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Completed

NCT Number: NCT04126564

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>=18 years
  • Interest in Inner Engineering Online Program

Exclusion criteria

  • Low English Proficiency
  • Not currently residing in United States

Treatment and study plan

Inner Engineering Online

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Maslach Burnout Inventory Scale General Survey

    Time frame: 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 outcomes

  1. Perceived Stress Score Levels

    Time frame: 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 outcomes

  1. Mindfulness Level

    Time frame: 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.

  2. Dispositional Positive Emotions Scale (DPES- Joy Subscale)

    Time frame: 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.

  3. Centre for Epidemiologic Studies, Depression Scale

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2019
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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