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Trial record 90 of 8464 for:    Ophthalmopathy

Automatic Self Transcending Meditation (ASTM) in Patients With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03087006
Recruitment Status : Not yet recruiting
First Posted : March 22, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Monali Malvankar, Lawson Health Research Institute

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Anxiety [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]
    Anxiety will be measured using Generalized Anxiety Disorder (GAD-7)

  4. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Monali Malvankar, PhD 5196858500 ext 61288 monali.malvankar@sjhc.london.on.ca

Locations
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Canada, Ontario
St. Joseph's Hospital, Ivey Eye Institute Not yet recruiting
London, Ontario, Canada, N6G0H8
Contact: Jordan Miller, BSc.    519-646-6100 ext 52492    jordan.miller@sjhc.london.on.ca   
Sub-Investigator: Rookaya Mather, MD         
Sub-Investigator: Akshya Vasudev, MD         
Sub-Investigator: Sunil Parapuram, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Monali Malvankar, PhD University of Western Ontario, Canada

Publications:
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Responsible Party: Monali Malvankar, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03087006     History of Changes
Other Study ID Numbers: 108461
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified IPD collected in this study will not be available to other researchers (e.g. outside the primary research group). Because the primary research group has the necessary expertise to conduct analysis and do not need any outside help.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eye Diseases