Anxiety Disorders, Depressive Disorder, Eating Disorders
Conditions
Brief summary
The prevalence of mental health problems among college populations has risen steadily in recent decades, with one third of today's students struggling with anxiety, depression, or an eating disorder (ED). Yet, only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach for detecting mental health problems and engaging college students in services. The investigators have developed a transdiagnostic, low-cost mobile health targeted prevention and intervention platform that uses population-level screening for engaging college students in tailored services that address common mental health problems. This care delivery system represents an ideal model given its use of evidence-based mobile programs, a transdiagnostic approach that addresses comorbid mental health issues, and personalized screening and intervention to increase service uptake, enhance engagement, and improve outcomes. Further, this service delivery model harnesses the expertise of an interdisciplinary team of behavioral scientists, college student mental health scholars, technology researchers, and health economists. This work bridges the study team's collective leadership over the past 25 years in successfully implementing a population-based screening program in more than 160 colleges and demonstrating the effectiveness of Internet-based programs for targeted prevention and intervention for anxiety, depression, and EDs. Through this study, Investigators will test the impact of this mobile mental health platform for service delivery in a large-scale trial across a diverse range of U.S. colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or EDs (excluding anorexia nervosa, for which more intensive medical monitoring is warranted) and who are not currently engaged in mental health services will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). Participants in the study will be enrolled for 2 years and asked to complete surveys at baseline, 6 weeks, 6 months, and 2 years.
Interventions
DEVICESilverCloud Health Intervention
SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs for preventing and treating anxiety, depression, and eating disorders as appropriate Participants in this arm will receive the support of a coach to guide them through the program. Participants will be able to communicate with their coach within the program.
Sponsors
National Institute of Mental Health (NIMH)
Palo Alto University
University of Michigan
Penn State University
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergraduate students at participating colleges and universities who are 18 years old and older. * Students who screen has high risk or clinical/subclinical for anxiety, depression, and, eating disorders. * Students who are not currently in treatment, i.e., in the past month
Exclusion criteria
* Students who do not own a smartphone * Students who are currently engaged in mental health treatment * Students with anorexia nervosa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | baseline, 6 weeks, 6 months, and 2 years | Effectiveness of the mobile mental health platform, compared to usual care, in reducing or preventing the number of individuals with mental health disorders (i.e., a positive screen for at least one of anxiety, depression, or eating disorder as the outcome reflecting a clinical case), assessed at 6 months and 2 years, with a primary endpoint of 2 years. Clinical case status will be determined using the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, the Panic Disorder Self Report (PDSR) for panic disorder, the Patient Health Questionnaire-9 (PHQ-9) for depression, and the Stanford-Washington University Eating Disorders Screen for eating disorders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group. | 6 weeks, 6 months, and 2 years | Uptake will be assessed as engaging in at least one session of mental health service use either online or in-person. This will be assessed based on actual use of the mobile program in the intervention condition and self-report of mental health services utilized or by reporting taking a new antidepressant or anti-anxiety medication in the control condition. |
| Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | baseline, 6 weeks, 6 months, and 2 years | Analyses will be conducted within each disorder subgroup separately. We will use the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, this scale has a minimum value of 0 and a maximum value of 13, a lower score means a better outcome. The Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, this scale has a minimum value of 0 and a maximum value of 31, a lower score means a better outcome. The Panic Disorder Self Report (PDSR) for panic disorder, this scale has a minimum value of 0 and a maximum value of 24, a lower score means a better outcome. The Patient Health Questionnaire-9 (PHQ-9) for depression, this scale has a minimum value of 0 and a maximum value of 27, a lower score means a better outcome. The Eating Disorder Examination-Questionnaire (EDE-Q) for eating disorders, this scale has a minimum value of 0 and a maximum value of 6, a lower score means a better outcome. |
| Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | baseline, 6 months, and 2 years | Impairment/quality of life will be assessed using the Short Form-12 Health Survey. This scale has a minimum value of 0 and a maximum value of 100, a higher score means a better outcome for both the physical component and mental component. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Examine if the Mobile Intervention Changes Cognitive-behavioral Therapy (CBT) Skills and if Changes in CBT Skills Are Associated With Clinical Benefit. | baseline, 6 weeks, 6 months, 2 years | Change in CBT skills will be measured using the self-report version of the Skills of Cognitive Therapy Scale. |
| Examine if the Mobile Intervention Changes Avoidance for Individuals With or at High Risk for Anxiety and if Changes in Avoidance Are Associated With Clinical Benefit. | baseline, 6 weeks, 6 months, 2 years | Avoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale. |
| Identify Other Putative Mediators of Change. | baseline, 6 weeks, 6 months, 2 years | To identify other putative mediators of change we will look at early engagement in help services, number of sessions completed, and rapid response. |
| Examine if the Mobile Intervention Changes Behavioral Activation for Individuals With or at High Risk for Depression and if Changes in Behavioral Activation Are Associated With Clinical Benefit. | baseline, 6 weeks, 6 months, 2 years | Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form. |
| Examine if the Mobile Intervention Changes Dietary Restraint and Weight/Shape Concerns for Individuals With or at High Risk for Eating Disorders and if Changes in Dietary Restraint and Weight/Shape Concerns Are Associated With Clinical Benefit | baseline, 6 weeks, 6 months, 2 years | Dietary restraint will be measured using the Eating Disorder Examination-Questionnaire Restraint subscale and change in weight/shape concerns using the Weight Concerns Scale. |
| Examine if the Mobile Intervention Changes in Dysfunctional Cognitions and if Changes in Dysfunctional Cognitions Are Associated With Clinical Benefit. | baseline, 6 weeks, 6 months, 2 years | Change in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile Coached Intervention This group will receive access to the mobile intervention for 6 months. They will be assigned to the primary program (i.e., anxiety, depression, or eating disorders) they screen positive for. If a person screens positive for more than one disorder, they will be given the choice of which program they want to start with. They will also be provided preventive interventions for anxiety, depressive, or eating of disorders they may not have but be at risk for. After two weeks in the program, the coach will assign the components presumed to be essential to intervention effects for comorbid disorder(s) and risk factors.
SilverCloud Health Intervention: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs for preventing and treating anxiety, depression, and eating disorders as appropriate Participants in this arm will receive the support of a coach to guide them through the program. Participants will be able to communicate with their coach within the program. | 3,103 |
| Referral to Counseling Center This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so. | 3,102 |
| Total | 6,205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | Referral to Counseling Center | Total | Mobile Coached Intervention |
|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 4 | 20.2 years STANDARD_DEVIATION 4 | 20.2 years STANDARD_DEVIATION 4 |
| Diagnosis 1 clinical diagnosis | 824 Participants | 1576 Participants | 752 Participants |
| Diagnosis 2 clinical diagnosis | 656 Participants | 1366 Participants | 710 Participants |
| Diagnosis 3 clinical diagnosis | 540 Participants | 1078 Participants | 538 Participants |
| Diagnosis 4 clinical diagnosis | 218 Participants | 449 Participants | 231 Participants |
| Diagnosis 5 clinical diagnosis | 36 Participants | 69 Participants | 33 Participants |
| Diagnosis High risk 0 clinical diagnosis | 828 Participants | 1667 Participants | 839 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 527 Participants | 1046 Participants | 519 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2575 Participants | 5159 Participants | 2584 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 42 Participants | 77 Participants | 35 Participants |
| Race (NIH/OMB) Asian | 466 Participants | 939 Participants | 473 Participants |
| Race (NIH/OMB) Black or African American | 234 Participants | 465 Participants | 231 Participants |
| Race (NIH/OMB) More than one race | 206 Participants | 425 Participants | 219 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2144 Participants | 4278 Participants | 2134 Participants |
| Region of Enrollment United States | 3102 Participants | 6205 Participants | 3103 Participants |
| Sex/Gender, Customized Female | 2179 Participants | 4370 Participants | 2191 Participants |
| Sex/Gender, Customized Male | 811 Participants | 1613 Participants | 802 Participants |
| Sex/Gender, Customized Other | 112 Participants | 222 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,103 | 0 / 3,102 |
| other Total, other adverse events | 0 / 3,103 | 0 / 3,102 |
| serious Total, serious adverse events | 0 / 3,103 | 0 / 3,102 |
Outcome results
Primary
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders.
Effectiveness of the mobile mental health platform, compared to usual care, in reducing or preventing the number of individuals with mental health disorders (i.e., a positive screen for at least one of anxiety, depression, or eating disorder as the outcome reflecting a clinical case), assessed at 6 months and 2 years, with a primary endpoint of 2 years. Clinical case status will be determined using the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, the Panic Disorder Self Report (PDSR) for panic disorder, the Patient Health Questionnaire-9 (PHQ-9) for depression, and the Stanford-Washington University Eating Disorders Screen for eating disorders
Time frame: baseline, 6 weeks, 6 months, and 2 years
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 2 year | Number of participants with at least one clinical mental disorder | 1723 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 month | Number of participants without any clinical mental disorder | 1360 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 2 year | Number of participants without any clinical mental disorder | 1380 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | Baseline | Number of participants with at least one clinical mental disorder | 2264 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | Baseline | Number of participants without any clinical mental disorder | 839 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 weeks | Number of participants with at least one clinical mental disorder | 1764 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 month | Number of participants with at least one clinical mental disorder | 1743 Participants |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 weeks | Number of participants without any clinical mental disorder | 1339 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | Baseline | Number of participants without any clinical mental disorder | 828 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 weeks | Number of participants without any clinical mental disorder | 1206 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 month | Number of participants with at least one clinical mental disorder | 1894 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | Baseline | Number of participants with at least one clinical mental disorder | 2274 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 month | Number of participants without any clinical mental disorder | 1208 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 2 year | Number of participants with at least one clinical mental disorder | 1841 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 6 weeks | Number of participants with at least one clinical mental disorder | 1896 Participants |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders. | 2 year | Number of participants without any clinical mental disorder | 1261 Participants |
Comparison: Baselinep-value: 0.7695% CI: [0.88, 1.1]Regression, Logistic
Comparison: 6 week follow-upp-value: 0.00195% CI: [0.76, 0.93]Regression, Logistic
Comparison: 6 month follow-upp-value: 095% CI: [0.74, 0.9]Regression, Logistic
Comparison: 2 yearp-value: 0.00295% CI: [0.77, 0.95]Regression, Logistic
Secondary
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms.
Analyses will be conducted within each disorder subgroup separately. We will use the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV) for generalized anxiety disorder, this scale has a minimum value of 0 and a maximum value of 13, a lower score means a better outcome. The Social Phobia Diagnostic Questionnaire (SPDQ) for social anxiety disorder, this scale has a minimum value of 0 and a maximum value of 31, a lower score means a better outcome. The Panic Disorder Self Report (PDSR) for panic disorder, this scale has a minimum value of 0 and a maximum value of 24, a lower score means a better outcome. The Patient Health Questionnaire-9 (PHQ-9) for depression, this scale has a minimum value of 0 and a maximum value of 27, a lower score means a better outcome. The Eating Disorder Examination-Questionnaire (EDE-Q) for eating disorders, this scale has a minimum value of 0 and a maximum value of 6, a lower score means a better outcome.
Time frame: baseline, 6 weeks, 6 months, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 Baseline | 11.65 score on a scale | Standard Deviation 5.91 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 6-month | 8.61 score on a scale | Standard Deviation 5.95 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 2-year | 8.29 score on a scale | Standard Deviation 5.79 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV Baseline | 6.56 score on a scale | Standard Deviation 3.98 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 6-week | 5.34 score on a scale | Standard Deviation 3.84 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 6-month | 5.43 score on a scale | Standard Deviation 4.02 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ Baseline | 12.44 score on a scale | Standard Deviation 6.05 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 6-week | 11.63 score on a scale | Standard Deviation 6.16 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 2-year | 11.17 score on a scale | Standard Deviation 6.3 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global Baseline | 1.81 score on a scale | Standard Deviation 1.4 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 6-week | 1.55 score on a scale | Standard Deviation 1.24 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 6-week | 8.32 score on a scale | Standard Deviation 5.52 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 2-year | 5.37 score on a scale | Standard Deviation 3.96 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 6-month | 11.20 score on a scale | Standard Deviation 6.4 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR Baseline | 4.66 score on a scale | Standard Deviation 6.96 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 6-week | 2.69 score on a scale | Standard Deviation 5.75 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 6-month | 3.60 score on a scale | Standard Deviation 6.41 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 2-year | 3.75 score on a scale | Standard Deviation 6.6 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 6-month | 1.48 score on a scale | Standard Deviation 1.22 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 2-year | 1.62 score on a scale | Standard Deviation 1.29 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 6-week | 2.84 score on a scale | Standard Deviation 5.8 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 Baseline | 11.68 score on a scale | Standard Deviation 5.89 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 6-week | 9.43 score on a scale | Standard Deviation 5.76 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 2-year | 1.67 score on a scale | Standard Deviation 1.29 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 6-month | 9.29 score on a scale | Standard Deviation 6.13 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV Baseline | 6.60 score on a scale | Standard Deviation 3.94 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PHQ-9 2-year | 8.73 score on a scale | Standard Deviation 5.74 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 6-month | 3.62 score on a scale | Standard Deviation 6.44 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ Baseline | 12.38 score on a scale | Standard Deviation 6.06 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 6-week | 5.73 score on a scale | Standard Deviation 3.92 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 6-month | 1.69 score on a scale | Standard Deviation 1.33 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 6-month | 5.50 score on a scale | Standard Deviation 4.02 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | GADQ-IV 2-year | 5.49 score on a scale | Standard Deviation 3.93 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 2-year | 11.40 score on a scale | Standard Deviation 6.03 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR 2-year | 3.82 score on a scale | Standard Deviation 6.58 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 6-week | 12.06 score on a scale | Standard Deviation 6.33 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | SPDQ 6-month | 11.53 score on a scale | Standard Deviation 6.41 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | PDSR Baseline | 4.72 score on a scale | Standard Deviation 6.96 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global 6-week | 1.74 score on a scale | Standard Deviation 1.34 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Disorder-specific Symptoms. | EDE-Q-Global Baseline | 1.83 score on a scale | Standard Deviation 1.39 |
Comparison: PHQ-9 6 weekp-value: 0multilevel modeling methods
Comparison: PHQ-9 6 monthsp-value: 0multilevel modeling methods
Comparison: PHQ-9 2 yearp-value: 0.02multilevel modeling methods
Comparison: GADQ-IV 6 weekp-value: 0.002multilevel modeling methods
Comparison: GADQ-IV 6 monthp-value: 0.8multilevel modeling methods
Comparison: GADQ-IV 2 yearp-value: 0.51multilevel modeling methods
Comparison: SPDQ 6 weekp-value: 0.004multilevel modeling methods
Comparison: SPDQ 6 monthp-value: 0.02multilevel modeling methods
Comparison: SPDQ 2 yearp-value: 0.09multilevel modeling methods
Comparison: PDSR 6 weekp-value: 0.66multilevel modeling methods
Comparison: PDSR 6 monthp-value: 0.85multilevel modeling methods
Comparison: PDSR 2 yearp-value: 0.97multilevel modeling methods
Comparison: EDE-Q Global 6 weekp-value: 0multilevel modeling methods
Comparison: EDE-Q Global 6 monthp-value: 0multilevel modeling methods
Comparison: EDE-Q Global 2 yearp-value: 0.54multilevel modeling methods
Secondary
Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning.
Impairment/quality of life will be assessed using the Short Form-12 Health Survey. This scale has a minimum value of 0 and a maximum value of 100, a higher score means a better outcome for both the physical component and mental component.
Time frame: baseline, 6 months, and 2 years
Population: Analysis we ran separately for the mental component summary (MCS) and the physical component summary (PCS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS 6 months | 36.41 score on a scale | Standard Deviation 11.49 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS Baseline | 34.11 score on a scale | Standard Deviation 10.73 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS 2 years | 37.85 score on a scale | Standard Deviation 11.33 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS Baseline | 53.65 score on a scale | Standard Deviation 7.63 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS 6 months | 63.21 score on a scale | Standard Deviation 8.55 |
| Mobile Coached Intervention | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS 2 years | 53.15 score on a scale | Standard Deviation 7.84 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS 6 months | 53.43 score on a scale | Standard Deviation 8.31 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS Baseline | 53.85 score on a scale | Standard Deviation 7.3 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS Baseline | 33.89 score on a scale | Standard Deviation 10.69 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS 6 months | 35.95 score on a scale | Standard Deviation 11.63 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | PCS 2 years | 53.42 score on a scale | Standard Deviation 7.87 |
| Referral to Counseling Center | Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing Quality of Life and Functioning. | MCS 2 years | 36.93 score on a scale | Standard Deviation 11.4 |
Comparison: Mental component summary 6 monthsp-value: 0.48multilevel modeling methods
Comparison: Mental component summary 2 yearsp-value: 0.04multilevel modeling methods
Comparison: Physical component summary 6 monthsp-value: 0.97multilevel modeling methods
Comparison: Physical component summary 2 yearsp-value: 0.8multilevel modeling methods
Secondary
Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group.
Uptake will be assessed as engaging in at least one session of mental health service use either online or in-person. This will be assessed based on actual use of the mobile program in the intervention condition and self-report of mental health services utilized or by reporting taking a new antidepressant or anti-anxiety medication in the control condition.
Time frame: 6 weeks, 6 months, and 2 years
Population: Intervention: proportion of individuals who accessed the digital intervention platform during the 6 months post baseline period (this outcome was not relevant at 2 years for this condition).~Control: proportion of individuals who, for 6 month and 2 year follow-up assessments, reported having had at least 1 session of counseling or psychotherapy or having started a new antidepressant or anti-anxiety medication (i.e., were not taking these medications at baseline).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobile Coached Intervention | Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group. | 6 month follow-up | 2308 Participants |
| Referral to Counseling Center | Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group. | 6 month follow-up | 938 Participants |
| Referral to Counseling Center | Number of Participants Who Receive Treatment on the Mobile Mental Health Platform Compared to Number of Participants Who Receive Treatment in the Control Group. | 2 year follow-up | 1904 Participants |
Comparison: A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.p-value: 095% CI: [5.98, 7.5]Chi-squared
Comparison: A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.p-value: 095% CI: [1.64, 2.04]Chi-squared
Other Pre-specified
Examine if the Mobile Intervention Changes Avoidance for Individuals With or at High Risk for Anxiety and if Changes in Avoidance Are Associated With Clinical Benefit.
Avoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale.
Time frame: baseline, 6 weeks, 6 months, 2 years
Other Pre-specified
Examine if the Mobile Intervention Changes Behavioral Activation for Individuals With or at High Risk for Depression and if Changes in Behavioral Activation Are Associated With Clinical Benefit.
Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form.
Time frame: baseline, 6 weeks, 6 months, 2 years
Other Pre-specified
Examine if the Mobile Intervention Changes Cognitive-behavioral Therapy (CBT) Skills and if Changes in CBT Skills Are Associated With Clinical Benefit.
Change in CBT skills will be measured using the self-report version of the Skills of Cognitive Therapy Scale.
Time frame: baseline, 6 weeks, 6 months, 2 years
Other Pre-specified
Examine if the Mobile Intervention Changes Dietary Restraint and Weight/Shape Concerns for Individuals With or at High Risk for Eating Disorders and if Changes in Dietary Restraint and Weight/Shape Concerns Are Associated With Clinical Benefit
Dietary restraint will be measured using the Eating Disorder Examination-Questionnaire Restraint subscale and change in weight/shape concerns using the Weight Concerns Scale.
Time frame: baseline, 6 weeks, 6 months, 2 years
Other Pre-specified
Examine if the Mobile Intervention Changes in Dysfunctional Cognitions and if Changes in Dysfunctional Cognitions Are Associated With Clinical Benefit.
Change in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2.
Time frame: baseline, 6 weeks, 6 months, 2 years
Other Pre-specified
Identify Other Putative Mediators of Change.
To identify other putative mediators of change we will look at early engagement in help services, number of sessions completed, and rapid response.
Time frame: baseline, 6 weeks, 6 months, 2 years