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

NCT03104608 | Unknown

• 1 other identifier: 10016731
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-related Macular Degeneration; Low Vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Vision Score

  Change from baseline up to 24 weeks

• Change in Depression score

  Change from baseline up to 24 weeks

• Change in Anxiety score

  Change from baseline up to 24 weeks

Study Arms (2)

Automatic Self Transcending Meditation

ACTIVE COMPARATOR

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).

Other: Automatic Self Transcending Meditation

Treatment as Usual

PLACEBO COMPARATOR

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.

Other: Treatment as Usual

Interventions

Automatic Self Transcending Meditation OTHER

Automatic Self Transcending Meditation 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. Research suggests that ASTM is easier to learn and to teach in comparison to other meditation techniques. Further, studies have shown that ASTM confers large effect sizes as an anti-depressant.

Automatic Self Transcending Meditation

Treatment as Usual OTHER

Participants randomized to Treatment as Usual (TAU)) will continue to receive their treatment as usual.

Treatment as Usual

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

Location

Related Publications (1)

• 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. eCollection 2016.

  PMID: 27414030 RESULT

MeSH Terms

Conditions

Macular Degeneration; Vision, Low

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monali Malvankar

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Malvankar, PhD

CONTACT

5196858500; monali.malvankar@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)