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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH115128 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Palo Alto University | OTHER |
| University of Michigan | OTHER |
| Penn State University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Coached Intervention | Experimental | 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. |
|
| Referral to Counseling Center | No Intervention | This group will receive information about how to make an appointment at their counseling center and will be encouraged to do so. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SilverCloud Health Intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 6 weeks, 6 months, and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 weeks, 6 months, 2 years |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Wilfley, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto University | Palo Alto | California | 94304 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42098266 | Derived | Newman MG, Fitzsimmons-Craft EE, Baik SY, Zainal NH, Calderon A, Rackoff GN, Firebaugh ML, Rojas-Ashe E, Leykin Y, Lew D, Eisenberg D, Taylor CB, Wilfley DE. Population-based RCT of a digital cognitive-behavioural guided self-help intervention for anxiety, depression and eating disorders in college students. Nat Hum Behav. 2026 May 7:10.1038/s41562-026-02454-z. doi: 10.1038/s41562-026-02454-z. Online ahead of print. | |
| 38224742 | Derived |
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De-identified data will be shared on the National Institute of Mental Health Data Archive as required by the National Institute of Health.
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The data will be available at the end of the study, five years from now.
The de-identified data will be shared on the National Institute of Mental Health Data Archive and will only be available to other researchers who have access to this platform.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | baseline, 6 weeks, 6 months, and 2 years |
|
Adverse event data were collected for 6 months following the baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Wilfley | Washington University in St. Louis School of Medicine | 3142862079 | wilfleyd@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2022 | Feb 11, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
Not provided
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| OTHER |
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|
| 6 weeks, 6 months, and 2 years |
| 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. | baseline, 6 weeks, 6 months, and 2 years |
| 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. | baseline, 6 months, and 2 years |
Behavioral activation will be measured using the Behavioral Activation for Depression Scale Short-Form. |
| baseline, 6 weeks, 6 months, 2 years |
| 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. | baseline, 6 weeks, 6 months, 2 years |
| 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. | baseline, 6 weeks, 6 months, 2 years |
| 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. | baseline, 6 weeks, 6 months, 2 years |
| 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. | baseline, 6 weeks, 6 months, 2 years |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Pennsylvania State University | State College | Pennsylvania | 16802 | United States |
| Basterfield C, Fitzsimmons-Craft EE, Taylor CB, Eisenberg D, Wilfley DE, Newman MG. Internalizing psychopathology and its links to suicidal ideation, dysfunctional attitudes, and help-seeking readiness in a national sample of college students. J Affect Disord. 2024 Apr 1;350:255-263. doi: 10.1016/j.jad.2024.01.058. Epub 2024 Jan 13. |
| 34049053 | Derived | Grammer AC, Vazquez MM, Fitzsimmons-Craft EE, Fowler LA, Rackoff GN, Schvey NA, Lipson SK, Newman MG, Eisenberg D, Taylor CB, Wilfley DE. Characterizing eating disorder diagnosis and related outcomes by sexual orientation and gender identity in a national sample of college students. Eat Behav. 2021 Aug;42:101528. doi: 10.1016/j.eatbeh.2021.101528. Epub 2021 May 15. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Diagnosis | We assessed mental health diagnosis with brief validated measures. GAD-Q-IV for general anxiety. High risk score greater or equal to 5.7. Clinical: diagnostic criteria SPDQ for social anxiety. High risk score of 7.4+. Clinical: diagnostic criteria PDSR for panic disorder. High risk score of 8.8. Clinical: diagnostic criteria PHQ-9 for depression. High risk score of 5-9. Clinical score 10+ SWED and WCS for eating disorders based on the last 3 months. High risk: weight concern score of 47+ and at least 1 purging episode. Clinical: 6 or more episode of binge eating or purging | Count of Participants | 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. |
| OG001 | 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. |
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | 6 weeks, 6 months, and 2 years |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks, 6 months, and 2 years |
|
|
|
|
| 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. | Analysis we ran separately for the mental component summary (MCS) and the physical component summary (PCS). | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 months, and 2 years |
|
|
|
|
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 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. | Not Posted | baseline, 6 weeks, 6 months, 2 years | Participants |
| 0 |
| 3,103 |
| 0 |
| 3,103 |
| 0 |
| 3,103 |
| EG001 | 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. | 0 | 3,102 | 0 | 3,102 | 0 | 3,102 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 2 year follow-up |
|
|
| Chi-squared |
| .000 |
| Odds Ratio (OR) |
| 1.83 |
| 2-Sided |
| 95 |
| 1.64 |
| 2.04 |
| Superiority |
| PHQ-9 6-month |
|
| PHQ-9 2-year |
|
| GADQ-IV Baseline |
|
| GADQ-IV 6-week |
|
| GADQ-IV 6-month |
|
| GADQ-IV 2-year |
|
| SPDQ Baseline |
|
| SPDQ 6-week |
|
| SPDQ 6-month |
|
| SPDQ 2-year |
|
| PDSR Baseline |
|
| PDSR 6-week |
|
| PDSR 6-month |
|
| PDSR 2-year |
|
| EDE-Q-Global Baseline |
|
| EDE-Q-Global 6-week |
|
| EDE-Q-Global 6-month |
|
| EDE-Q-Global 2-year |
|
| multilevel modeling methods |
Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. |
| .000 |
| Superiority |
| PHQ-9 2 year | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .02 | Superiority |
| GADQ-IV 6 week | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .002 | Superiority |
| GADQ-IV 6 month | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .80 | Superiority |
| GADQ-IV 2 year | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .51 | Superiority |
| SPDQ 6 week | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .004 | Superiority |
| SPDQ 6 month | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .02 | Superiority |
| SPDQ 2 year | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .09 | Superiority |
| PDSR 6 week | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .66 | Superiority |
| PDSR 6 month | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .85 | Superiority |
| PDSR 2 year | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .97 | Superiority |
| EDE-Q Global 6 week | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .000 | Superiority |
| EDE-Q Global 6 month | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .000 | Superiority |
| EDE-Q Global 2 year | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .54 | Superiority |
| MCS 2 years |
|
| PCS Baseline |
|
| PCS 6 months |
|
| PCS 2 years |
|
| multilevel modeling methods |
Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. |
| .04 |
| Superiority |
| Physical component summary 6 months | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .97 | Superiority |
| Physical component summary 2 years | multilevel modeling methods | Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions. | .80 | Superiority |