Automatic Self Transcending Meditation (ASTM) in Patients With Dry Eye Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03087006|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2017
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Eye Diseases Quality of Life Depression Anxiety||Other: Automatic Self Transcending Meditation (ASTM) Other: Treatment as Usual||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|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|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Active Comparator: Automatic Self Transcending Meditation
Automatic Self Transcending Meditation (ASTM) may help with depression, anxiety, stress, PTSD, and may have a positive impact on quality of life of participants diagnosed with dry eye disease. ASTM is a class of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness.
Other: Automatic Self Transcending Meditation (ASTM)
Automatic Self Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind. Research suggests that ASTM helps reduce depression, anxiety, stress, and may improve health related quality of life. Further, ASTM is easier to learn and to teach.
Other Name: Meditation
Placebo Comparator: Treatment as Usual (TAU)
Participants continue to receive treatment as usual including dry eye disease medications.
Other: Treatment as Usual
Usual Care includes usual care of the participants including dry eye disease medications
Other Name: Primary Care
- Change in Health-related quality of life (HRQoL) [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]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.
- Visual Function Score [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]Visual Function score will be measured using Visual Function Questionnaire (VFQ-25).
- Depression [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]Depression is a feeling of severe despondency and dejection. Depression will be measured using the Patient Health Questionnaire (PHQ-9).
- Anxiety [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]Anxiety will be measured using Generalized Anxiety Disorder (GAD-7)
- Dry Eye Assesment [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]Dry Eye will be assessed using Canadian Dry Eye Assessment (CDEA), Ocular Surface Disease Index (OSDI), SPEED Dry Eye Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087006
|Contact: Monali Malvankar, PhD||5196858500 ext firstname.lastname@example.org|
|St. Joseph's Hospital, Ivey Eye Institute||Not yet recruiting|
|London, Ontario, Canada, N6G0H8|
|Contact: Jordan Miller, BSc. 519-646-6100 ext 52492 email@example.com|
|Sub-Investigator: Rookaya Mather, MD|
|Sub-Investigator: Akshya Vasudev, MD|
|Sub-Investigator: Sunil Parapuram, PhD|
|Principal Investigator:||Monali Malvankar, PhD||University of Western Ontario, Canada|