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Behavioural Intervention
SilverCloud Health Mobile Intervention + Social Networking Intervention for Anorexia Nervosa
N/A
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 9 months
Awards & highlights
Study Summary
This trial will help individuals with anorexia nervosa by developing and testing a mobile app with coaching and a social networking component.
Who is the study for?
This trial is for cisgender women over 18 with anorexia nervosa who have recently finished intensive treatment. Participants must own a mobile phone, speak English, live in the U.S., and have a BMI of at least 17.Check my eligibility
What is being tested?
The study is testing a new mobile app designed to support individuals recovering from anorexia. It includes coaching and social networking features to help manage their condition after leaving intensive care.See study design
What are the potential side effects?
Since this trial involves digital interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological discomfort while engaging with the app's content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months and 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1. 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.
Secondary outcome measures
Effectiveness of the mobile app conditions, compared to referral to usual care, in changing Body Mass Index (BMI).
Effectiveness of the mobile app conditions, compared to referral to usual care, in changing clinical impairment, as assessed by the Clinical Impairment Assessment.
Effectiveness of the mobile app conditions, compared to referral to usual care, in changing depression and suicidal ideation, as assessed by the Patient Health Questionnaire.
+1 moreOther outcome measures
Effectiveness of the mobile app conditions, compared to referral to usual care, in terms of achieving full recovery, as assessed with BMI, the Stanford-Washington University Eating Disorders Screen, and the EDE-Q.
Effectiveness of the mobile app conditions, compared to referral to usual care, in terms of reducing rehospitalization.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Coached Intervention Plus Social NetworkingExperimental Treatment2 Interventions
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.
Group II: Mobile Coached InterventionExperimental Treatment1 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.
Group III: Treatment as UsualActive Control1 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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,720 Total Patients Enrolled
2 Trials studying Anorexia Nervosa
284 Patients Enrolled for Anorexia Nervosa
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,677 Total Patients Enrolled
47 Trials studying Anorexia Nervosa
22,753 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was discharged from intensive treatment for anorexia nervosa within the last 2 months.I am a cisgender woman aged 18 or older.I do not identify as a cisgender woman.I am under 18 years old.I am a cisgender woman, 18+, with a BMI ≥ 17, own a mobile phone, speak English, live in the U.S., and was discharged from intensive anorexia treatment within 2 months.I have not been in intensive treatment for anorexia nervosa in the last 2 months.You have a body mass index (BMI) of 17 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile Coached Intervention
- Group 2: Mobile Coached Intervention Plus Social Networking
- Group 3: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this clinical exploration?
"According to clinicaltrials.gov, this study is open for enrollment at the moment and was first uploaded on December 1st 2022 with its most recent edits being made that same day."
Answered by AI
How many individuals have signed up to be part of this clinical investigation?
"Affirmative. The information found on clinicaltrials.gov attests that this medical trial is now seeking participants, as of December 1st 2022. Participants will be enrolled from 3 different locations and the total recruitment goal is 90 patients."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
California
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
Columbia University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How often would I need to travel to NYC?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Compensation for my condition. I've struggled to find a program that will help. I'm hoping something new and innovative will be the answer.
PatientReceived 2+ prior treatments
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