Trial Outcomes & Findings for Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations (NCT NCT04162847)
NCT ID: NCT04162847
Last Updated: 2025-04-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6205 participants
Primary outcome timeframe
baseline, 6 weeks, 6 months, and 2 years
Results posted on
2025-04-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3103
|
3102
|
|
Overall Study
Completed 6-week Follow-up Assessment
|
1386
|
1792
|
|
Overall Study
Completed 6-month Follow-up Assessment
|
1363
|
1669
|
|
Overall Study
Completed 2-year Follow-up Assessment
|
1627
|
1765
|
|
Overall Study
COMPLETED
|
3096
|
3101
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
Baseline Characteristics
Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations
Baseline characteristics by cohort
| Measure |
Mobile Coached Intervention
n=3103 Participants
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.
|
Referral to Counseling Center
n=3102 Participants
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
|
Total
n=6205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
20.2 years
STANDARD_DEVIATION 4.0 • n=7 Participants
|
20.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
802 Participants
n=5 Participants
|
811 Participants
n=7 Participants
|
1613 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
2191 Participants
n=5 Participants
|
2179 Participants
n=7 Participants
|
4370 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
110 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
519 Participants
n=5 Participants
|
527 Participants
n=7 Participants
|
1046 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2584 Participants
n=5 Participants
|
2575 Participants
n=7 Participants
|
5159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
473 Participants
n=5 Participants
|
466 Participants
n=7 Participants
|
939 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
231 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2134 Participants
n=5 Participants
|
2144 Participants
n=7 Participants
|
4278 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
219 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
425 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3103 Participants
n=5 Participants
|
3102 Participants
n=7 Participants
|
6205 Participants
n=5 Participants
|
|
Diagnosis
High risk 0 clinical diagnosis
|
839 Participants
n=5 Participants
|
828 Participants
n=7 Participants
|
1667 Participants
n=5 Participants
|
|
Diagnosis
1 clinical diagnosis
|
752 Participants
n=5 Participants
|
824 Participants
n=7 Participants
|
1576 Participants
n=5 Participants
|
|
Diagnosis
2 clinical diagnosis
|
710 Participants
n=5 Participants
|
656 Participants
n=7 Participants
|
1366 Participants
n=5 Participants
|
|
Diagnosis
3 clinical diagnosis
|
538 Participants
n=5 Participants
|
540 Participants
n=7 Participants
|
1078 Participants
n=5 Participants
|
|
Diagnosis
4 clinical diagnosis
|
231 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
Diagnosis
5 clinical diagnosis
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 2 yearsEffectiveness 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
Outcome measures
| Measure |
Mobile Coached Intervention
n=3103 Participants
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.
|
Referral to Counseling Center
n=3102 Participants
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
|
|---|---|---|
|
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
|
2274 Participants
|
|
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
|
828 Participants
|
|
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
|
1896 Participants
|
|
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
|
1206 Participants
|
|
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
|
1894 Participants
|
|
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
|
1208 Participants
|
|
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
|
1841 Participants
|
|
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
|
1261 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months, and 2 yearsPopulation: 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).
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.
Outcome measures
| Measure |
Mobile Coached Intervention
n=3103 Participants
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.
|
Referral to Counseling Center
n=3102 Participants
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
|
|---|---|---|
|
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
|
938 Participants
|
|
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
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 2 yearsAnalyses 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.
Outcome measures
| Measure |
Mobile Coached Intervention
n=3103 Participants
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.
|
Referral to Counseling Center
n=3102 Participants
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
|
|---|---|---|
|
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
|
11.68 score on a scale
Standard Deviation 5.89
|
|
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
|
9.43 score on a scale
Standard Deviation 5.76
|
|
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
|
9.29 score on a scale
Standard Deviation 6.13
|
|
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
|
8.73 score on a scale
Standard Deviation 5.74
|
|
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
|
6.60 score on a scale
Standard Deviation 3.94
|
|
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
|
5.73 score on a scale
Standard Deviation 3.92
|
|
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
|
5.50 score on a scale
Standard Deviation 4.02
|
|
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
|
5.49 score on a scale
Standard Deviation 3.93
|
|
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
|
12.38 score on a scale
Standard Deviation 6.06
|
|
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
|
12.06 score on a scale
Standard Deviation 6.33
|
|
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 6.40
|
11.53 score on a scale
Standard Deviation 6.41
|
|
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 6.30
|
11.40 score on a scale
Standard Deviation 6.03
|
|
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
|
4.72 score on a scale
Standard Deviation 6.96
|
|
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
|
2.84 score on a scale
Standard Deviation 5.80
|
|
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
|
3.62 score on a scale
Standard Deviation 6.44
|
|
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 6.60
|
3.82 score on a scale
Standard Deviation 6.58
|
|
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 1.40
|
1.83 score on a scale
Standard Deviation 1.39
|
|
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
|
1.74 score on a scale
Standard Deviation 1.34
|
|
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
|
1.69 score on a scale
Standard Deviation 1.33
|
|
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
|
1.67 score on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: baseline, 6 months, and 2 yearsPopulation: Analysis we ran separately for the mental component summary (MCS) and the physical component summary (PCS).
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.
Outcome measures
| Measure |
Mobile Coached Intervention
n=3103 Participants
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.
|
Referral to Counseling Center
n=3102 Participants
This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so.
|
|---|---|---|
|
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
|
33.89 score on a scale
Standard Deviation 10.69
|
|
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
|
35.95 score on a scale
Standard Deviation 11.63
|
|
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
|
36.93 score on a scale
Standard Deviation 11.40
|
|
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
|
53.85 score on a scale
Standard Deviation 7.30
|
|
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
|
53.43 score on a scale
Standard Deviation 8.31
|
|
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
|
53.42 score on a scale
Standard Deviation 7.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsAvoidance will be measured using item 3 of the Overall Anxiety and Impairment Scale.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsBehavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsDietary restraint will be measured using the Eating Disorder Examination-Questionnaire Restraint subscale and change in weight/shape concerns using the Weight Concerns Scale.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsChange in dysfunctional cognition will be measured using the Dysfunctional Attitude Scale Short form-2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsChange in CBT skills will be measured using the self-report version of the Skills of Cognitive Therapy Scale.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 6 weeks, 6 months, 2 yearsTo identify other putative mediators of change we will look at early engagement in help services, number of sessions completed, and rapid response.
Outcome measures
Outcome data not reported
Adverse Events
Mobile Coached Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Referral to Counseling Center
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Denise Wilfley
Washington University in St. Louis School of Medicine
Phone: 3142862079
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place