What is the mechanism of action of this treatment?

The most common treatments for Anorexia Nervosa, particularly those involving social support and coaching, focus on cognitive-behavioral therapy (CBT) and other psychological interventions. These treatments work by helping patients understand and change their distorted thoughts about body image and food, develop healthier eating patterns, and improve their emotional regulation. Social support and coaching provide continuous encouragement, motivation, and practical advice, which are crucial for maintaining progress and preventing relapse. This approach is important for Anorexia Nervosa patients as it addresses both the psychological and behavioral aspects of the disorder, promoting long-term recovery and improving overall well-being.

What side effects are associated with this type of intervention?

Common treatments for Anorexia Nervosa, such as Cognitive Behavioral Therapy (CBT), family-based therapy, and nutritional counseling, generally have minimal physical side effects. However, patients may experience emotional distress as they confront and work through their eating behaviors and underlying psychological issues. Social support and coaching can sometimes lead to dependency on the coach or support group, and there may be challenges in maintaining progress without ongoing support. Overall, these treatments are considered safe and are well-tolerated by most patients.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of Anorexia Nervosa. Treatment typically involves a multidisciplinary approach including nutritional rehabilitation, psychotherapy, and medical monitoring. Cognitive-behavioral therapy (CBT) is commonly used, and emerging treatments like the Coached Mobile App focus on providing social support and coaching to aid recovery. These digital interventions aim to complement traditional therapies by offering continuous support and motivation.

What other types of research exist?

Promising alternatives to a coached mobile app for anorexia nervosa patients include: 1) Smartphone-assisted behavioral interventions, which have shown efficacy in weight control and eating disorders. 2) Digital health programs using mobile applications, wireless scales, and nutritional programs without face-to-face care, which have been effective in large-scale weight loss. 3) Wearable technology combined with smartphone apps, which have improved engagement and outcomes in binge-eating disorders. These alternatives leverage technology to provide support and monitoring, potentially enhancing treatment adherence and outcomes.

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Behavioural Intervention

SilverCloud Health Mobile Intervention + Social Networking Intervention for Anorexia Nervosa

N/A

Waitlist Available

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

Summary

This trial is testing a mobile app designed to help people recovering from anorexia nervosa. The app uses therapy techniques to change negative thoughts and behaviors, and includes coaching and social support features to prevent relapse.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Other study objectives

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anorexia Nervosa, particularly those involving social support and coaching, focus on cognitive-behavioral therapy (CBT) and other psychological interventions. These treatments work by helping patients understand and change their distorted thoughts about body image and food, develop healthier eating patterns, and improve their emotional regulation. Social support and coaching provide continuous encouragement, motivation, and practical advice, which are crucial for maintaining progress and preventing relapse. This approach is important for Anorexia Nervosa patients as it addresses both the psychological and behavioral aspects of the disorder, promoting long-term recovery and improving overall well-being.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,970 Previous Clinical Trials

2,308,533 Total Patients Enrolled

2 Trials studying Anorexia Nervosa

284 Patients Enrolled for Anorexia Nervosa

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,446 Total Patients Enrolled

47 Trials studying Anorexia Nervosa

22,753 Patients Enrolled for Anorexia Nervosa

Media Library

SilverCloud Health Mobile Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05499676 — N/A

Anorexia Nervosa Research Study Groups: Mobile Coached Intervention, Mobile Coached Intervention Plus Social Networking, Treatment as Usual

Anorexia Nervosa Clinical Trial 2023: SilverCloud Health Mobile Intervention Highlights & Side Effects. Trial Name: NCT05499676 — N/A

SilverCloud Health Mobile Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499676 — N/A

~7 spots leftby Dec 2024

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