Age-related Macular Degeneration Clinical Trial
Official title:
Automatic Self Transcending Meditation (ASTM) Plus Treatment As Usual (TAU) Versus TAU Alone in Patients With Severe Age Related Macular Degeneration (AMD), a Single Blind Randomized Controlled Longitudinal Study
Age-related macular degeneration (AMD) is a condition affecting 20 to 25 million people worldwide. Symptoms of AMD includes difficulty in reading, recognizing faces and completing house work which may result in increased disability which in turn increase symptoms of depression and anxiety. Depression and anxiety could also be worsened by social isolation caused by AMD. Further, AMD causes high levels of emotional distress and reduced quality of life (QoL). Automatic Self Transcending Meditation (ASTM) - a standardized category of meditation - may help reduce stress, depression, anxiety, and may enhance QoL. Automatic Self Transcending Meditation (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. In the proposed research, the effects of ASTM on health related quality of Life (HRQoL), depression and anxiety in low-vision AMD patients will be studied. A single-center, single-blind longitudinal randomized controlled trial (RCT) will be conducted in London, ON. Patients with AMD (n = 140, 70 in each arm) will be randomized to ASTM plus treatment as usual (TAU) or TAU alone (control) arm. Data on routinely measured ophthalmic clinical variables, HRQoL, depression, and anxiety will be collected from both the arms. Statistical analysis will be conducted using STATA 15.0 to evaluate the effects of ASTM plus TAU compared to TAU alone on HRQoL, depression, and anxiety. Further, for each group - ASTM plus TAU and TAU alone - the investigators develop an association between HRQoL, depression, and anxiety with routinely measured clinical variables using mathematical models.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | December 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - at least 50 years of age, - have severe AMD - 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 75% of weekly, bi-weekly and monthly 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 Patient Health Questionnaire (PHQ-9) or on assessment by the physician - they are currently participating in other similar studies - currently practicing any type of formal meditation 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,
Hamade N, Hodge WG, Rakibuz-Zaman M, Malvankar-Mehta MS. The Effects of Low-Vision Rehabilitation on Reading Speed and Depression in Age Related Macular Degeneration: A Meta-Analysis. PLoS One. 2016 Jul 14;11(7):e0159254. doi: 10.1371/journal.pone.0159254 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Health Related Quality of Life (HRQoL) | HRQoL is measured using the time trade-off method (TTO) in which potential participants will be asked couple of questions about their quality of life such as 1) how long participant expect to live? and 2) how many of those remaining years of life, if any, participant would be willing to trade in return for a treatment permitting your current vision in each eye to be transformed to permanent perfect vision (20/20) bilaterally?. | Change from baseline up to 24 weeks | |
Secondary | Change in Vision Score | Visual Function Questionnaire (VFQ-25) will be used to measure vision score | Change from baseline up to 24 weeks | |
Secondary | Change in Depression score | Patient Health Questionnaire (PHQ-9) will be used to measure depression score | Change from baseline up to 24 weeks | |
Secondary | Change in Anxiety score | Generalized Anxiety Disorder (GAD-7) will be used to measure anxiety score | Change from baseline up to 24 weeks |
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