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Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program

Inner Engineering Online (IEO) Intervention for a Specific Company Employee Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04126564
Enrollment
71
Registered
2019-10-15
Start date
2019-08-30
Completion date
2020-06-07
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout, Depression, Anxiety, Stress

Keywords

Burnout, Stress, Anxiety, Depression, Meditation, Inner Engineering Online

Brief summary

In this randomized controlled trial; differences in overall stress, burnout and wellbeing will be assessed for employees of a company participating in Inner Engineering Online, an online mind-body course that incorporates both meditation and yoga. The study will be conducted in two phases, where in participants will be advised to practice meditation or read books.

Detailed description

The benign behavioral intervention involved is Inner Engineering Online (IEO), a mind-body course that incorporates meditation and yoga, as well as reading a book or journal of their choice.The subjects will be randomized into two groups after they agree to the participate in the study. The study will be conducted in 2 phases. Phase 1: If they are in group 1, they will participate in IEO which includes practice of meditation & yoga daily for a minimum of 30 minutes and complete a IEO activity log for 30 days.They will be asked to complete a set of questionnaires at baseline and after 30 days.If they are in group 2, they are asked to read a book or journal of their choice for 30 minutes each day for the first 30 days and complete a reading log. Phase 2: After they complete reading for 30 days, group 2 participants will now participate in IEO which includes practice of meditation & yoga daily for a minimum of 30 minutes and complete an IEO activity log for the next 30 days. They are asked to complete a set of questionnaires at baseline, 30 days, and at 60 days. These questionnaires aim to assess for burnout, stress, and well-being. These include: * Maslach Burnout Inventory - Human Services Survey - 16 item questionnaire measuring burnout * Perceived Stress Scale - 10 item questionnaire measuring stress * Center for Epidemiology Studies depression Scale (CES-D) - 20 item questionnaire measuring depression * Emotional Distress and Anxiety Short Form - 7 item questionnaire measuring anxiety * Joy subscale of the Dispositional Positive Emotion Scale - 6 item questionnaire measuring happiness * Mindful Attention Awareness Scale - 15 item questionnaire measuring mindfulness Finally, participants of both the groups will be subjected to a 30 day follow-up surveys after a month of IEO completion. They will receive a set of previously administered questionnaire and a compliance survey at this point. Group 1 participants receive this survey at the 60 day time point while Group 2 participants receive it at 90 days.

Interventions

BEHAVIORALInner 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.

BEHAVIORALReading 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.

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

A cross over model ensures that both experimental and control group participants get to experience the effects of a proposed intervention. For our study, we are providing Inner Engineering Online as an intervention and both experimental and control group participants get to experience the benefits of meditation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age\>=18 years 2. Interest in Inner Engineering Online Program

Exclusion criteria

1. Low English Proficiency 2. Not currently residing in United States

Design outcomes

Primary

MeasureTime frameDescription
Maslach Burnout Inventory Scale General SurveyFor Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksThe 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.

Secondary

MeasureTime frameDescription
Perceived Stress Score LevelsFor Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksThe 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.

Other

MeasureTime frameDescription
Mindfulness LevelFor Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksWe 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.
Dispositional Positive Emotions Scale (DPES- Joy Subscale)For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksWe 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.
Centre for Epidemiologic Studies, Depression ScaleFor Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksWe 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.
Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeksWe 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

The 71 participants were subjected to baseline survey data collection following which they were randomized to their individual study groups.

Participants by arm

ArmCount
IEO Intervention Group
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.
35
Control Group
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.
36
Total71

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyWithdrawal by Subject02

Baseline characteristics

CharacteristicControl GroupTotalIEO Intervention Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
34 Participants65 Participants31 Participants
Age, Continuous38.7 years
STANDARD_DEVIATION 10.19
39.38 years
STANDARD_DEVIATION 10.2
40.5 years
STANDARD_DEVIATION 10.23
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
34 Participants65 Participants31 Participants
Sex: Female, Male
Female
16 Participants33 Participants17 Participants
Sex: Female, Male
Male
18 Participants32 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Maslach Burnout Inventory Scale General Survey

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEDIAN)
IEO Intervention GroupMaslach Burnout Inventory Scale General Survey4 weeks47 score on a scale
IEO Intervention GroupMaslach Burnout Inventory Scale General SurveyBaseline52 score on a scale
Control Then IEO Intervention GroupMaslach Burnout Inventory Scale General Survey4 weeks47.5 score on a scale
Control Then IEO Intervention GroupMaslach Burnout Inventory Scale General Survey8 weeks (only for Control then IEO Intervention Group)49.5 score on a scale
Control Then IEO Intervention GroupMaslach Burnout Inventory Scale General SurveyBaseline52 score on a scale
Secondary

Perceived Stress Score Levels

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
IEO Intervention GroupPerceived Stress Score LevelsBaseline16.9 score on a scaleStandard Deviation 6.33
IEO Intervention GroupPerceived Stress Score Levels4 weeks13.1 score on a scaleStandard Deviation 5.96
Control Then IEO Intervention GroupPerceived Stress Score LevelsBaseline16.2 score on a scaleStandard Deviation 5.65
Control Then IEO Intervention GroupPerceived Stress Score Levels4 weeks14.9 score on a scaleStandard Deviation 5.33
Control Then IEO Intervention GroupPerceived Stress Score LevelsWeek 8 (only for Control Group then IEO Intervention group)13.2 score on a scaleStandard Deviation 6.81
Other Pre-specified

Centre for Epidemiologic Studies, Depression Scale

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
IEO Intervention GroupCentre for Epidemiologic Studies, Depression ScaleBaseline40.0 score on a scaleStandard Deviation 9.07
IEO Intervention GroupCentre for Epidemiologic Studies, Depression ScaleWeek 437.2 score on a scaleStandard Deviation 6.47
Control Then IEO Intervention GroupCentre for Epidemiologic Studies, Depression ScaleBaseline40.1 score on a scaleStandard Deviation 7.6
Control Then IEO Intervention GroupCentre for Epidemiologic Studies, Depression ScaleWeek 438.0 score on a scaleStandard Deviation 5.97
Control Then IEO Intervention GroupCentre for Epidemiologic Studies, Depression ScaleWeek 8 (only for Control Group then IEO Intervention group)37.9 score on a scaleStandard Deviation 5.75
Other Pre-specified

Dispositional Positive Emotions Scale (DPES- Joy Subscale)

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
IEO Intervention GroupDispositional Positive Emotions Scale (DPES- Joy Subscale)Baseline4.22 score on a scaleStandard Deviation 1.43
IEO Intervention GroupDispositional Positive Emotions Scale (DPES- Joy Subscale)Week 44.56 score on a scaleStandard Deviation 1.56
Control Then IEO Intervention GroupDispositional Positive Emotions Scale (DPES- Joy Subscale)Baseline4.61 score on a scaleStandard Deviation 1.19
Control Then IEO Intervention GroupDispositional Positive Emotions Scale (DPES- Joy Subscale)Week 44.64 score on a scaleStandard Deviation 1.23
Control Then IEO Intervention GroupDispositional Positive Emotions Scale (DPES- Joy Subscale)Week 8 (only for Control Group then IEO Intervention group)4.78 score on a scaleStandard Deviation 1.36
Other Pre-specified

Mindfulness Level

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
IEO Intervention GroupMindfulness LevelBaseline4.23 score on a scaleStandard Deviation 0.92
IEO Intervention GroupMindfulness LevelWeek 44.64 score on a scaleStandard Deviation 0.77
Control Then IEO Intervention GroupMindfulness LevelBaseline4.19 score on a scaleStandard Deviation 0.98
Control Then IEO Intervention GroupMindfulness LevelWeek 44.44 score on a scaleStandard Deviation 0.81
Control Then IEO Intervention GroupMindfulness LevelWeek 8 (only for Control Group then IEO Intervention group)4.60 score on a scaleStandard Deviation 0.79
Other Pre-specified

Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.

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.

Time frame: For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 8 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
IEO Intervention GroupPatient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.Baseline16.4 score on a scaleStandard Deviation 5.19
IEO Intervention GroupPatient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.Week 413.0 score on a scaleStandard Deviation 5.62
Control Then IEO Intervention GroupPatient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.Baseline16.3 score on a scaleStandard Deviation 4.69
Control Then IEO Intervention GroupPatient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale.Week 414.6 score on a scaleStandard Deviation 5.58
Control Then IEO Intervention GroupPatient-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 scaleStandard Deviation 5.37

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026