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Automatic Self Transcending Meditation (ASTM) for Patients With Severe Age Related Macular Degeneration (AMD)

N/A
Waitlist Available
Led By Monali Malvankar
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline up to 24 weeks

Summary

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.

Eligible Conditions
  • Low Vision
  • Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Health Related Quality of Life (HRQoL)
Secondary study objectives
Change in Anxiety score
Change in Depression score
Change in Vision Score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Automatic Self Transcending MeditationActive Control1 Intervention
Participants in the ASTM group will undergo training in groups of 10 by certified teachers. Further, the following self-rated scales will be administered by a trained rater at the fourth ASTM session (week 0) as well as at weeks 4, 8, 12, and 24: Time Trade-off (TTO), Visual Function Questionnaire (VFQ-25), the Patient Health Questionnaire (PHQ-9), and Generalized Anxiety Disorder (GAD-7).
Group II: Treatment as UsualPlacebo Group1 Intervention
Participants will continue to receive their treatment as usual. The following self-rated scales will be administered by a trained rater at weeks 0, 4, 8, 12 and 24: TTO, VFQ-25, PHQ-9, and GAD-7.

Find a Location

Who is running the clinical trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
615 Previous Clinical Trials
405,258 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,280 Total Patients Enrolled
Monali MalvankarPrincipal InvestigatorWestern University, Canada
3 Previous Clinical Trials
645 Total Patients Enrolled
~19 spots leftby Dec 2025