ED-TREAT for Eating Disorders

Overseen By Jessica Ray, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Restraint orders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool called ED-TREAT to help manage eating disorders in emergency settings. The researchers aim to determine if healthcare providers find this tool practical and acceptable. Participants will receive either the ED-TREAT approach or usual care to compare effectiveness. The trial seeks adults visiting the emergency department who are at risk of agitation but do not require immediate physical restraint. Participants should feel comfortable speaking English and be able to give verbal consent. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emergency care for eating disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ED-TREAT is safe for use in eating disorder treatment?

Research has shown that ED-TREAT is a tool designed to help healthcare providers manage eating disorders by assessing risks and suggesting behavioral techniques. Although no direct study data exists on the safety of ED-TREAT, it is intended for decision-making in emergency situations, suggesting minimal direct risk to patients.

This trial is in the "Not Applicable" phase, likely indicating that it tests the tool's effectiveness in real-life settings rather than a new drug. This usually suggests no major safety concerns with the tool itself. Additionally, as a support tool rather than a medication, the risk of side effects is lower compared to drug treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ED-TREAT because it introduces an innovative approach to managing eating disorders in emergency settings. Unlike traditional treatments that rely heavily on psychotherapy or medication over time, ED-TREAT is an EHR-embedded clinical decision support tool. This tool is designed to help healthcare providers quickly assess risk and suggest pre-emptive behavioral techniques right when they're needed most. This immediate, tech-driven response could overcome existing challenges in emergency evaluations and interventions, potentially leading to faster and more effective care for patients experiencing acute symptoms of eating disorders.

What evidence suggests that this ED-TREAT tool is effective for eating disorders?

Research has shown that current treatments for eating disorders like anorexia nervosa and bulimia nervosa have mixed success. One study that tracked patients for six years found that about 52% of those with anorexia and 50% to 57% of those with bulimia recovered. Cognitive-behavioral therapy, often used for bulimia, has proven widely effective. However, traditional treatments often have limited success, with only 31% of anorexia patients recovering. In this trial, participants will receive either the ED-TREAT tool or usual care. ED-TREAT is designed to improve decision-making in emergency situations by using proactive behavioral techniques to address these issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Ambrose H. Wong, [phone]

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who might be at risk of psychomotor agitation or behavioral disorders. Participants should not need physical restraints upon arrival, must be alert and calm, speak English well enough to converse, and can verbally agree to join the study.

Inclusion Criteria

Able to provide verbal consent.

You are considered to be at risk of becoming agitated, as determined by ED-TREAT.

You have a score of "4" on a scale that measures how alert and active you are.

Exclusion Criteria

You are not under a physical restraint order within 30 minutes of arrival, unless it is for protecting medical equipment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are involved in the pilot trial testing the ED-TREAT tool compared to usual care

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ED-TREAT

Trial Overview The ED-TREAT approach is being tested against usual care methods to see if it's acceptable, can be followed as intended (fidelity), and works well in practice (feasibility) for early detection and treatment of agitation.

How Is the Trial Designed?

Group I: ED-TREAT Experimental Treatment 1 Intervention

EHR-embedded clinical decision support (CDS) tool designed to overcome the challenges to risk assessment and suggest pre-emptive use of behavioral techniques in the emergency setting.

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Media Smart-Targeted (MS-T) program significantly reduced the likelihood of eating disorder (ED) onset by 66% in young-adult women compared to a control group, although this result was not statistically significant.

For participants who already met ED criteria at the start of the study, the MS-T program led to a 75% reduction in the likelihood of still meeting diagnostic criteria at the 12-month follow-up, demonstrating its effectiveness as a treatment intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Media Smart-Targeted: Diagnostic outcomes from a two-country pragmatic online eating disorder risk reduction trial for young adults. Wilksch, SM., O'Shea, A., Wade, TD.[2018]

Antidepressants, especially SSRIs, are effective in reducing symptoms of bulimia nervosa, while various medications can help decrease binge eating frequency in binge eating disorder, though they have only modest effects on weight.

The treatment options for anorexia nervosa are limited, with few controlled trials showing disappointing results for atypical antipsychotics, highlighting the need for more research in pharmacological therapies for eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological therapies for eating disorders. Mitchell, JE., Roerig, J., Steffen, K.[2021]

In a study of 629 patients with various eating disorders over 30 months, 42% achieved full remission and 72% achieved partial remission, indicating significant recovery potential.

Adults with anorexia-like eating disorder not otherwise specified (EDNOS-AN) had the worst outcomes, while bingeing and purging behaviors were linked to poorer outcomes in bulimic disorders, highlighting the need for targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-diagnostic outcome of eating disorders: A 30-month follow-up study of 629 patients. Helverskov, JL., Clausen, L., Mors, O., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10228434/

Eating disorder outcomes: findings from a rapid review of over ... A 6 year study following the course of a large clinical sample (n = 793) reported overall recovery rates of 52% for AN, 50–52% for BN, 57% for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763422003463

Treatment of eating disorders: A systematic meta-review ... In adults with BN, individual cognitive behavioural therapy (CBT)-ED had the broadest efficacy versus active control; also, antidepressants outperformed active.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211111/

Recent Advances in Cognitive-Behavioural Therapy for Eating ... The key advances identified here include: improvements in the efficiency and availability of CBT-ED; expansion of applicability to younger cases ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2019.02985/full

Demographics and Outcomes of Patients With Eating ... Results showed weight gain in the patients with anorexia nervosa, decreased bingeing/purging in the patients with bulimia nervosa (BN), and ...

5. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01246-6

Treating the individual: moving towards personalised eating ... Poor to modest treatment outcomes with current manualised treatments (only 31% of people with Anorexia Nervosa and 68% of those with Bulimia ...

6. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10243293/

An overview of the treatment of eating disorders in adults and ... At the moment, the recommended psychotropic medication for eating disorders is represented by fluoxetine for bulimia nervosa and lisdexamfetamine for binge ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1471491424000340

Established and emerging treatments for eating disorders In this review article, we first outline the evidence-base for the established treatments of the three 'classical' EDs [anorexia nervosa (AN), bulimia nervosa ( ...

9. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00801-3

Eating disorder outcomes: findings from a rapid review of over ... Eating disorders (ED), especially Anorexia Nervosa (AN), are internationally reported to have amongst the highest mortality and suicide ...

10. hsph.harvard.edu hsph.harvard.edu/wp-content/uploads/2024/10/Social-Economic-Cost-of-Eating-Disorders-in-US.pdf

Social and economic cost of eating disorders in the United ... Available at: https://www.hsph.harvard.edu/striped/report-economic-costs-of-eating-disorders/. Page 3. Deloitte Access Economics is Australia's pre-eminent ...