Depression Clinical Trial
— ISHA-ImpactOfficial title:
Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study
Verified date | March 2024 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will include any participant who registered, and plans to attend the Inner Engineering In-Person Completion Course. In 2019, this course was offered in: Los Angeles in March, Philadelphia in April and Toronto & Dallas in November. This study has been involved in every IECO Course since 2019 and is still active today. Beginning in August 2021, investigators will recruit for the August Inner Engineering In-Person Completion Course. Investigators anticipate that this study can include up to 5,000 study participants. Participants would attend this course and complete the pre-modules regardless of whether or not they participate in this study.
Status | Active, not recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants who have registered to take the Inner Engineer Online Course. - Participants who have registered to take the Inner Engineer Completion Course. - Participants must be able to read and understand English. Exclusion Criteria: - Participants who report living outside the United States at the time of enrollment. - Participants < 18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Centre | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
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Selvaraj, N., et al., Heart Rate Dynamics during Shambhavi Mahamudra - A Practice of Isha Yoga. Journal of Complementary and Inegrative Medicine, 2008. 5(1): p. 1-22.
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Habits of daily living | The investigators use a validated scale for this purpose named, NHANES III. The scale measures the habits of daily living of an individual. This is a qualitative scale, and scoring is not done. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Nictoine Consumption | The investigators use several validated scale for this purpose namely, NHANES III, Nicotine dependence, Negative Health Expectancies and Emotional Expectancies among others. The scales measure the nicotine dependence and aids in quantifying dependence which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. Higher scores suggest greater nicotine dependence. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Alcohol Consumption | The investigators use a validated scale for this purpose namely, AUDIT. The scale measures the individual's dependence on alcohol and objectively quantifies dependence which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. A score of 8 or more is considered to be hazardous use of alcohol. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Pain Intensity | The investigators use a validated scale for this purpose namely, Pain intensity & Pain interference scales. The scales measure the individuals' pain perception, and quantify the effects of the individuals' pain which in turn aids in evaluating any change on the individual's perception after the Inner Engineering intervention. higher scores suggestive of increased pain perception. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Sleep patterns & behavior | The investigators use a validated scale for this purpose namely, Pittsburgh Sleep Quality Index (PSQI). The scale measure the individuals' sleep patterns & behavior and quantifies sleep quality which in turn aids in evaluating any change on the individual's sleep quality after the Inner Engineering intervention. Scores higher than 5 are suggestive of poor sleep quality. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Mindfulness | The investigators use a validated scale for this purpose namely, Mindfulness Attention Awareness Scale (MAAS). The scale measures the individuals' ability for receptive awareness and attention to present. This aids in evaluating any change on the individual's awareness levels after the Inner Engineering intervention. Higher scores are suggestive of increased mindfulness and awareness. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Emotional health | The investigators use a validated scale for this purpose namely, PERMA profiler. The scale measures the 5 pillars of well-being (Positive emotions, engagement, relationship, meaning, accomplishment) along with negative emotions and health in the individual. Higher scores are suggestive of better outcomes. This aids in evaluating any change on the individual's awareness levels after the Inner Engineering intervention. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Anxiety | The investigators used the PROMIS (Anxiety-8) an 8-item validated instrument that assesses the severity of anxiety. Participants are asked on a scale of 1 (Never) to 5 (Always) on the frequency of occurrence of each negative experience. Overall score is computed based on sum from individual responses. A higher sum indicates greater anxiety. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Other | Depression | The investigators used the CES-D 20-item scale to assess depression. Each item is coded 1 "rarely or none of the time (less than 1 day)" to 4 "most or all of the time (5-7 days)." Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Primary | Changes in Perceived Stress Levels | The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering has over them in long term. The investigators use a validated scale for this purpose named, Perceived Stress Scale (PSS). The scale measures the degree to which situations in participant's life are appraised as stressful. This is defined to be the key secondary outcome for the study. Higher scores are suggestive of more stress. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. | |
Primary | Mood Changes | The study aims to evaluate changes in mood profiles affected by the Inner Engineering Online (IEO) over time. For evaluation of mood profiles the investigators use a validated scale named, Profile of Mood States (POMS). The scale measures different dimensions of mood swings over a period of time and calculates Total Mood Disturbances by performing a sub-scale analysis. The subscales defined include Tension, Depression, Anger, Fatigue, Confusion & Vigor. Higher scores are suggestive of poorer outcome. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame. | The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months. |
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