Trial Outcomes & Findings for Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program (NCT NCT04126564)
NCT ID: NCT04126564
Last Updated: 2024-09-23
Results Overview
The study aims to evaluate changes in burnout levels affected by intervention using the Maslach Burnout Inventory scale General Survey (MBI\_GS). This survey consists of 16 questions and designed for use with occupational groups other than human services and education, including those working in jobs such as customer service, maintenance, manufacturing, management, and most other professions.Sum of 16 items is reported for each study period. With possible range of total score between 0-80, a higher score indicates more burnout or worse score addressing their experience of burnout.
COMPLETED
NA
71 participants
For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks
2024-09-23
Participant Flow
Participant were recruited from an IT firm named S2Tech. An awareness drive was conducted throughout the organization to enable participant recruitment for a period of 1 month. 82 participants were screened, 6 of whom did not meet inclusion criteria \& 5 met with the exclusion criteria. All 71 participants were enrolled into the study since Aug 30 2019.
The 71 participants were subjected to baseline survey data collection following which they were randomized to their individual study groups.
Participant milestones
| Measure |
IEO Intervention Group
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Group Then IEO Intervention
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
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|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
Study Phase I (30 Days)
|
35
|
35
|
|
Overall Study
Study Phase II (30 Days)
|
35
|
34
|
|
Overall Study
Follow Up for Control Group Then IEO Intervention Group Only (30 Days)
|
0
|
33
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
IEO Intervention Group
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Group Then IEO Intervention
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
Baseline characteristics by cohort
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Phase I: Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Phase I: Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
Phase II: Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Total
n=71 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
0 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
0 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
34 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
65 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
0 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
0 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 10.23 • n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
38.7 years
STANDARD_DEVIATION 10.19 • n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
39.38 years
STANDARD_DEVIATION 10.20 • n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their age. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their age.
|
|
Sex: Female, Male
Female
|
17 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
16 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
33 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
|
Sex: Female, Male
Male
|
14 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
18 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
32 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their sex. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their sex.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
31 Participants
n=31 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their Region. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their Region.
|
34 Participants
n=34 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their Region. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their Region.
|
65 Participants
n=65 Participants • Of 34 participants in the Intervention arm, only 31 participants responded to the question regarding their Region. Of 37 participants in the Control arm, only 34 participants responded to the question regarding their Region.
|
PRIMARY outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, only 34 participants responded to the question regarding their Baseline Maslach Burnout Inventory score. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks.
The study aims to evaluate changes in burnout levels affected by intervention using the Maslach Burnout Inventory scale General Survey (MBI\_GS). This survey consists of 16 questions and designed for use with occupational groups other than human services and education, including those working in jobs such as customer service, maintenance, manufacturing, management, and most other professions.Sum of 16 items is reported for each study period. With possible range of total score between 0-80, a higher score indicates more burnout or worse score addressing their experience of burnout.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
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|---|---|---|
|
Maslach Burnout Inventory Scale General Survey
Baseline
|
52 score on a scale
Interval 44.0 to 64.0
|
52 score on a scale
Interval 46.0 to 63.0
|
|
Maslach Burnout Inventory Scale General Survey
4 weeks
|
47 score on a scale
Interval 37.2 to 57.2
|
47.5 score on a scale
Interval 44.0 to 56.0
|
|
Maslach Burnout Inventory Scale General Survey
8 weeks (only for Control then IEO Intervention Group)
|
—
|
49.5 score on a scale
Interval 42.0 to 52.8
|
SECONDARY outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, 34 participants responded to the question regarding their PSS score. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks.
The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering Online has over them. We 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 the key secondary outcome for our study. We assess for change in perceived stress levels by analyzing the PSS score for each participant and comparing it to pre \& post intervention results. PSS is a 10 question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements. Items from each of the 10 questions are then summed to create a total perceived stress score, ranging of 0 to 40. The lower score indicates less stress, higher score indicates high perceived stress.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
|
|---|---|---|
|
Perceived Stress Score Levels
Baseline
|
16.9 score on a scale
Standard Deviation 6.33
|
16.2 score on a scale
Standard Deviation 5.65
|
|
Perceived Stress Score Levels
4 weeks
|
13.1 score on a scale
Standard Deviation 5.96
|
14.9 score on a scale
Standard Deviation 5.33
|
|
Perceived Stress Score Levels
Week 8 (only for Control Group then IEO Intervention group)
|
—
|
13.2 score on a scale
Standard Deviation 6.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, only 34 participants responded to the question regarding their Baseline Maslach Burnout Inventory score. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks.
We assess for change in Mindfulness levels by using 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. We compute the MAAS scores for each participant which is a mean score for 15 item questionnaires and compare the pre \& post intervention results to look for change. Participants are asked to rate on a scale of 1 (Almost Always) to 6 (Almost Never) to assess the frequency of occurrence of each experience. Mean is then computed using items from each of the 15 questions to create a MAAS score, ranging from 0 to 6. Higher MAAS scores indicate better mindfulness state.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
|
|---|---|---|
|
Mindfulness Level
Baseline
|
4.23 score on a scale
Standard Deviation 0.92
|
4.19 score on a scale
Standard Deviation 0.98
|
|
Mindfulness Level
Week 4
|
4.64 score on a scale
Standard Deviation 0.77
|
4.44 score on a scale
Standard Deviation 0.81
|
|
Mindfulness Level
Week 8 (only for Control Group then IEO Intervention group)
|
—
|
4.60 score on a scale
Standard Deviation 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, 34 participants responded to the question regarding their Baseline DPES- Joy subscale. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks.
We assess for change in the individuals' ability to feel joy and look for it in the mundane by using a validated scale for this purpose namely, Dispositional Positive Emotions Scale (DPES) particularly the Joy subscale. The Sub-scale measures the individuals' dispositional ability to feel joy in life. The aids in evaluating any change on the individual's joy predisposition levels after the Inner engineering intervention. We compute the DPES-JOY subscale scores for each participant which is a mean score for 6 item questionnaires and compare the pre \& post intervention results to look for change. DPES-JOY scale ranges from 0 to 6 and higher DPES-JOY scale indicates higher joy in life.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
|
|---|---|---|
|
Dispositional Positive Emotions Scale (DPES- Joy Subscale)
Baseline
|
4.22 score on a scale
Standard Deviation 1.43
|
4.61 score on a scale
Standard Deviation 1.19
|
|
Dispositional Positive Emotions Scale (DPES- Joy Subscale)
Week 4
|
4.56 score on a scale
Standard Deviation 1.56
|
4.64 score on a scale
Standard Deviation 1.23
|
|
Dispositional Positive Emotions Scale (DPES- Joy Subscale)
Week 8 (only for Control Group then IEO Intervention group)
|
—
|
4.78 score on a scale
Standard Deviation 1.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, only 34 participants responded to the question regarding their CES-D scores. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks.
We assess for change in the individual feeling depressed using a validated scale for this purpose namely, Centre for Epidemiologic Studies, Depression scale (CES-D). The scale comprises of 20 item questionnaires which measures the major facets of depression based on self-reported symptomatology. We compute the CES-D scale scores for each participant and compare the pre \& post intervention results to look for change. Possible range of scores is 0-60 with higher scores indicating the presence of more symptomatology.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
|
|---|---|---|
|
Centre for Epidemiologic Studies, Depression Scale
Baseline
|
40.0 score on a scale
Standard Deviation 9.07
|
40.1 score on a scale
Standard Deviation 7.60
|
|
Centre for Epidemiologic Studies, Depression Scale
Week 4
|
37.2 score on a scale
Standard Deviation 6.47
|
38.0 score on a scale
Standard Deviation 5.97
|
|
Centre for Epidemiologic Studies, Depression Scale
Week 8 (only for Control Group then IEO Intervention group)
|
—
|
37.9 score on a scale
Standard Deviation 5.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksPopulation: Of 35 participants in the Intervention arm, only 34 participants responded to the question regarding their Baseline PROMIS score. Of 36 participants in the Control arm, 1 participant withdrew from the study between 4 weeks and 8 weeks. Of 36 participants in the Control arm, 1 participant withdrew from the study between baseline to 4 weeks, and 1 participant withdrew from the study between 4 weeks and 8 weeks.
We assess for change in the individual feeling anxious using a validated scale for this purpose namely, Patient-Reported Outcomes Measurement Information System (PROMIS) emotional distress- Anxiety short form scale. The scale comprises of 7 item questionnaires which measures the major facets of anxiety based on self-reported symptomatology. Sum is computed for the responses and scores range between 7-35, where higher scores indicating greater/wrose severity of anxiety. We compute the PROMIS Anxiety short form scale scores for each participant and compare the pre \& post intervention results to look for change.
Outcome measures
| Measure |
IEO Intervention Group
n=35 Participants
The Group 1 is the active study group which receives the online mindfulness intervention first.
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
|
Control Then IEO Intervention Group
n=36 Participants
Group 2 will be asked to read a book or journal of their choice for first 30 days, and then recieve online mindfulness intervention (IEO).
Inner Engineering Online: Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations \& yoga.
Reading a book/ journal: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.
Baseline
|
16.4 score on a scale
Standard Deviation 5.19
|
16.3 score on a scale
Standard Deviation 4.69
|
|
Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.
Week 4
|
13.0 score on a scale
Standard Deviation 5.62
|
14.6 score on a scale
Standard Deviation 5.58
|
|
Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.
Week 8 (only for Control Group then IEO Intervention group)
|
—
|
13.0 score on a scale
Standard Deviation 5.37
|
Adverse Events
IEO Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Balachundar Subramaniam
Sadhguru Center for a Conscious Planet, BIDMC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place