Trial Outcomes & Findings for Helping HAND: Healing Anorexia Nervosa Digitally (NCT NCT05499676)
NCT ID: NCT05499676
Last Updated: 2026-05-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
baseline, 6 weeks, 6 months, and 9 months
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
Completed 6 Week Follow Up Assessment
|
29
|
26
|
28
|
|
Overall Study
Completed 6 Month Follow Up Assessment
|
28
|
21
|
24
|
|
Overall Study
Completed 9 Month Follow Up Assessment
|
27
|
22
|
25
|
|
Overall Study
COMPLETED
|
30
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Differences in response rates across groups.
Baseline characteristics by cohort
| Measure |
Mobile Coached Intervention
n=30 Participants
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.
|
Total
n=90 Participants
Total of all reporting groups
|
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
|---|---|---|---|---|
|
Age, Continuous
|
25 Years
n=30 Participants
|
26.3 Years
n=90 Participants
|
27.5 Years
n=30 Participants
|
26.5 Years
n=30 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
2 Participants
n=30 Participants • Differences in response rates across groups.
|
3 Participants
n=89 Participants • Differences in response rates across groups.
|
1 Participants
n=30 Participants • Differences in response rates across groups.
|
0 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=30 Participants • Differences in response rates across groups.
|
1 Participants
n=89 Participants • Differences in response rates across groups.
|
0 Participants
n=30 Participants • Differences in response rates across groups.
|
1 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Race · Multiracial/Biracial
|
2 Participants
n=30 Participants • Differences in response rates across groups.
|
3 Participants
n=89 Participants • Differences in response rates across groups.
|
1 Participants
n=30 Participants • Differences in response rates across groups.
|
0 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Race · White
|
24 Participants
n=30 Participants • Differences in response rates across groups.
|
78 Participants
n=89 Participants • Differences in response rates across groups.
|
28 Participants
n=30 Participants • Differences in response rates across groups.
|
26 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Race · Multiple
|
2 Participants
n=30 Participants • Differences in response rates across groups.
|
4 Participants
n=89 Participants • Differences in response rates across groups.
|
0 Participants
n=30 Participants • Differences in response rates across groups.
|
2 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Ethnicity · Latina
|
5 Participants
n=30 Participants • Differences in response rates across groups.
|
7 Participants
n=89 Participants • Differences in response rates across groups.
|
0 Participants
n=30 Participants • Differences in response rates across groups.
|
2 Participants
n=29 Participants • Differences in response rates across groups.
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Latina
|
25 Participants
n=30 Participants • Differences in response rates across groups.
|
82 Participants
n=89 Participants • Differences in response rates across groups.
|
30 Participants
n=30 Participants • Differences in response rates across groups.
|
27 Participants
n=29 Participants • Differences in response rates across groups.
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
Mobile Coached Intervention
n=30 Participants
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.
|
|---|---|---|---|
|
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.
Baseline Assessment
|
3.83 Scores on a scale
Standard Deviation 1.03
|
3.57 Scores on a scale
Standard Deviation 1.50
|
3.52 Scores on a scale
Standard Deviation 1.16
|
|
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.
9 Month Follow Up Assessment
|
3.27 Scores on a scale
Standard Deviation 1.20
|
3.25 Scores on a scale
Standard Deviation 1.72
|
3.08 Scores on a scale
Standard Deviation 1.54
|
|
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.
6 Week Follow Up Assessment
|
3.42 Scores on a scale
Standard Deviation 1.11
|
3.20 Scores on a scale
Standard Deviation 1.57
|
3.44 Scores on a scale
Standard Deviation 1.49
|
|
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.
6 Month Follow Up Assessment
|
3.49 Scores on a scale
Standard Deviation 1.35
|
3.46 Scores on a scale
Standard Deviation 1.72
|
3.18 Scores on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
Mobile Coached Intervention
n=30 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 6 Month Assessment · Report any binge eating on EDE-Q
|
16 Participants
|
16 Participants
|
16 Participants
|
|
Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 9 Month Assessment · Report any binge eating on EDE-Q
|
20 Participants
|
16 Participants
|
19 Participants
|
|
Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Reported Any Eating Disorder Behaviors on EDE-Q at Baseline Assessment · Report any binge eating on EDE-Q
|
23 Participants
|
22 Participants
|
23 Participants
|
|
Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.
Number of Participants who Reported Any Eating Disorder Behaviors on EDE-Q at 6 Week Assessment · Report any binge eating on EDE-Q
|
18 Participants
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
Mobile Coached Intervention
n=30 Participants
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.
|
|---|---|---|---|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
Baseline Assessment
|
21.0 kg/m^2
Interval 18.5 to 26.1
|
22.4 kg/m^2
Interval 20.1 to 26.7
|
22.5 kg/m^2
Interval 20.2 to 25.1
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
6 Week Assessment
|
20.7 kg/m^2
Interval 18.3 to 25.2
|
21.6 kg/m^2
Interval 18.9 to 27.2
|
22.9 kg/m^2
Interval 20.8 to 25.8
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
9 Month Assessment
|
21.4 kg/m^2
Interval 18.7 to 29.1
|
22.9 kg/m^2
Interval 20.2 to 26.5
|
20.5 kg/m^2
Interval 19.0 to 26.8
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).
6 Month Assessment
|
20.9 kg/m^2
Interval 18.9 to 27.3
|
22.5 kg/m^2
Interval 18.8 to 26.4
|
21.0 kg/m^2
Interval 19.7 to 27.3
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
Mobile Coached Intervention
n=30 Participants
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.
|
|---|---|---|---|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
6 Week Assessment
|
11.31 Scores on a scale
Standard Deviation 6.43
|
10.81 Scores on a scale
Standard Deviation 7.24
|
11.46 Scores on a scale
Standard Deviation 7.01
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
6 Month Assessment
|
11 Scores on a scale
Standard Deviation 6.8
|
9.86 Scores on a scale
Standard Deviation 7.62
|
11.04 Scores on a scale
Standard Deviation 8.25
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
Baseline Assessment
|
11.3 Scores on a scale
Standard Deviation 6.59
|
12.87 Scores on a scale
Standard Deviation 7.35
|
10.33 Scores on a scale
Standard Deviation 5.63
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.
9 Month Assessment
|
10.96 Scores on a scale
Standard Deviation 7.18
|
11.41 Scores on a scale
Standard Deviation 8.23
|
12.12 Scores on a scale
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 6 months, and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=30 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.
|
Mobile Coached Intervention Plus Social Networking
n=30 Participants
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.
|
Mobile Coached Intervention
n=30 Participants
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.
|
|---|---|---|---|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
Baseline Assessment
|
28.07 Scores on a scale
Standard Deviation 9.67
|
28.97 Scores on a scale
Standard Deviation 13.43
|
27.03 Scores on a scale
Standard Deviation 9.55
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
6 Week Assessment
|
25.65 Scores on a scale
Standard Deviation 11.68
|
24.88 Scores on a scale
Standard Deviation 13.82
|
27.04 Scores on a scale
Standard Deviation 11.07
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
6 Month Assessment
|
23.71 Scores on a scale
Standard Deviation 12.31
|
24.72 Scores on a scale
Standard Deviation 13.98
|
24.06 Scores on a scale
Standard Deviation 13.69
|
|
Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.
9 Month Assessment
|
23.82 Scores on a scale
Standard Deviation 12.1
|
25.59 Scores on a scale
Standard Deviation 14.54
|
26.68 Scores on a scale
Standard Deviation 13.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=28 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.
|
Mobile Coached Intervention Plus Social Networking
n=22 Participants
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.
|
Mobile Coached Intervention
n=25 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care.
Number of Participants who Didn't Report Hospitalization for ED from Baseline to 6 Month Assessment
|
25 Participants
|
21 Participants
|
21 Participants
|
|
Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care.
Number of Participants who Didn't Report Hospitalization for ED from Baseline to 9 Month Assessment
|
23 Participants
|
21 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=27 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.
|
Mobile Coached Intervention Plus Social Networking
n=21 Participants
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.
|
Mobile Coached Intervention
n=24 Participants
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.
|
|---|---|---|---|
|
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.
Number of Participants who Achieved Full Recovery at 6 Month Assessment
|
2 Participants
|
2 Participants
|
4 Participants
|
|
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.
Number of Participants who Achieved Full Recovery at 9 Month Assessment
|
2 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile Coached Intervention Plus Social Networking
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Mobile Coached Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment as Usual
n=30 participants at risk
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.
|
Mobile Coached Intervention Plus Social Networking
n=30 participants at risk
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.
|
Mobile Coached Intervention
n=30 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Participant death while enrolled
|
0.00%
0/30 • From enrollment until end of follow-up, up to 9 months
|
3.3%
1/30 • From enrollment until end of follow-up, up to 9 months
|
0.00%
0/30 • From enrollment until end of follow-up, up to 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Ellen Fitzsimmons-Craft
Washington University in St. Louis
Phone: 3143413238
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place