Depression, Anxiety
Conditions
Keywords
HMP app, healthy minds program, Microsupport, meditation
Brief summary
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Detailed description
Participants will be randomly assigned to various support conditions that vary across three binary factors, 1. Coaching session vs no coaching 2. On-demand email support (Yes/No) 3. Microsupport messages (Yes/No) Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out. Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
Interventions
OTHERIntroductory Coaching Session
Participant is randomized to receive a 30-minute meditation coaching session
OTHERIntroductory Information Session
Participant is randomized to receive a 30-minute information session
OTHEROn-Demand Email Support
email support throughout the 4 week intervention period
OTHERMicrosupport
Text message microsupport throughout the 4 week intervention period
Sponsors
University of Wisconsin, Madison
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10) * Proficiency in English * Access to a smartphone and internet * Ability to receive text messages
Exclusion criteria
* Non-US citizen or legal resident (green card holder) * History of psychosis or mania * Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9 * Individuals who do not provide the information required for GUID generation * Previous participation * Individuals who do not have their camera turned on and remain visible on camera during the virtual introductory and coaching sessions (if applicable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The PHQ-ADS is scored by summing responses to its 16 items (combining the PHQ-9 and GAD-7), with scores ranging from 0 to 48, where higher scores indicate greater distress. Each item uses a 0-3 scale (0=Not at all, 3=Nearly every day). Common interpretation is 10 (mild), 20 (moderate), and 30 (severe) distress. |
| Anxiety Measured from Evening Daily Diary Items | Daily through the Intervention Period (up to 4 weeks) | Evening daily diary will include a single-item measure of anxiety using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe anxiety. Daily means with and standard deviations will be reported. |
| Depression Measured from Evening Daily Diary Items | Daily through the Intervention Period (up to 4 weeks) | Evening daily diary will include a single-item measures of depression using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe depression. Daily means with and standard deviations will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression | baseline, week 1, week 2, week 3, week 4, 6-month follow up | A computer-adaptive measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression. It provides t-scores with a mean of 50 and SD of 10 |
| PROMIS Toolbox Meaning and Purpose Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life. |
| NIH Toolbox Loneliness Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness. |
| Beck's Depression Inventory (BDI) Item 9 Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | Item 9 on the Beck Depression Inventory (BDI) assesses suicidal thoughts or wishes. The possible scores for this item are 0, 1, 2, or 3, corresponding to different levels of severity. A score of 0 indicates no suicidal thoughts, while higher scores indicate increasing severity of suicidal ideation. |
| Five Facet Mindfulness Questionnaire (Awareness subscale) Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is an 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus. |
| Experiences Questionnaire Decentering subscale Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience. |
| Healthy Minds Index (HM Index) - Awareness Score | baseline, week 4, 6-month follow up | The HM Index is a 17-item questionnaire assessing 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. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness. |
| Healthy Minds Index (HM Index) - Connection Score | baseline, week 4, 6-month follow up | The HM Index is a 17-item questionnaire assessing 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. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection. |
| Healthy Minds Index (HM Index) - Insight Score | baseline, week 4, 6-month follow up | The HM Index is a 17-item questionnaire assessing 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. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight. |
| Healthy Minds Index (HM Index) - Purpose Score | baseline, week 4, 6-month follow up | The HM Index is a 17-item questionnaire assessing 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. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose. |
| Growth Mindset Scale Adapted for Well-being Score | baseline, week 4, 6-month follow up | The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 is "strongly disagree" to 6 being "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset. |
| Digital Working Alliance Inventory (DWAI) Score | week 1, week 2, week 3, week 4 | DWAI is a six-item questionnaire designed to assess the working alliance within the Healthy Minds Program (HMP) app. It measures the user's connection and agreement with the app, focusing on the bond, tasks, and goals of the therapeutic relationship. It is scored on a 7-point Likert scale, with scores ranging from 6-42. Higher scores indicate a stronger working alliance with the HMP app. |
| Morning Daily Diary Items | Daily through the Intervention Period (up to 4 weeks) | Morning daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, stress, busyness, rumination (2 items), sleep quality, motivation to practice meditation, and expectations and challenges related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, greater happiness, more severe depression or anxiety, better sleep quality, or greater motivation and perceived helpfulness or frustration with HMP use that morning. Daily means with and standard deviations will be reported. |
| Evening Daily Diary Items | Daily through the Intervention Period (up to 4 weeks) | Evening daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, happy event, stress exposure, rumination (2 items), and expectations related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, more severe depression or anxiety, happy event and stressor exposure experience, or greater motivation and perceived helpfulness with HMP use that day. Daily means with and standard deviations will be reported. |
| Percentage of participants with a formal practice | Daily through the Intervention Period (up to 4 weeks) | Participants' engagement in formal mindfulness practice will be assessed twice a day with a binary yes/no response. Formal practice is defined as using the HMP app. |
| Percentage of participants with an informal practice | Daily through the Intervention Period (up to 4 weeks) | Participants' engagement in informal mindfulness practice will be assessed twice a day with a 5-point Likert scale (1 = not at all, 5 = all day long). Informal practice is defined as applying well-being practices in daily life. |
| Percentage of participants who received a text message and applied a well-being strategy | Daily through the Intervention Period (up to 4 weeks) | Participants will indicate whether they received a text message from the study that day (yes/no). If they respond "yes," they will then report whether the message encouraged them to apply a wellbeing strategy (yes/no) and rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much). |
| Extent to which participants applied a well-being strategy in their day-to-day activities | Daily through the Intervention Period (up to 4 weeks) | Participants who received a text message and applied a well-being strategy will be asked to rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much). |
| Change in PROMIS Anxiety Score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The PROMIS Anxiety Score is a computer adaptive measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5-point Likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. It provides t-scores with a mean of 50 and SD of 10. Higher t-scores indicate higher levels of anxiety. |
| Medication and Therapy Questionnaire | baseline, week 4, 6-month follow up | The 3-item Medication and Therapy Questionnaire collects information on whether participants received medication or therapy for mental health concerns in the past month. Each item is a yes/no question. |
| Change in WHODAS 2.0 | baseline, week 4, 6-month follow up | WHODAS 2.0 is a 12-item measure which evaluates healthy-related disability in the past 30 days across 6 domains (cognition, mobility, self-care, getting along, life activities, and participation). It is scored on a 5-point Likert scale were 0 = None and 4 = Extreme or cannot do. The total score ranges from 0 to 48 with higher scores indicating higher level of impairment. |
| Change in the Positive & Negative Affect Schedule (PANAS-SF) | baseline, week 4, 6-month follow up | PANAS is a 10-item measure assessing positive (5 items) and negative (5 items) emotions using a 5-point Likert scale, in which 1 = Never and 5 = Always. The total score of each scale ranges from 5-25. Positive Affect score means higher levels of enthusiastic, alert, and pleasurable engagement. A higher Negative Affect score indicates higher level of distress, nervousness, or anger. |
| Change in Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) | baseline, week 4, 6-month follow up | AUDIT-C is a 3-item brief alcohol screen using a 5-point Likert scale. The possible range of score is 0-12. Higher scores suggest more hazardous alcohol use or active alcohol use disorders. |
| HMP Engagement Measure | week 4, 6-month follow up | HMP engagement is a 16-item measure which assess participant's usage experience with the Healthy Minds Program. It is scored on a 5-point Likert scale where 1 = Strongly disagree to 5 = Strongly agree. The total possible range of scores is 0-80 where higher scores indicate more positive engagement with the app. |
| Change in Adapted Client Service Receipt Inventory (CSRI) | baseline, 6-month follow up | The adapted CSRI includes five items assessing the number of primary care visits, mental health outpatient visits, emergency or urgent care visits, hospital nights, and mental health or sleep medications used during a 12-week recall period. Responses are recorded as numeric counts ranging from zero to no fixed upper limit, with higher values indicating greater healthcare service use and higher associated healthcare costs. |
| Change in Work Productivity and Activity Impairment (WPA) | baseline, week 4, 6-month follow up | The WPAI is a 6-item questionnaire assessing health-related absenteeism, presenteeism, and activity impairment. Scores are calculated as percentages with higher values indicating greater impairment and lower productivity. |
| Change in Flourishing Index score | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing. |
| PROMIS Sleep Disturbance | baseline, week 1, week 2, week 3, week 4, 6-month follow up | The PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5-point Likert scale with higher scores indicating increased sleep disturbance. It provides t-scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances. |
| Supportive Accountability Inventory (SAI) | week 4, 6-month follow up | The SAI is an 8-item self-report tool to evaluate how users perceive the support and accountability provided by coaches in digital mental health interventions. It uses a 7-point Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). Scores range from 8 to 56. Higher scores indicate a stronger sense of supportive accountability from their coach perceived. |
| Ruminative Response Scale - Brooding subscale score | baseline, week 4, 6-month follow up | The RRS-Brooding subscale is a 5-item, 4-point measure of rumination. Each item indicates the frequency of each event by rating a four-point Likert scale ranging from 1 (Almost never) to 4 (Almost always). The total score ranges from 5-20, with higher scores indicating increased tendency to ruminate. |
| Treatment Expectancy Measure | week 4 | This measure assesses how much the participant believes that the training program was helpful to them. This has two aspects to it: (1) what the participant thought would happen and (2) what the participant feels will happen. Each scale is scored from 1-9 with higher scores indicating better treatment expectancy. |
Countries
United States
Contacts
CONTACTWendy Lau, PhD
PRINCIPAL_INVESTIGATORSimon Goldberg, PhD
UW Madison
Outcome results
None listed