Automatic Self Transcending Meditation (ASTM) Versus Usual Care in Patients With Glaucoma

NCT03086980 | Unknown DMC

• 1 other identifier: 108387
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

health related quality of life; utility; regression

Outcome Measures

Primary Outcomes (1)

• Change in Health-related quality of life (HRQoL)

  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.

  First office visit, Week 0, 4, 6, 8, 12, and 24

Secondary Outcomes (3)

• Visual Function Score

  First office visit, Week 0, 4, 6, 8, 12, and 24

• Depression

  First office visit, Week 0, 4, 6, 8, 12, and 24

• Anxiety

  First office visit, Week 0, 4, 6, 8, 12, and 24

Study Arms (2)

Automatic Self Transcending Meditation

ACTIVE COMPARATOR

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.

Other: Automatic Self Transcending Meditation

Treatment as Usual (TAU)

PLACEBO COMPARATOR

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.

Other: Treatment as Usual

Interventions

Automatic Self Transcending Meditation OTHER

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.

Also known as: Sahaj Samadhi Meditation

Automatic Self Transcending Meditation

Treatment as Usual OTHER

Usual Care will be provided.

Also known as: Usual Care

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

RECRUITING

Related Publications (4)

• Skalicky S, Goldberg I. Depression and quality of life in patients with glaucoma: a cross-sectional analysis using the Geriatric Depression Scale-15, assessment of function related to vision, and the Glaucoma Quality of Life-15. J Glaucoma. 2008 Oct-Nov;17(7):546-51. doi: 10.1097/IJG.0b013e318163bdd1.

  PMID: 18854731 BACKGROUND

• Pappa C, Hyphantis T, Pappa S, Aspiotis M, Stefaniotou M, Kitsos G, Psilas K, Mavreas V. Psychiatric manifestations and personality traits associated with compliance with glaucoma treatment. J Psychosom Res. 2006 Nov;61(5):609-17. doi: 10.1016/j.jpsychores.2006.03.050.

  PMID: 17084138 BACKGROUND

• Burns JL, Lee RM, Brown LJ. The effect of meditation on self-reported measures of stress, anxiety, depression, and perfectionism in a college population. Journal of College Student Psychotherapy 25(2):132-144, 2011.

  BACKGROUND

• Schneider RH, Alexander CN, Staggers F, Rainforth M, Salerno JW, Hartz A, Arndt S, Barnes VA, Nidich SI. Long-term effects of stress reduction on mortality in persons > or = 55 years of age with systemic hypertension. Am J Cardiol. 2005 May 1;95(9):1060-4. doi: 10.1016/j.amjcard.2004.12.058.

  PMID: 15842971 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Monali Malvankar, PhD

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 22, 2017
• Study Start: August 1, 2017
• Primary Completion: July 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)