Recruiting

ASTM vs. Usual Care

Sponsor:

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

Code:

NCT03086980

Conditions

Glaucoma

Depression

Anxiety

Quality of Life

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Automatic Self Transcending Meditation

Treatment as Usual

Study Details

Brief summary:

Patients with glaucoma 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 glaucoma. 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.

Conditions

Glaucoma

Depression

Anxiety

Quality of Life

Study ID

NCT03086980

Start date

Aug 1, 2017

Status verified date

Aug, 2017

Completion date

Dec 1, 2019

Anticipated

Primary completion date

Jul 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • glaucoma suspects or have mild to severe glaucoma
  • at least 18 years of age or above
  • 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 and 80% of bi-weekly 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, mindfulness or breathing techniques regularly
  • unable or unwilling to answer survey questions.

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Automatic Self Transcending Meditation

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 may help reduce depression and anxiety.

placebo comparator: Treatment as Usual (TAU)

The usual standard of care for patients with glaucoma includes starting them on first line of drugs. Participants will be initiated and maintained on appropriate dosages of such medications as part of standard of care. The usual standard of care also includes an ophthalmic examination measuring best-corrected Snellen VA and pinhole acuities and a follow-up visit once a year.

Interventions

Automatic Self Transcending Meditation

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.

Treatment as Usual

Usual Care will be provided.

Primary outcome measure

  • Change in Health-related quality of life (HRQoL) [ Time Frame: First office visit, Week 0, 4, 6, 8, 12, and 24 ]

Central Contacts and Locations

Central contacts

Monali Malvankar, PhD

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

Locations

St. Joseph's Hospital, Ivey Eye Institute

Recruiting

London, Ontario, Canada, N6G0H8

Contacts

Jordan Miller, BSc.

519-646-6100jordan.miller@sjhc.london.on.ca

More Information

Sponsor

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

Last update posted

Aug 24, 2017

Last verified

Aug, 2017

Keywords

  • health related quality of life
  • utility
  • regression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2017-08-24.