Headspace Mindfulness App Trial

NCT03274362 | Unknown

• 1 other identifier: BCDiabetes
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Medication adherence

  3 months

• Social support

  3 months

• Diabetes empowerment

  3 months

Study Arms (2)

Headspace Application Treatment Group

EXPERIMENTAL

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

Standard Care Control Group

NO INTERVENTION

Participants in the control group will be provided a list of resources that provides guidance on mindfulness and general health.

Interventions

Headspace Mindfulness App BEHAVIORAL

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.

Headspace Application Treatment Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BCDiabetes.Ca: lead

Related Publications (11)

• Bradley C. Stress and diabetes. Handbook of Life Stress, Cognition and Health. New York: John Wiley & Sons 1988:383-401.

  BACKGROUND

• Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999 May-Jun;15(3):205-18. doi: 10.1002/(sici)1520-7560(199905/06)15:33.0.co;2-o.

  PMID: 10441043 BACKGROUND

• Kan C, Silva N, Golden SH, Rajala U, Timonen M, Stahl D, Ismail K. A systematic review and meta-analysis of the association between depression and insulin resistance. Diabetes Care. 2013 Feb;36(2):480-9. doi: 10.2337/dc12-1442.

  PMID: 23349152 BACKGROUND

• Tunceli K, Bradley CJ, Nerenz D, Williams LK, Pladevall M, Elston Lafata J. The impact of diabetes on employment and work productivity. Diabetes Care. 2005 Nov;28(11):2662-7. doi: 10.2337/diacare.28.11.2662.

  PMID: 16249536 BACKGROUND

• Pouwer F, Beekman AT, Lubach C, Snoek FJ. Nurses' recognition and registration of depression, anxiety and diabetes-specific emotional problems in outpatients with diabetes mellitus. Patient Educ Couns. 2006 Feb;60(2):235-40. doi: 10.1016/j.pec.2005.01.009.

  PMID: 16442465 BACKGROUND

• Pouwer F. Should we screen for emotional distress in type 2 diabetes mellitus? Nat Rev Endocrinol. 2009 Dec;5(12):665-71. doi: 10.1038/nrendo.2009.214. Epub 2009 Nov 3.

  PMID: 19884900 BACKGROUND

• Segal ZV, Williams JMG, Teasdale JD. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse. New York, Guilford Press, 2002.

  BACKGROUND

• Haenen S, Nyklicek I, van Son J, Pop V, Pouwer F. Mindfulness facets as differential mediators of short and long-term effects of Mindfulness-Based Cognitive Therapy in diabetes outpatients: Findings from the DiaMind randomized trial. J Psychosom Res. 2016 Jun;85:44-50. doi: 10.1016/j.jpsychores.2016.04.006. Epub 2016 Apr 22.

  PMID: 27212669 BACKGROUND

• van Son J, Nyklicek I, Pop VJ, Blonk MC, Erdtsieck RJ, Spooren PF, Toorians AW, Pouwer F. The effects of a mindfulness-based intervention on emotional distress, quality of life, and HbA(1c) in outpatients with diabetes (DiaMind): a randomized controlled trial. Diabetes Care. 2013 Apr;36(4):823-30. doi: 10.2337/dc12-1477. Epub 2012 Nov 27.

  PMID: 23193218 BACKGROUND

• Branstrom R, Duncan LG, Moskowitz JT. The association between dispositional mindfulness, psychological well-being, and perceived health in a Swedish population-based sample. Br J Health Psychol. 2011 May;16(Pt 2):300-16. doi: 10.1348/135910710X501683. Epub 2011 Mar 8.

  PMID: 21489058 BACKGROUND

• Loucks EB, Gilman SE, Britton WB, Gutman R, Eaton CB, Buka SL. Associations of Mindfulness with Glucose Regulation and Diabetes. Am J Health Behav. 2016 Mar;40(2):258-67. doi: 10.5993/AJHB.40.2.11.

  PMID: 26931758 BACKGROUND

Related Links

• Current 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tom G Elliott, MBBS

CONTACT

604-683-3734; telliott@bcdiabetes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is a prospective, randomized, non-blinded comparative group clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: 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).

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 6, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09