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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH127203 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period
Anorexia nervosa (AN) is a costly and life-threatening illness. Patients with severe AN are often treated in the acute setting, but relapse after treatment is common. Further, the discharge criterion in acute settings is typically weight restoration. However, research has indicated that weight-based recovery is not "enough" and that full recovery involves physical, behavioral, and psychological components. Cognitive-behavioral therapy (CBT) is useful with this population, including following discharge, and may aid in addressing psychological symptoms, achieving full recovery, and decreasing relapse. However, very few patients have access to providers trained in these techniques. mHealth technologies have great potential to exponentially increase access to high-quality services for the post-acute treatment of AN by addressing barriers to treatment, but to date, research on these approaches has been extremely limited. A guided self-help CBT-based mobile app, StudentBodies-Eating Disorders (SB-ED), has been successfully developed, demonstrating effectiveness among college women with binge/purge-type EDs. At the same time, there is demonstrated support for in-person CBT for the post-acute care and relapse prevention of adult AN. The overarching goal of this R34 is thus to develop and test a CBT-based, coached mobile app to address the post-acute care and relapse prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Coached Intervention | Experimental | Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. |
|
| Mobile Coached Intervention Plus Social Networking | Experimental | Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. |
|
| Treatment as Usual | No Intervention | This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD ) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SilverCloud Health Mobile Intervention | Device | SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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 App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire. | Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. The main outcome variable will be the EDE-Q Global score, an overall measure of eating disorder psychopathology. Scores possible range from 0 to 6, with higher scores indicating greater eating disorder psychopathology. | baseline, 6 weeks, 6 months, and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care. | Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. For this secondary outcome, investigators will examine eating disorder behavior frequencies from the EDE-Q. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care. | To assess rehospitalization and other treatment utilization, investigators will use a detailed treatment history questionnaire. Rehospitalization rates will be compared across conditions at 6 months and 9 months. | 6 months and 9 months |
Inclusion Criteria:
Exclusion Criteria:
Cisgender women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto University | Palo Alto | California | 94304 | United States | ||
| Washington University School of Medicine |
De-identified data will not be shared on the National Institute of Mental Health Data Archive, as this is a pilot study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers. |
| FG001 | Mobile Coached Intervention Plus Social Networking | Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. Facebook: Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group. |
| FG002 | Mobile Coached Intervention | Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers. |
| 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 App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire. | Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. The main outcome variable will be the EDE-Q Global score, an overall measure of eating disorder psychopathology. Scores possible range from 0 to 6, with higher scores indicating greater eating disorder psychopathology. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 6 weeks, 6 months, and 9 months |
|
From enrollment until end of follow-up, up to 9 months
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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 | Treatment as Usual | This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant death while enrolled | General disorders | Non-systematic Assessment | A participant who struggled with anorexia for 11 years passed away while in the study. A loved one notified the study team when the participant was placed on hospice and passed. There is no evidence the event was related to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Fitzsimmons-Craft | Washington University in St. Louis | 3143413238 | fitzsimmonse@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 | Jun 15, 2023 | Feb 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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|
| Social Networking Intervention: Facebook | Device | Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group |
|
| baseline, 6 weeks, 6 months, and 9 months |
| Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI). | Investigators will use current BMI as derived from self-reported height, which has shown to be accurate in adult ED populations, and weight assessed by a digital wireless scale. At each of the study timepoints, a study coordinator will schedule a time with the participant to take their weight while they are on a Zoom call with the coordinator. Participants will be instructed to take off their shoes, wear light clothing, and empty their pockets, similar to the instructions that would be provided if this measurement were being taken in person. Given the use of a wireless scale, the measurement will be able to be immediately and automatically sent to the research team. | baseline, 6 weeks, 6 months, and 9 months |
| Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire. | Investigators will use the Patient Health Questionnaire (PHQ-9), a 9-item measure that is widely used to assess presence of possible depression and severity. Scores possible range from 0 to 27, with higher scores indicating greater severity of depression. | baseline, 6 weeks, 6 months, and 9 months |
| Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment. | Investigators will use the Clinical Impairment Assessment (CIA), which is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features. Scores range from 0 to 48 with higher scores indicating higher levels of impairment. | baseline, 6 weeks, 6 months, and 9 months |
| Number of Participants Who Achieved Full Recovery in the Mobile App Conditions Compared to Referral to Usual Care, as Assessed With BMI, the Stanford-Washington University Eating Disorders Screen, and EDE-Q. | For recovery, at 6- and 9-month assessments, investigators will compare the percent of participants across study conditions who have achieved full recovery from an eating disorder, comprised of: 1) physical recovery based on having a BMI ≥ 18.5 kg/m2; 2) behavioral recovery based on absence of binge eating, vomiting, laxative use, and fasting in the past 3 months (assessed via the Stanford-Washington University Eating Disorder Screen); and 3) cognitive recovery based on scoring within 1 SD of community norms for each of the EDE-Q subscales. | 6 months and 9 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| BG001 | Mobile Coached Intervention Plus Social Networking | Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. Facebook: Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group. |
| BG002 | Mobile Coached Intervention | Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Differences in response rates across groups. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Differences in response rates across groups. | Count of Participants | Participants |
|
This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers.
| OG001 | Mobile Coached Intervention Plus Social Networking | Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. Facebook: Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group. |
| OG002 | Mobile Coached Intervention | Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. |
|
|
|
| Secondary | Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care. | Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. For this secondary outcome, investigators will examine eating disorder behavior frequencies from the EDE-Q. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Count of Participants | Participants | baseline, 6 weeks, 6 months, and 9 months |
|
|
|
|
| Secondary | Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI). | Investigators will use current BMI as derived from self-reported height, which has shown to be accurate in adult ED populations, and weight assessed by a digital wireless scale. At each of the study timepoints, a study coordinator will schedule a time with the participant to take their weight while they are on a Zoom call with the coordinator. Participants will be instructed to take off their shoes, wear light clothing, and empty their pockets, similar to the instructions that would be provided if this measurement were being taken in person. Given the use of a wireless scale, the measurement will be able to be immediately and automatically sent to the research team. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Mean | Full Range | kg/m^2 | baseline, 6 weeks, 6 months, and 9 months |
|
|
|
|
| Secondary | Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire. | Investigators will use the Patient Health Questionnaire (PHQ-9), a 9-item measure that is widely used to assess presence of possible depression and severity. Scores possible range from 0 to 27, with higher scores indicating greater severity of depression. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 6 weeks, 6 months, and 9 months |
|
|
|
|
| Secondary | Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment. | Investigators will use the Clinical Impairment Assessment (CIA), which is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features. Scores range from 0 to 48 with higher scores indicating higher levels of impairment. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 6 weeks, 6 months, and 9 months |
|
|
|
|
| Other Pre-specified | Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care. | To assess rehospitalization and other treatment utilization, investigators will use a detailed treatment history questionnaire. Rehospitalization rates will be compared across conditions at 6 months and 9 months. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Count of Participants | Participants | 6 months and 9 months |
|
|
|
|
| Other Pre-specified | Number of Participants Who Achieved Full Recovery in the Mobile App Conditions Compared to Referral to Usual Care, as Assessed With BMI, the Stanford-Washington University Eating Disorders Screen, and EDE-Q. | For recovery, at 6- and 9-month assessments, investigators will compare the percent of participants across study conditions who have achieved full recovery from an eating disorder, comprised of: 1) physical recovery based on having a BMI ≥ 18.5 kg/m2; 2) behavioral recovery based on absence of binge eating, vomiting, laxative use, and fasting in the past 3 months (assessed via the Stanford-Washington University Eating Disorder Screen); and 3) cognitive recovery based on scoring within 1 SD of community norms for each of the EDE-Q subscales. | Differences in the analysis population reflect incomplete assessment and measure completion over time. Analyses were conducted using all available data for each measure at each time point. | Posted | Count of Participants | Participants | 6 months and 9 months |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Mobile Coached Intervention Plus Social Networking | Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. Facebook: Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group. | 1 | 30 | 1 | 30 | 0 | 30 |
| EG002 | Mobile Coached Intervention | Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. SilverCloud: SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. 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. | 0 | 30 | 0 | 30 | 0 | 30 |
|
Not provided
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| Male |
|
| Black or African American |
|
| Multiracial/Biracial |
|
| White |
|
| Multiple |
|
| Non-Latina |
|
| Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 6 Week Assessment |
|
|
| Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 6 Month Assessment |
|
|
| Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 9 Month Assessment |
|
|
Logistic regression model to determine if there are changes over time (from baseline to 9-month assessment) in abstinence from all eating disorder behaviors (as measured by EDE-Q) in the mobile coached intervention group compared to the treatment as usual group. |
| Regression, Logistic |
| 0.875 |
| Odds Ratio (OR) |
| 0.76 |
| 2-Sided |
| 95 |
| 0.24 |
| 2.44 |
| Other |
| Logistic regression model to determine if there are changes over time (from baseline to 9-month assessment) in abstinence from all eating disorder behaviors (as measured by EDE-Q) in the mobile coached intervention plus social networking group compared to the treatment as usual group. | Regression, Logistic | 0.875 | Odds Ratio (OR) | 0.99 | 2-Sided | 95 | 0.31 | 3.19 | Other |
| 6 Week Assessment |
|
|
| 6 Month Assessment |
|
|
| 9 Month Assessment |
|
|
| Mixed Models Analysis |
| 0.2959 |
| Mean Difference (Net) |
| -1.03 |
| 2-Sided |
| 95 |
| -2.96 |
| 0.91 |
| Other |
| Multilevel model for % change in body mass index over time from baseline to the 9-month assessment in the mobile coached intervention plus social networking group. | Mixed Models Analysis | 0.4934 | Mean Difference (Net) | -0.72 | 2-Sided | 95 | -2.77 | 1.34 | Other |
| This multilevel model examined % change in BMI from baseline through the 9-month assessment and tested for overall between-group differences across time to determine if any one treatment arm was more effective than the others. | Mixed Models Analysis | .029 | Superiority |
| 6 Week Assessment |
|
|
| 6 Month Assessment |
|
|
| 9 Month Assessment |
|
|
| Mixed Models Analysis |
| 0.4287 |
| Mean Difference (Net) |
| 0.46 |
| 2-Sided |
| 95 |
| -0.69 |
| 1.61 |
| Other |
| Multilevel model for change over time (from baseline to 9 month assessment) in PHQ-9 score in the mobile coached intervention plus social networking group. | Mixed Models Analysis | 0.0281 | Mean Difference (Net) | -1.36 | 2-Sided | 95 | -2.58 | -0.15 | Other |
| This multilevel model examined change in PHQ-9 scores from baseline through the 9-month assessment and tested for overall between-group differences across time to determine if any one treatment arm was more effective than the others. | Mixed Models Analysis | 0.101 | Superiority |
| 6 Week Assessment |
|
|
| 6 Month Assessment |
|
|
| 9 Month Assessment |
|
|
| 0.0882 |
| Mean Difference (Net) |
| -1.97 |
| 2-Sided |
| 95 |
| -4.23 |
| 0.3 |
| Other |
Multilevel model for change over time (from baseline to 9 month assessment) in CIA score. |
| Mixed Models Analysis | 0.0013 | Mean Difference (Net) | -3.96 | 2-Sided | 95 | -6.35 | -1.56 | Other | Multilevel model for change over time (from baseline to 9 month assessment) in CIA score. |
| This multilevel model examined change in CIA scores from baseline through the 9-month assessment and tested for overall between-group differences across time to determine if any one treatment arm was more effective than the others. | Mixed Models Analysis | 0.390 | Superiority |
| Number of Participants who Didn't Report Hospitalization for ED from Baseline to 9 Month Assessment |
|
|
| Fisher Exact |
| 0.4472 |
| Superiority |
| Number of Participants who Achieved Full Recovery at 9 Month Assessment |
|
|
| Fisher Exact |
| 0.882 |
| Superiority |