Depression Clinical Trial
Official title:
Automatic Self Transcending Meditation (ASTM) Plus Treatment As Usual (TAU) Versus TAU Alone in Patients With Dry Eye Disease (DED): a Single Blind Randomized Controlled Longitudinal Study
Patients with dry eye disease (DED) will be randomized to Automatic Self Transcending Meditation (ASTM) plus Treatment as Usual (TAU) or TAU alone to assess changes in Health-related quality of life (HRQoL). HRQoL is a vital construct focusing on impact of health on quality of life. HRQoL data is used in economic evaluations, a component of health economics that compares the cost and consequences of alternative courses of action. This helps policy-makers make complex financial decisions. Along with HRQoL we will measure changes in extent of depression as well as anxiety. Previously published data lacks information of HRQoL in patients with DED. Through this study we shall attempt to correlate HRQoL in this population and assess if ASTM confers changes in HRQoL along with depressive and anxiety symptoms.
Status | Not yet recruiting |
Enrollment | 256 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - dry eye disease suspects or have mild to severe dry eye disease - at least between 18 to 75 years of age - deemed competent such as no language issues or communication barriers, no self-reported or physician diagnosed mental health disorder besides having depressive and anxiety symptoms - have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes - willing and able to attend 4 initial ASTM training sessions and at least 80% of follow up sessions - willing to dedicate 20 minutes twice per day to ASTM practice at their own home. Exclusion Criteria: - actively suicidal as per self-report (scoring 2 or more on item 9 of the PHQ-9) or on assessment by the physician - they are currently participating in other similar studies - currently practicing any type of formal meditation techniques regularly - unable or unwilling to answer survey questions. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Hospital, Ivey Eye Institute | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Burns JL., Lee RM, Brown LJ. The effect of meditation on self-reported measures of stress, anxiety, depression, and perfectionism in a college population. Journal of College Student Psychotherapy 25(2): 132-144, 2011.
Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102. — View Citation
Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103. — View Citation
Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. — View Citation
Schein OD, Muñoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. — View Citation
Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12. Review. — View Citation
Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Health-related quality of life (HRQoL) | HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire. | First office visit, Week 0, 4, 6, 8, 12, and 24 | |
Secondary | Visual Function Score | Visual Function score will be measured using Visual Function Questionnaire (VFQ-25). | First office visit, Week 0, 4, 6, 8, 12, and 24 | |
Secondary | Depression | Depression is a feeling of severe despondency and dejection. Depression will be measured using the Patient Health Questionnaire (PHQ-9). | First office visit, Week 0, 4, 6, 8, 12, and 24 | |
Secondary | Anxiety | Anxiety will be measured using Generalized Anxiety Disorder (GAD-7) | First office visit, Week 0, 4, 6, 8, 12, and 24 | |
Secondary | Dry Eye Assesment | Dry Eye will be assessed using Canadian Dry Eye Assessment (CDEA), Ocular Surface Disease Index (OSDI), SPEED Dry Eye Questionnaire | First office visit, Week 0, 4, 6, 8, 12, and 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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