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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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BCDiabetes.Ca |
Bradley C. Stress and diabetes. Handbook of Life Stress, Cognition and Health. New York: John Wiley & Sons 1988:383-401.
Bränström 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. — View Citation
Haenen S, Nyklícek 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. — View Citation
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. Review. Erratum in: Diabetes Care. 2013 May;36(5):1429. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999 May-Jun;15(3):205-18. Review. — View Citation
Segal ZV, Williams JMG, Teasdale JD. Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse. New York, Guilford Press, 2002.
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. — View Citation
van Son J, Nyklícek 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin A1C | A hypothesized reduction in HbA1C by 3 months post-randomization in participants in the treatment group compared to control group. | 3 months | |
Primary | 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 | Medication adherence | Assessed with Diabetes Distress Screening Scale | 3 months | |
Secondary | Social support | Assessed with Diabetes Distress Screening Scale | 3 months | |
Secondary | Diabetes empowerment | Assessed with Diabetes Distress Screening Scale | 3 months |
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