Burnout, Depression, Anxiety, Stress
Conditions
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
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 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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Maslach Burnout Inventory Scale General Survey | For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Score Levels | For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness Level | For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 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. |
| Dispositional Positive Emotions Scale (DPES- Joy Subscale) | For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 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. |
| Centre for Epidemiologic Studies, Depression Scale | For Phase 1 analysis:Baseline to 4 weeks. For Phase 2 analysis: Baseline to 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. |
| 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 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Control Group | Total | IEO Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 65 Participants | 31 Participants |
| Age, Continuous | 38.7 years STANDARD_DEVIATION 10.19 | 39.38 years STANDARD_DEVIATION 10.2 | 40.5 years STANDARD_DEVIATION 10.23 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 34 Participants | 65 Participants | 31 Participants |
| Sex: Female, Male Female | 16 Participants | 33 Participants | 17 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IEO Intervention Group | Maslach Burnout Inventory Scale General Survey | 4 weeks | 47 score on a scale |
| IEO Intervention Group | Maslach Burnout Inventory Scale General Survey | Baseline | 52 score on a scale |
| Control Then IEO Intervention Group | Maslach Burnout Inventory Scale General Survey | 4 weeks | 47.5 score on a scale |
| Control Then IEO Intervention Group | Maslach Burnout Inventory Scale General Survey | 8 weeks (only for Control then IEO Intervention Group) | 49.5 score on a scale |
| Control Then IEO Intervention Group | Maslach Burnout Inventory Scale General Survey | Baseline | 52 score on a scale |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IEO Intervention Group | Perceived Stress Score Levels | Baseline | 16.9 score on a scale | Standard Deviation 6.33 |
| IEO Intervention Group | Perceived Stress Score Levels | 4 weeks | 13.1 score on a scale | Standard Deviation 5.96 |
| Control Then IEO Intervention Group | Perceived Stress Score Levels | Baseline | 16.2 score on a scale | Standard Deviation 5.65 |
| Control Then IEO Intervention Group | Perceived Stress Score Levels | 4 weeks | 14.9 score on a scale | Standard Deviation 5.33 |
| Control Then IEO Intervention Group | Perceived Stress Score Levels | Week 8 (only for Control Group then IEO Intervention group) | 13.2 score on a scale | Standard Deviation 6.81 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IEO Intervention Group | Centre for Epidemiologic Studies, Depression Scale | Baseline | 40.0 score on a scale | Standard Deviation 9.07 |
| IEO Intervention Group | Centre for Epidemiologic Studies, Depression Scale | Week 4 | 37.2 score on a scale | Standard Deviation 6.47 |
| Control Then IEO Intervention Group | Centre for Epidemiologic Studies, Depression Scale | Baseline | 40.1 score on a scale | Standard Deviation 7.6 |
| Control Then IEO Intervention Group | Centre for Epidemiologic Studies, Depression Scale | Week 4 | 38.0 score on a scale | Standard Deviation 5.97 |
| Control Then IEO Intervention Group | 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 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IEO Intervention Group | Dispositional Positive Emotions Scale (DPES- Joy Subscale) | Baseline | 4.22 score on a scale | Standard Deviation 1.43 |
| IEO Intervention Group | Dispositional Positive Emotions Scale (DPES- Joy Subscale) | Week 4 | 4.56 score on a scale | Standard Deviation 1.56 |
| Control Then IEO Intervention Group | Dispositional Positive Emotions Scale (DPES- Joy Subscale) | Baseline | 4.61 score on a scale | Standard Deviation 1.19 |
| Control Then IEO Intervention Group | Dispositional Positive Emotions Scale (DPES- Joy Subscale) | Week 4 | 4.64 score on a scale | Standard Deviation 1.23 |
| Control Then IEO Intervention Group | 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 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IEO Intervention Group | Mindfulness Level | Baseline | 4.23 score on a scale | Standard Deviation 0.92 |
| IEO Intervention Group | Mindfulness Level | Week 4 | 4.64 score on a scale | Standard Deviation 0.77 |
| Control Then IEO Intervention Group | Mindfulness Level | Baseline | 4.19 score on a scale | Standard Deviation 0.98 |
| Control Then IEO Intervention Group | Mindfulness Level | Week 4 | 4.44 score on a scale | Standard Deviation 0.81 |
| Control Then IEO Intervention Group | Mindfulness Level | Week 8 (only for Control Group then IEO Intervention group) | 4.60 score on a scale | Standard Deviation 0.79 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IEO Intervention Group | Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale. | Baseline | 16.4 score on a scale | Standard Deviation 5.19 |
| IEO Intervention Group | Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale. | Week 4 | 13.0 score on a scale | Standard Deviation 5.62 |
| Control Then IEO Intervention Group | Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale. | Baseline | 16.3 score on a scale | Standard Deviation 4.69 |
| Control Then IEO Intervention Group | Patient-Reported Outcomes Measurement Information System Emotional Distress- Anxiety Short Form Scale. | Week 4 | 14.6 score on a scale | Standard Deviation 5.58 |
| Control Then IEO Intervention Group | 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 |