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临床试验/NCT03104608
NCT03104608Unknown不适用

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

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
Change in Health Related Quality of Life (HRQoL)

研究概览

简要总结

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.

详细描述

OBJECTIVE: The investigators key objective is to study the effects of ASTM on HRQoL, depression, and anxiety in AMD patients. The second objective is to determine if there is an association between HRQoL, depression, and anxiety with routinely measured clinical variables. A mathematical model to compute HRQoL, depression, and anxiety from ophthalmic clinical variables will be developed in ASTM plus TAU as well as TAU alone group.

Study Design: The investigators plan to conduct a single-center, single blind longitudinal randomized controlled trial (RCT). Research participants will be 140 men and women (70 in each group).

Study Recruitment: Potential participants with severe AMD above 50 years of age will be screened - from the office practice of Dr. Mao as per inclusion and exclusion criteria at the Ivey Eye Institute, London, ON.

An ophthalmic examination - offered as a routine care - for each potential participant (i.e., measuring best-corrected Snellen visual acuity and pinhole acuities) will be conducted. Snellen acuity will be converted to LogMAR according to visual angle subtended by letters such as 20/20 = 0.0, 20/40 = 0.3, 20/50 = 0.3978. A value above 20/200 = 1.0 will be assigned to counting fingers, hand motions, and light perception. No light perception will receive a value of 0.0.

Questionnaire: Patients will undergo a standardized interview performed by a trained interviewer to measure HRQoL 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 to their current vision in each eye to be transformed to permanent perfect vision (20/20) bilaterally?. During the first office visit (screening visit), in the interview, patients will be asked demographic questions including age, gender, and associated medical conditions, such as concurrent ocular conditions, ocular disease other than AMD, previous ocular surgery, intraoperative complications, preoperative ocular pathology, chronic pain, general diseases that could affect the immune system, and actual infection. In addition, patients will be asked about co-morbidities such as, whether they have high blood pressure, diabetes, arthritis, heart condition, stroke, and other non-ocular medical conditions. Further, the following self-rated scales will be administered at the first office visit: TTO, Visual Function Questionnaire (VFQ-25), the Patient Health Questionnaire (PHQ-9), and Generalized Anxiety Disorder (GAD-7).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

干预措施: Automatic Self Transcending Meditation (Other)

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.

干预措施: Treatment as Usual (Other)

结局指标

主要结局

Change in Health Related Quality of Life (HRQoL)

时间窗: Change from baseline up to 24 weeks

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?.

次要结局

  • Change in Anxiety score(Change from baseline up to 24 weeks)
  • Change in Vision Score(Change from baseline up to 24 weeks)
  • Change in Depression score(Change from baseline up to 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monali Malvankar

Assistant Professor

Lawson Health Research Institute

研究点 (2)

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