Addiction, Anxiety, Depression, Sleep Disturbance
Conditions
Keywords
Behavioral health, Precision health
Brief summary
This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments, and to understand which patients receive the most benefit.
Detailed description
Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.
Interventions
BEHAVIORALEnhanced Feedback + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.
DEVICEHeadspace app + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Headspace is an app designed to train the user in mindfulness practices.
DEVICEHeadspace app + Enhanced Feedback + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback. Headspace is an app designed to train the user in mindfulness practices.
DEVICESilverCloud + Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Silvercloud is an app designed to deliver cognitive behavioral therapy.
DEVICESilverCloud app +Enhanced Feedback +Standard Feedback
Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself. Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback. Silvercloud is an app designed to deliver cognitive behavioral therapy.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan * Must have daily access to a smartphone version that is compatible with study activity trackers. * Understands English to enable consent and use of the MyDataHelps app and app-based interventions * Provide complete, updated contact information upon enrollment to the study * Agree to be contacted by study staff during the study * Willingness to keep study setup (devices, apps, settings) in required configuration for the duration of the study, and following instructions by study staff if required to update or re-achieve required configuration if required configuration has been lost (e.g., change of phone, app deletion)
Exclusion criteria
* Self-reported or medical record indication of a current eating disorder * Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+) * Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Up to 6 weeks | The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood as Measured by the Mental Health App Assessment | Daily up to 6 weeks | Participants were asked a single question, On a scale of 1 to 10, what was your average mood today? Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods. |
| Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Up to 6 weeks | The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior. |
| Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Up to 6 weeks | The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior. |
| Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Up to 6 weeks | GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively. |
| Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Up to 6 weeks | The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked. |
Countries
United States
Participant flow
Pre-assignment details
2118 participants were consented for this trial. Of that number, 2079 completed baseline and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Feedback + Standard Feedback Participants will receive enhanced feedback from the MyDataHelps study app in addition to standard feedback from the activity tracker.
Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback. | 690 |
| Headspace App + Standard Feedback Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
Headspace app + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Headspace is an app designed to train the user in mindfulness practices. | 349 |
| Headspace App + Enhanced Feedback + Standard Feedback Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback activity tracker.
Headspace app + Enhanced Feedback + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.
Headspace is an app designed to train the user in mindfulness practices. | 349 |
| SilverCloud App + Standard Feedback Participants will receive an app-based intervention in addition to standard feedback from the activity tracker.
SilverCloud + Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Silvercloud is an app designed to deliver cognitive behavioral therapy. | 345 |
| SilverCloud App +Enhanced Feedback +Standard Feedback Participants will receive an app-based intervention, enhanced feedback from the MyDataHelps study app, and standard feedback from the activity tracker.
SilverCloud app +Enhanced Feedback +Standard Feedback: Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.
Silvercloud is an app designed to deliver cognitive behavioral therapy. | 346 |
| Total | 2,079 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 49 | 38 | 34 | 34 | 35 |
| Overall Study | Questionnaire partially completed | 1 | 0 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Headspace App + Standard Feedback | Headspace App + Enhanced Feedback + Standard Feedback | SilverCloud App + Standard Feedback | SilverCloud App +Enhanced Feedback +Standard Feedback | Enhanced Feedback + Standard Feedback | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 14.4 | 36.8 years STANDARD_DEVIATION 14.5 | 36.8 years STANDARD_DEVIATION 13.7 | 36.5 years STANDARD_DEVIATION 14.3 | 37.3 years STANDARD_DEVIATION 14.5 | 36.8 years STANDARD_DEVIATION 14.3 |
| Educational Level Associate degree or TVS | 45 Participants | 52 Participants | 37 Participants | 39 Participants | 88 Participants | 261 Participants |
| Educational Level Bachelor's degree | 84 Participants | 95 Participants | 84 Participants | 94 Participants | 207 Participants | 564 Participants |
| Educational Level <High school diploma | 7 Participants | 12 Participants | 6 Participants | 9 Participants | 14 Participants | 48 Participants |
| Educational Level High school diploma or GED | 38 Participants | 37 Participants | 44 Participants | 38 Participants | 68 Participants | 225 Participants |
| Educational Level ≥Master's degree | 77 Participants | 68 Participants | 87 Participants | 80 Participants | 146 Participants | 458 Participants |
| Educational Level Some College | 98 Participants | 85 Participants | 86 Participants | 85 Participants | 165 Participants | 519 Participants |
| Educational Level Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Employment Status Full-time | 136 Participants | 150 Participants | 141 Participants | 137 Participants | 261 Participants | 825 Participants |
| Employment Status Part-time | 61 Participants | 61 Participants | 66 Participants | 71 Participants | 140 Participants | 399 Participants |
| Employment Status Retired | 24 Participants | 21 Participants | 20 Participants | 21 Participants | 53 Participants | 139 Participants |
| Employment Status Student | 53 Participants | 42 Participants | 45 Participants | 47 Participants | 91 Participants | 278 Participants |
| Employment Status Unemployed | 75 Participants | 75 Participants | 72 Participants | 70 Participants | 143 Participants | 435 Participants |
| Employment Status Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 31 Participants | 24 Participants | 15 Participants | 44 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 318 Participants | 314 Participants | 319 Participants | 328 Participants | 641 Participants | 1920 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 17 Participants |
| Gender Identity Man | 78 Participants | 97 Participants | 84 Participants | 88 Participants | 192 Participants | 539 Participants |
| Gender Identity Transgender and Nonbinary (TGNB) | 19 Participants | 21 Participants | 18 Participants | 20 Participants | 28 Participants | 106 Participants |
| Gender Identity Unknown | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 11 Participants |
| Gender Identity Woman | 248 Participants | 231 Participants | 242 Participants | 236 Participants | 466 Participants | 1423 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 17 Participants | 17 Participants | 23 Participants | 44 Participants | 118 Participants |
| Race/Ethnicity, Customized Black | 33 Participants | 23 Participants | 31 Participants | 18 Participants | 57 Participants | 162 Participants |
| Race/Ethnicity, Customized Multiple races | 12 Participants | 16 Participants | 17 Participants | 16 Participants | 38 Participants | 99 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 11 Participants | 16 Participants | 11 Participants | 27 Participants | 78 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 6 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 269 Participants | 275 Participants | 259 Participants | 271 Participants | 516 Participants | 1590 Participants |
| Region of Enrollment United States | 349 Participants | 349 Participants | 345 Participants | 346 Participants | 690 Participants | 2079 Participants |
| Sex/Gender, Customized Female | 267 Participants | 242 Participants | 251 Participants | 248 Participants | 491 Participants | 1499 Participants |
| Sex/Gender, Customized Male | 80 Participants | 106 Participants | 89 Participants | 93 Participants | 192 Participants | 560 Participants |
| Sex/Gender, Customized Unknown | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 7 Participants | 20 Participants |
| Sexual Orientation Bisexual | 53 Participants | 44 Participants | 50 Participants | 63 Participants | 91 Participants | 301 Participants |
| Sexual Orientation Gay or lesbian | 14 Participants | 18 Participants | 27 Participants | 17 Participants | 29 Participants | 105 Participants |
| Sexual Orientation Heterosexual | 241 Participants | 253 Participants | 236 Participants | 223 Participants | 495 Participants | 1448 Participants |
| Sexual Orientation Multiple identities | 8 Participants | 10 Participants | 8 Participants | 10 Participants | 20 Participants | 56 Participants |
| Sexual Orientation Other | 24 Participants | 13 Participants | 16 Participants | 22 Participants | 35 Participants | 110 Participants |
| Sexual Orientation Unknown | 9 Participants | 11 Participants | 8 Participants | 11 Participants | 20 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 690 | 0 / 349 | 0 / 349 | 0 / 345 | 0 / 346 |
| other Total, other adverse events | 0 / 690 | 0 / 349 | 0 / 349 | 0 / 345 | 0 / 346 |
| serious Total, serious adverse events | 0 / 690 | 0 / 349 | 0 / 349 | 0 / 345 | 0 / 346 |
Outcome results
Primary
Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 was a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporated self-report questions on 9 specific depression symptoms that align with the DSM-IV depression diagnostic criteria. PHQ-9 scores ranged from 0-27, with 0 indicating no depression and 27 indicating severe depression.
Time frame: Up to 6 weeks
Population: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 12.6 score on a scale | Standard Deviation 6.4 |
| Enhanced Feedback + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | 6 weeks | 10.1 score on a scale | Standard Deviation 5.8 |
| Headspace App + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 12.5 score on a scale | Standard Deviation 6.3 |
| Headspace App + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | 6 weeks | 9.8 score on a scale | Standard Deviation 5.9 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 13.0 score on a scale | Standard Deviation 6.8 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | 6 weeks | 10.1 score on a scale | Standard Deviation 5.9 |
| SilverCloud App + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | 6 weeks | 10.3 score on a scale | Standard Deviation 5.9 |
| SilverCloud App + Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 13.0 score on a scale | Standard Deviation 6.2 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | Baseline | 12.8 score on a scale | Standard Deviation 6.4 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) | 6 weeks | 10.6 score on a scale | Standard Deviation 5.7 |
p-value: 0.31ANCOVA
Secondary
Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale
GAD-7 consisted of the total score for seven items ranging from 0 to 21. Scores of 5, 10, and 15 represented cut points for mild, moderate, and severe anxiety, respectively.
Time frame: Up to 6 weeks
Population: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline | 11.5 score on a scale | Standard Deviation 5.8 |
| Enhanced Feedback + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 6 weeks | 9.9 score on a scale | Standard Deviation 5.9 |
| Headspace App + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline | 11.6 score on a scale | Standard Deviation 5.8 |
| Headspace App + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 6 weeks | 9.5 score on a scale | Standard Deviation 5.4 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline | 11.4 score on a scale | Standard Deviation 5.9 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 6 weeks | 9.7 score on a scale | Standard Deviation 5.7 |
| SilverCloud App + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 6 weeks | 10.0 score on a scale | Standard Deviation 5.6 |
| SilverCloud App + Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline | 11.9 score on a scale | Standard Deviation 6 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Baseline | 11.8 score on a scale | Standard Deviation 5.8 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Anxiety as Measured Using the Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 6 weeks | 9.8 score on a scale | Standard Deviation 5.7 |
p-value: 0.31ANCOVA
Secondary
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI)
The PANSI-NSI subscale was composed of 8 items. The possible total score on the PANSI-NSI ranged from 8 to 40. Higher scores on the PANSI-NSI reflected greater risk for suicidal behavior.
Time frame: Up to 6 weeks
Population: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Baseline | 11.1 score on a scale | Standard Deviation 5.8 |
| Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | 6 weeks | 9.9 score on a scale | Standard Deviation 4.6 |
| Headspace App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Baseline | 11.0 score on a scale | Standard Deviation 5.6 |
| Headspace App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | 6 weeks | 9.9 score on a scale | Standard Deviation 4.4 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Baseline | 12.2 score on a scale | Standard Deviation 6.8 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | 6 weeks | 10.8 score on a scale | Standard Deviation 5.5 |
| SilverCloud App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | 6 weeks | 10.5 score on a scale | Standard Deviation 5.5 |
| SilverCloud App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Baseline | 11.6 score on a scale | Standard Deviation 6.8 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | Baseline | 11.7 score on a scale | Standard Deviation 6.3 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Negative Suicide Ideation (PANSI-NSI) | 6 weeks | 10.6 score on a scale | Standard Deviation 5 |
p-value: 0.71ANCOVA
Secondary
Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI)
The PANSI-PI subscale consisted of 6 items. The possible total scores on the PANSI-PI subscale ranged from 6 to 30. Lower scores on the PANSI-PI reflected greater risk for suicidal behavior.
Time frame: Up to 6 weeks
Population: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Baseline | 18.4 score on a scale | Standard Deviation 5 |
| Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | 6 weeks | 19.1 score on a scale | Standard Deviation 5.3 |
| Headspace App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Baseline | 18.4 score on a scale | Standard Deviation 5.1 |
| Headspace App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | 6 weeks | 19.6 score on a scale | Standard Deviation 5.6 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Baseline | 17.9 score on a scale | Standard Deviation 5.1 |
| Headspace App + Enhanced Feedback + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | 6 weeks | 19.0 score on a scale | Standard Deviation 5.1 |
| SilverCloud App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | 6 weeks | 18.8 score on a scale | Standard Deviation 4.9 |
| SilverCloud App + Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Baseline | 18.2 score on a scale | Standard Deviation 4.9 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | Baseline | 17.8 score on a scale | Standard Deviation 5.3 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Change in Suicide Risk as Measured by the Positive and Negative Suicide Ideation Inventory - Positive Ideation (PANSI-PI) | 6 weeks | 18.2 score on a scale | Standard Deviation 5.3 |
p-value: 0.03ANCOVA
Secondary
Mood as Measured by the Mental Health App Assessment
Participants were asked a single question, On a scale of 1 to 10, what was your average mood today? Scores were averaged over follow-up periods with lower scores indicating worse moods and higher scores indicating better moods.
Time frame: Daily up to 6 weeks
Population: Only participants who completed their mood scores between weeks 2 and 6 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Mood as Measured by the Mental Health App Assessment | 6.2 score on a scale | Standard Deviation 1.4 |
| Headspace App + Standard Feedback | Mood as Measured by the Mental Health App Assessment | 6.1 score on a scale | Standard Deviation 1.3 |
| Headspace App + Enhanced Feedback + Standard Feedback | Mood as Measured by the Mental Health App Assessment | 6.2 score on a scale | Standard Deviation 1.4 |
| SilverCloud App + Standard Feedback | Mood as Measured by the Mental Health App Assessment | 6.0 score on a scale | Standard Deviation 1.3 |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Mood as Measured by the Mental Health App Assessment | 5.9 score on a scale | Standard Deviation 1.4 |
p-value: 0.0073ANOVA
Secondary
Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
The ASSIST Global Continuum of Illicit Drug Risk Score ranged from 0 to 308, with higher scores indicating greater risk. Results reflect the participants who indicated they had consumed any alcohol, smoked, or used an illicit substance when asked.
Time frame: Up to 6 weeks
Population: Some participants in each arm were lost to follow up or did not complete their questionnaires following the baseline visit. 1 participant's data for the PHQ-9 was missing, but their data for Outcome Measures 3, 4, 5, and 6 was present.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Feedback + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Baseline | 560 Participants |
| Enhanced Feedback + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 6 weeks | 510 Participants |
| Headspace App + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Baseline | 300 Participants |
| Headspace App + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 6 weeks | 253 Participants |
| Headspace App + Enhanced Feedback + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Baseline | 303 Participants |
| Headspace App + Enhanced Feedback + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 6 weeks | 263 Participants |
| SilverCloud App + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 6 weeks | 255 Participants |
| SilverCloud App + Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Baseline | 287 Participants |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | Baseline | 285 Participants |
| SilverCloud App +Enhanced Feedback +Standard Feedback | Substance Use as Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 6 weeks | 247 Participants |