA1C by 3 months post-randomization in participants in the treatment group compared to control group. | 3 months | 
| Quality of life | A hypothesized improvement in quality of life measurements, assessed by SD36 questionnaire, by 3 months post-randomization in participants in the treatment group compared to control group. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Assessed with Diabetes Distress Screening Scale | 3 months | 
| Social support | Assessed with Diabetes Distress Screening Scale | 3 months | 
| Diabetes empowerment | Assessed with Diabetes Distress Screening Scale | 3 months |