Trial Outcomes & Findings for Providing Mental Health Precision Treatment (NCT NCT04342494)

Last Updated: 2025-03-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

2118 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2025-03-17

Participant Flow

2118 participants were consented for this trial. Of that number, 2079 completed baseline and were randomized.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.
Overall Study STARTED	690	349	349	345	346
Overall Study COMPLETED	640	311	313	311	310
Overall Study NOT COMPLETED	50	38	36	34	36

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.
Overall Study Lost to Follow-up	49	38	34	34	35
Overall Study Questionnaire partially completed	1	0	2	0	1

Baseline Characteristics

Providing Mental Health Precision Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Feedback + Standard Feedback n=690 Participants 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.	Headspace App + Standard Feedback n=349 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=349 Participants 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.	SilverCloud App + Standard Feedback n=345 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=346 Participants 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.	Total n=2079 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 14.5 • n=5 Participants	36.2 years STANDARD_DEVIATION 14.4 • n=7 Participants	36.8 years STANDARD_DEVIATION 14.5 • n=5 Participants	36.8 years STANDARD_DEVIATION 13.7 • n=4 Participants	36.5 years STANDARD_DEVIATION 14.3 • n=21 Participants	36.8 years STANDARD_DEVIATION 14.3 • n=8 Participants
Sex/Gender, Customized Male	192 Participants n=5 Participants	80 Participants n=7 Participants	106 Participants n=5 Participants	89 Participants n=4 Participants	93 Participants n=21 Participants	560 Participants n=8 Participants
Sex/Gender, Customized Female	491 Participants n=5 Participants	267 Participants n=7 Participants	242 Participants n=5 Participants	251 Participants n=4 Participants	248 Participants n=21 Participants	1499 Participants n=8 Participants
Sex/Gender, Customized Unknown	7 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	20 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	28 Participants n=7 Participants	31 Participants n=5 Participants	24 Participants n=4 Participants	15 Participants n=21 Participants	142 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	641 Participants n=5 Participants	318 Participants n=7 Participants	314 Participants n=5 Participants	319 Participants n=4 Participants	328 Participants n=21 Participants	1920 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	17 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Asian	44 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	23 Participants n=21 Participants	118 Participants n=8 Participants
Race/Ethnicity, Customized Black	57 Participants n=5 Participants	33 Participants n=7 Participants	23 Participants n=5 Participants	31 Participants n=4 Participants	18 Participants n=21 Participants	162 Participants n=8 Participants
Race/Ethnicity, Customized White	516 Participants n=5 Participants	269 Participants n=7 Participants	275 Participants n=5 Participants	259 Participants n=4 Participants	271 Participants n=21 Participants	1590 Participants n=8 Participants
Race/Ethnicity, Customized Multiple races	38 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	16 Participants n=21 Participants	99 Participants n=8 Participants
Race/Ethnicity, Customized Other	27 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants	11 Participants n=21 Participants	78 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	24 Participants n=8 Participants
Region of Enrollment United States	690 Participants n=5 Participants	349 Participants n=7 Participants	349 Participants n=5 Participants	345 Participants n=4 Participants	346 Participants n=21 Participants	2079 Participants n=8 Participants
Sexual Orientation Heterosexual	495 Participants n=5 Participants	241 Participants n=7 Participants	253 Participants n=5 Participants	236 Participants n=4 Participants	223 Participants n=21 Participants	1448 Participants n=8 Participants
Sexual Orientation Bisexual	91 Participants n=5 Participants	53 Participants n=7 Participants	44 Participants n=5 Participants	50 Participants n=4 Participants	63 Participants n=21 Participants	301 Participants n=8 Participants
Sexual Orientation Gay or lesbian	29 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	27 Participants n=4 Participants	17 Participants n=21 Participants	105 Participants n=8 Participants
Sexual Orientation Other	35 Participants n=5 Participants	24 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	22 Participants n=21 Participants	110 Participants n=8 Participants
Sexual Orientation Multiple identities	20 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	56 Participants n=8 Participants
Sexual Orientation Unknown	20 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	11 Participants n=21 Participants	59 Participants n=8 Participants
Employment Status Full-time	261 Participants n=5 Participants	136 Participants n=7 Participants	150 Participants n=5 Participants	141 Participants n=4 Participants	137 Participants n=21 Participants	825 Participants n=8 Participants
Employment Status Part-time	140 Participants n=5 Participants	61 Participants n=7 Participants	61 Participants n=5 Participants	66 Participants n=4 Participants	71 Participants n=21 Participants	399 Participants n=8 Participants
Employment Status Retired	53 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	21 Participants n=21 Participants	139 Participants n=8 Participants
Employment Status Student	91 Participants n=5 Participants	53 Participants n=7 Participants	42 Participants n=5 Participants	45 Participants n=4 Participants	47 Participants n=21 Participants	278 Participants n=8 Participants
Employment Status Unemployed	143 Participants n=5 Participants	75 Participants n=7 Participants	75 Participants n=5 Participants	72 Participants n=4 Participants	70 Participants n=21 Participants	435 Participants n=8 Participants
Employment Status Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Educational Level <High school diploma	14 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	48 Participants n=8 Participants
Educational Level High school diploma or GED	68 Participants n=5 Participants	38 Participants n=7 Participants	37 Participants n=5 Participants	44 Participants n=4 Participants	38 Participants n=21 Participants	225 Participants n=8 Participants
Educational Level Some College	165 Participants n=5 Participants	98 Participants n=7 Participants	85 Participants n=5 Participants	86 Participants n=4 Participants	85 Participants n=21 Participants	519 Participants n=8 Participants
Educational Level Associate degree or TVS	88 Participants n=5 Participants	45 Participants n=7 Participants	52 Participants n=5 Participants	37 Participants n=4 Participants	39 Participants n=21 Participants	261 Participants n=8 Participants
Educational Level Bachelor's degree	207 Participants n=5 Participants	84 Participants n=7 Participants	95 Participants n=5 Participants	84 Participants n=4 Participants	94 Participants n=21 Participants	564 Participants n=8 Participants
Educational Level ≥Master's degree	146 Participants n=5 Participants	77 Participants n=7 Participants	68 Participants n=5 Participants	87 Participants n=4 Participants	80 Participants n=21 Participants	458 Participants n=8 Participants
Educational Level Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Gender Identity Man	192 Participants n=5 Participants	78 Participants n=7 Participants	97 Participants n=5 Participants	84 Participants n=4 Participants	88 Participants n=21 Participants	539 Participants n=8 Participants
Gender Identity Woman	466 Participants n=5 Participants	248 Participants n=7 Participants	231 Participants n=5 Participants	242 Participants n=4 Participants	236 Participants n=21 Participants	1423 Participants n=8 Participants
Gender Identity Transgender and Nonbinary (TGNB)	28 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	18 Participants n=4 Participants	20 Participants n=21 Participants	106 Participants n=8 Participants
Gender Identity Unknown	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Feedback + Standard Feedback n=690 Participants 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.	Headspace App + Standard Feedback n=349 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=349 Participants 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.	SilverCloud App + Standard Feedback n=345 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=346 Participants 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.
Change in Depression as Measured by the Patient Health Questionnaire 9 (PHQ-9) Baseline	12.6 score on a scale Standard Deviation 6.4	12.5 score on a scale Standard Deviation 6.3	13.0 score on a scale Standard Deviation 6.8	13.0 score on a scale Standard Deviation 6.2	12.8 score on a scale Standard Deviation 6.4
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	9.8 score on a scale Standard Deviation 5.9	10.1 score on a scale Standard Deviation 5.9	10.3 score on a scale Standard Deviation 5.9	10.6 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: Daily up to 6 weeks

Population: Only participants who completed their mood scores between weeks 2 and 6 were analyzed.

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.

Outcome measures

Outcome measures
Measure	Enhanced Feedback + Standard Feedback n=681 Participants 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.	Headspace App + Standard Feedback n=346 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=344 Participants 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.	SilverCloud App + Standard Feedback n=340 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=341 Participants 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.
Mood as Measured by the Mental Health App Assessment	6.2 score on a scale Standard Deviation 1.4	6.1 score on a scale Standard Deviation 1.3	6.2 score on a scale Standard Deviation 1.4	6.0 score on a scale Standard Deviation 1.3	5.9 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Feedback + Standard Feedback n=690 Participants 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.	Headspace App + Standard Feedback n=349 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=349 Participants 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.	SilverCloud App + Standard Feedback n=345 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=346 Participants 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.
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 5.0	18.4 score on a scale Standard Deviation 5.1	17.9 score on a scale Standard Deviation 5.1	18.2 score on a scale Standard Deviation 4.9	17.8 score on a scale Standard Deviation 5.3
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	19.6 score on a scale Standard Deviation 5.6	19.0 score on a scale Standard Deviation 5.1	18.8 score on a scale Standard Deviation 4.9	18.2 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Feedback + Standard Feedback n=690 Participants 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.	Headspace App + Standard Feedback n=349 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=349 Participants 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.	SilverCloud App + Standard Feedback n=345 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=346 Participants 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.
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	11.0 score on a scale Standard Deviation 5.6	12.2 score on a scale Standard Deviation 6.8	11.6 score on a scale Standard Deviation 6.8	11.7 score on a scale Standard Deviation 6.3
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	9.9 score on a scale Standard Deviation 4.4	10.8 score on a scale Standard Deviation 5.5	10.5 score on a scale Standard Deviation 5.5	10.6 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Enhanced Feedback + Standard Feedback n=690 Participants 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.	Headspace App + Standard Feedback n=349 Participants 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.	Headspace App + Enhanced Feedback + Standard Feedback n=349 Participants 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.	SilverCloud App + Standard Feedback n=345 Participants 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.	SilverCloud App +Enhanced Feedback +Standard Feedback n=346 Participants 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.
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	11.6 score on a scale Standard Deviation 5.8	11.4 score on a scale Standard Deviation 5.9	11.9 score on a scale Standard Deviation 6.0	11.8 score on a scale Standard Deviation 5.8
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	9.5 score on a scale Standard Deviation 5.4	9.7 score on a scale Standard Deviation 5.7	10.0 score on a scale Standard Deviation 5.6	9.8 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: 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.