DepressionNCT03345381
Impact of Breathing Exercises and Meditation on Quality of Life in Dry Eye Disease Patients: A Pilot Study
A study of Depression and Quality of Life, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Quality of Life, Dry Eye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dry eye disease suspects or have mild to severe dry eye disease
- at least between 18 to 80 years of age
- 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 3 initial SKY and 4 initial ASTM training sessions
- willing to dedicate 20 minutes per day for SKY and 20 minutes twice per day to ASTM practice at their own home.
Who cannot join
- actively suicidal as per self-report (or score on CES-D) or on assessment by the physician
- they are currently participating in other similar studies
- currently practicing any type of formal meditation techniques regularly
- unable or unwilling to answer survey questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Breathing Exercises and Meditation on Health-Related Quality of Life in Dry Eye Disease Patients: A Pilot Study
People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision and is associated with depression and have an adverse impact on patient's quality of life. Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression, and anxiety, enhance quality of life in patients diagnosed with DED. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. The investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized to SKY followed by ASTM plus Usual care (UC) or UC 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. Along with HRQOL the investigators will measure changes in extent of depression and anxiety. Additionally, majority of current ophthalmic literature describes changes in clinical variables whilst lacking information on HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and routinely measured clinical data. Through this study the investigators shall attempt to correlate HRQOL with clinical data.
Read the detailed description
Background: Prevalence of dry eye disease (DED) ranges from 3.5% to 33.7% and increase with age. Further, DED is associated with decreased productivity, absenteeism from work, depression, and has an adverse impact on patient's quality of life. Odds of a DED patient suffering from depression is 2.9 and anxiety is 2.8. Yoga - a practice to help improve health and well-being - has also been the subject of clinical studies globally. Two central aspects of yoga practice are physical postures and breathing exercises. These breathing exercises aim to focus the mind, facilitate relaxation and enhance wellness.
Evidence further suggests beneficial effects of a standardized collection of breathing techniques called Sudarshan Kriya Yoga (SKY) on individuals suffering from depression. SKY includes three-stage breathing with Victory breath (slow deep breathing that consists of 4 to 6 breaths per minute), Bellow's breath (forceful rapid deep breathing that consists of 20 to 30 breaths per minute), and a rhythmic breath technique. SKY followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation. ASTM utilizes a specific sound value mantra to draw attention inward and permit the mind to experience a restful but alert state of consciousness. It helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. ASTM may help with depression, anxiety, stress, and may enhance quality of life. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. Key goal of proposed research is to evaluate HRQOL, depression, anxiety of patients with DED in SKY followed by ASTM and usual care (UC) versus UC alone from baseline to 24 weeks.
Primary Hypothesis: The investigators hypothesize that in patients with dry eye disease in SKY + ASTM + UC may lead to significant improvement in HRQoL compared to UC alone from baseline to 24 weeks.
Secondary Hypotheses: The investigators hypothesize that in patients with DED 1) HRQoL is associated with regularly measured clinical variables 2) SKY + ASTM + UC leads to significant improvement in depression and anxiety symptoms at 24 weeks compared to UC alone.
- Conditions
- Depression, Quality of Life, Dry Eye, Anxiety, Sleep
- Being tested
- SKY + ASTM + usual care, Usual care
- Medical subject headings
- Depression, Dry Eye Syndromes, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY + ASTM + usual careOther
Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation.
Usual careOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| SKY + ASTM + usual care | Experimental | Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) plus usual care Receives: Other: SKY + ASTM + usual care |
| Usual Care | Active comparator | Treatment as usual Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Related Quality of Life (HRQoL)
Health Related Quality of LIfe (HRQoL) is an essential measure of quality of life related to health. HRQoL will be measured using time trade-off (TTO) questionnaire. HRQoL varies between 0 and 1 where the score of 1 represents perfect health and 0 represents death.
Measured: Up to 24 weeks
Secondary outcomes (7)
Visual Function Score
Visual related quality of life measured using National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). The most widely used instrument in vision-related functioning is the NEI VFQ-25. It was designed specifically for a clinical setting and consists of 12 domains: general health, general vision, visual pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, colour vision and peripheral vision. The shorter 25-item version questionnaire is widely used in different groups of patients and shown to be internally consistent, reproducible and responsive in glaucoma patients. The NEI VFQ-25 scores have a closer relationship to clinical outcomes, in comparison to generic instruments. The scores range from 0 to 100 where higher score represents better vision related quality of life.
Measured: Up to 24 weeks
Depression
Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure depression. It is one of the most common validated tools used to measure depression in research to identify depressive symptoms. Additionally, it is a brief standardized valid tool for assessing depressive symptoms. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
Measured: Up to 24 weeks
State and Trait Anxiety
State-Trait Anxiety Inventory (STAI)
Measured: Up to 24 weeks
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Up to 24 weeks
Community Integration
The community integration questionnaire (CIQ) was used to provide a quantitative indicator for the level of social support and ability to perform appropriate roles at home and within the community. The CIQ contains 15-items and uses behavioural items of integration to achieve better reliability. The total CIQ score ranges from 0 to 29, with a higher score representing a higher level of social support and complete community integration.
Measured: Up to 24 weeks
Canadian Dry Eye Assessment
Canadian Dry Eye Assessment
Measured: Up to 24 weeks
Dry Eye Assessment
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jul 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monali Malvankar, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345381
- Sponsor's protocol ID
- 110762
- Status last verified
- Jun 2019
- First submitted
- 14 Nov 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD collected in this study will not be available to other researchers (e.g. outside the primary research group). Because the primary research group has the necessary expertise to conduct analysis and do not need any outside help.
Publications
Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
PubMed 9402817Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.
PubMed 19506195Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.
PubMed 12888056Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
PubMed 21045640Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12.
PubMed 27518547Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102.
PubMed 24626068Burns 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 Psychotherapy 25(2): 132-144, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breathing Exercises and Meditation on Health-Related Quality of Life in Dry Eye Disease Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03345381
- Acronym / sponsor ID
- 110762
- Conditions
- Depression, Quality of Life, Dry Eye, Anxiety, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision and is associated with depression and have an adverse impact on patient's quality of life. Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression, and anxiety, enhance quality of life in patients diagnosed with DED. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. The investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized to SKY followed by ASTM plus Usual care (UC) or UC 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. Along with HRQOL the investigators will measure changes in extent of depression and anxiety. Additionally, majority of current ophthalmic literature describes changes in clinical variables whilst lacking information on HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and routinely measured clinical data. Through this study the investigators shall attempt to correlate HRQOL with clinical data.
Detailed description
Background: Prevalence of dry eye disease (DED) ranges from 3.5% to 33.7% and increase with age. Further, DED is associated with decreased productivity, absenteeism from work, depression, and has an adverse impact on patient's quality of life. Odds of a DED patient suffering from depression is 2.9 and anxiety is 2.8. Yoga - a practice to help improve health and well-being - has also been the subject of clinical studies globally. Two central aspects of yoga practice are physical postures and breathing exercises. These breathing exercises aim to focus the mind, facilitate relaxation and enhance wellness.
Evidence further suggests beneficial effects of a standardized collection of breathing techniques called Sudarshan Kriya Yoga (SKY) on individuals suffering from depression. SKY includes three-stage breathing with Victory breath (slow deep breathing that consists of 4 to 6 breaths per minute), Bellow's breath (forceful rapid deep breathing that consists of 20 to 30 breaths per minute), and a rhythmic breath technique. SKY followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation. ASTM utilizes a specific sound value mantra to draw attention inward and permit the mind to experience a restful but alert state of consciousness. It helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. ASTM may help with depression, anxiety, stress, and may enhance quality of life. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. Key goal of proposed research is to evaluate HRQOL, depression, anxiety of patients with DED in SKY followed by ASTM and usual care (UC) versus UC alone from baseline to 24 weeks.
Primary Hypothesis: The investigators hypothesize that in patients with dry eye disease in SKY + ASTM + UC may lead to significant improvement in HRQoL compared to UC alone from baseline to 24 weeks.
Secondary Hypotheses: The investigators hypothesize that in patients with DED 1) HRQoL is associated with regularly measured clinical variables 2) SKY + ASTM + UC leads to significant improvement in depression and anxiety symptoms at 24 weeks compared to UC alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKY + ASTM + usual care | Experimental | Other: SKY + ASTM + usual careSudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) plus usual care |
| Usual Care | Active comparator | Other: Usual careTreatment as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- dry eye disease suspects or have mild to severe dry eye disease
- at least between 18 to 80 years of age
- 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 3 initial SKY and 4 initial ASTM training sessions
Key exclusion criteria (4 listed)
- actively suicidal as per self-report (or score on CES-D) or on assessment by the physician
- they are currently participating in other similar studies
- currently practicing any type of formal meditation techniques regularly
- unable or unwilling to answer survey questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKY + ASTM + usual careSudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation. | Other | SKY + ASTM + usual care |
| Usual careTreatment as usual | Other | Usual Care |
Primary outcome
Change in Health Related Quality of Life (HRQoL)
Time frame: Up to 24 weeks
Health Related Quality of LIfe (HRQoL) is an essential measure of quality of life related to health. HRQoL will be measured using time trade-off (TTO) questionnaire. HRQoL varies between 0 and 1 where the score of 1 represents perfect health and 0 represents death.
7 secondary outcomes
Visual Function Score
Time frame: Up to 24 weeks
Depression
Time frame: Up to 24 weeks
State and Trait Anxiety
Time frame: Up to 24 weeks
Sleep Quality
Time frame: Up to 24 weeks
Community Integration
Time frame: Up to 24 weeks
Canadian Dry Eye Assessment
Time frame: Up to 24 weeks
Dry Eye Assessment
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Background: PubMed 9402817Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
- Background: PubMed 19506195Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.
- Background: PubMed 12888056Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.
- Background: PubMed 21045640Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
- Background: PubMed 27518547Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12.
- Background: PubMed 24626068Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102.
- BackgroundBurns 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 Psychotherapy 25(2): 132-144, 2011.
- Individual participant dataSharing planned: No. De-identified IPD collected in this study will not be available to other researchers (e.g. outside the primary research group). Because the primary research group has the necessary expertise to conduct analysis and do not need any outside help.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monali Malvankar principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression and Quality of Life, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monali Malvankar (5196858500 ext. 61288, monali.malvankar@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Related Quality of Life (HRQoL) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345381, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.