SilverCloud Health Mobile Intervention + Social Networking Intervention for Anorexia Nervosa

No longer recruiting at 4 trial locations

Overseen By Denise Wilfley

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-cisgender, Under 18, BMI below 17, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app, the SilverCloud Health Mobile Intervention, designed to support individuals with anorexia nervosa after intensive treatment. The app provides coach support and a social networking feature for six months. Participants may use the app with or without the social networking component while continuing their usual care plans. This trial suits cisgender women in the U.S. who have recently completed intensive treatment for anorexia nervosa and have a BMI of 17 or higher. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve recovery support for others in the future.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile intervention and social networking intervention are safe for individuals with anorexia nervosa?

Research shows that the SilverCloud Health Mobile Intervention, designed for individuals with anorexia nervosa, is safe and easy to use. Studies have examined cognitive-behavioral therapy (CBT) delivered through this mobile app, and results suggest that users find it practical and acceptable. Users generally manage the app well, with no major safety issues reported.

The social networking component uses platforms like Facebook to support recovery. While social media has its pros and cons, studies have explored Facebook use among those treated for eating disorders. These studies indicate that, when used carefully, social networking can safely foster supportive communities.

In summary, both the mobile app and social networking components appear to be safe options based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SilverCloud Health Mobile Intervention for anorexia nervosa because it offers a digital, easily accessible treatment option that can be used alongside traditional therapies. Unlike standard treatments that often rely on in-person therapy sessions and medication, this mobile app provides continuous support and guidance, making it more convenient for users to access help anytime, anywhere. The addition of a social networking component in one of the treatment arms also introduces a community support aspect, potentially enhancing engagement and motivation by connecting individuals with others facing similar challenges. These features make it a promising tool to complement existing care and potentially improve recovery outcomes.

What evidence suggests that this trial's treatments could be effective for anorexia nervosa?

Research shows that the SilverCloud Health Mobile Intervention uses cognitive-behavioral therapy (CBT) techniques to change negative thoughts and behaviors. In this trial, participants in the "Mobile Coached Intervention" arm will access this app for six months. One study found that this app, when combined with regular treatment, is practical and well-received by individuals recovering from anorexia nervosa.

Additionally, participants in the "Mobile Coached Intervention Plus Social Networking" arm will access both the mobile app and a Facebook social networking component. This offers support and a sense of community, crucial for recovery. People with eating disorders often use social media, like Facebook, to find support and connect with others who understand their experiences. While these features appear promising, more research is needed to confirm their effectiveness in treating anorexia nervosa. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

U.S. residents

Connected with a physician (such as a primary care provider)

I was discharged from intensive treatment for anorexia nervosa within the last 2 months.

Exclusion Criteria

Individuals who are not connected with a physician (such as a primary care provider)

Individuals who do not own a mobile phone

I do not identify as a cisgender woman.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to a CBT-based mobile app for post-acute care and relapse prevention for 6 months

6 months

Ongoing virtual support

Follow-up

Participants are monitored for changes in eating disorder psychopathology, BMI, depression, and clinical impairment

3 months

Assessments at 6 and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• SilverCloud Health Mobile Intervention
• Social Networking Intervention: Facebook

Trial Overview 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.

How Is the Trial Designed?

Group I: Mobile Coached Intervention Plus Social Networking Experimental Treatment 2 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 Intervention Experimental Treatment 1 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 Usual Active Control 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10019771/

A Pilot Randomized Controlled Trial of a Cognitive ... The aim of this study is to estimate the preliminary feasibility and effectiveness of a CBT-based mobile intervention plus treatment as usual (TAU).

2. withpower.com withpower.com/trial/phase-anorexia-9-2022-f01d8

SilverCloud Health Mobile Intervention + Social ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04162847?tab=history&a=5

Record History | ver. 5: 2022-07-11 | NCT04162847 The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1471015324000242

Development and usability testing of a cognitive-behavioral ... This study provides evidence of feasibility and acceptability of an app and social networking feature for post-acute care of AN.

5. withpower.com withpower.com/clinical-trials/for-anorexia-nervosa

Top Anorexia Nervosa Clinical Trials | Power 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 ...

6. aci.health.nsw.gov.au aci.health.nsw.gov.au/__data/assets/pdf_file/0019/935011/Evidence-Check-Digital-mental-health-young-people.pdf

Evidence-Check-Digital-mental-health-young-people. ... A data extraction table including intervention description, features and key outcomes were completed for systematic reviews (table 1). Many ...