Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items) |
A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Mindfulness of Activities |
A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Mindfulness of Feelings / Emotions |
A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Loneliness |
A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Connection With Others |
A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Decentering |
A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Insight |
A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Purpose |
A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Stressor Exposure |
A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Personal Values / Meaning |
A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Rumination |
A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in EMA-assessed Informal Practice |
A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
4 times per day from baseline to post-test (week 4) |
|
Other |
Change in Pre- and Post-practice Positive Affect |
Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. |
Before and after meditation practices between baseline and post-test (week 4) |
|
Other |
Change in Pre- and Post-practice Negative Affect |
Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much |
Before and after meditation practices between baseline and post-test (week 4) |
|
Other |
Change in Post-practice Focus |
A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time |
Before and after meditation practices between baseline and post-test (week 4) |
|
Other |
Digital Working Alliance Inventory (DWAI) |
The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance. |
Post-test (week 4) |
|
Primary |
Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App |
Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app |
Baseline to post-test (week 4) |
|
Primary |
Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days |
Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app. |
Baseline to post-test (week 4) |
|
Primary |
Percentage of EMA Completed |
Percentage of EMA assessments that were completed |
Baseline to post-test (week 4) |
|
Primary |
Study Completion Rate |
Percentage of participants completing pre- and post-test measures |
Baseline to post-test (week 4) |
|
Primary |
Number of Participants Completing Practices =50% of Days |
Number of participants completing practices =50% of days |
Baseline to post-test (week 4) |
|
Primary |
Modified System Usability Scale (MSUS) |
The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability. |
Post-test (week 4) |
|
Primary |
Change in Attitudes Towards Psychological Online Interventions (ATPOI) |
The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions. |
Baseline, and post-test (week 4) |
|
Primary |
HMP App Utilization: Minutes |
Minutes of meditation practice completed |
Baseline to post-test (week 4) |
|
Primary |
HMP App Utilization: Days |
Number of days the app was accessed. |
Baseline to post-test (week 4) |
|
Primary |
HMP App Utilization: Number of Activities |
|
Baseline to post-test (week 4) |
|
Secondary |
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety |
Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Healthy Minds Index (HM Index): Awareness |
The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Healthy Minds Index (HM Index): Connection |
The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Healthy Minds Index (HM Index): Insight |
The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Healthy Minds Index (HM Index): Purpose |
The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Wellbeing Growth Mindset |
Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable). |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale |
FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in NIH Toolbox Loneliness |
NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Experiences Questionnaire (EQ) Decentering Subscale |
Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale |
MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life. |
Baseline, and post-test (week 4) |
|
Secondary |
Change in PROMIS Sleep Disturbance |
Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance. |
Baseline, and post-test (week 4) |
|
Secondary |
Count of Participant Responses to Adverse Event Relevant Survey Item |
Participants were asked a single survey item to assess their meditation experience. The query was "I had challenging, difficult, or distressing experiences as a result of my meditation during this study." Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here. |
up to 4 weeks |
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