Headspace Mindfulness App Trial

September 6, 2017 updated by: Tom Elliott, BCDiabetes.Ca

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Headspace Application Treatment Group
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
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.
No Intervention: Standard Care Control Group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Assessed with Diabetes Distress Screening Scale
3 months
Social support
Time Frame: 3 months
Assessed with Diabetes Distress Screening Scale
3 months
Diabetes empowerment
Time Frame: 3 months
Assessed with Diabetes Distress Screening Scale
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BCDiabetes.Ca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BCDiabetes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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