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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ED-TREAT, a new tool in electronic health records that helps doctors in emergency rooms manage patient behavior. It focuses on patients at risk of becoming agitated and uses data to guide doctors in preventing agitation. The study aims to see if this tool can improve care quality and resource use.

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 data supports the effectiveness of the ED-TREAT treatment for eating disorders?

The research on a day patient program for eating disorders showed that participants improved in key areas like eating habits and quality of life, and these improvements were maintained or even enhanced three months after treatment. This suggests that structured treatment programs can be effective for eating disorders. ^{1 2 3 4 5}

Is ED-TREAT safe for humans?

The safety of treatments for eating disorders often involves medications like fluoxetine and lisdexamfetamine, which are generally considered safe for conditions like bulimia nervosa and binge eating disorder. However, specific safety data for ED-TREAT itself is not available in the provided research. ^{6 7 8 9 10}

How is the ED-TREAT treatment for eating disorders different from other treatments?

ED-TREAT may offer a unique approach by potentially combining elements like training of eating behavior, satiety, and social activity restoration, which have shown high remission rates in other studies, unlike traditional treatments that often rely heavily on medications like antidepressants with limited effectiveness. ^{6 8 11 12 13}

Research Team

Ambrose H. Wong, [phone]

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An evaluation of the effectiveness and short-term stability of an innovative Australian day patient programme for eating disorders. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Trans-diagnostic outcome of eating disorders: A 30-month follow-up study of 629 patients. [2015]

3. England pubmed.ncbi.nlm.nih.gov

The impact of different outcome measures on estimates of remission in a 3-year follow-up of eating disorders. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Does level of motivation for change impact post-treatment outcomes in the eating disorders? Protocol for a systematic review with quantitative analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Classifying empirically valid and clinically meaningful change in eating disorders using the Eating Disorders Inventory, version 2 (EDI-2). [2018]

6. England pubmed.ncbi.nlm.nih.gov

World Federation of Societies of Biological Psychiatry (WFSBP) guidelines update 2023 on the pharmacological treatment of eating disorders. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of eating disorders, comorbid mental health problems, malnutrition and physical health consequences. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Biological therapies for eating disorders. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Media Smart-Targeted: Diagnostic outcomes from a two-country pragmatic online eating disorder risk reduction trial for young adults. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Psychotropic drug prescribing in an Australian specialist child and adolescent eating disorder service: a retrospective study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of eating disorders. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

What is the evidence basis for existing treatments of eating disorders? [2019]

13. England pubmed.ncbi.nlm.nih.gov

Effectiveness of enhanced cognitive behavioral therapy (CBT-E) for eating disorders: study protocol for a randomized controlled trial. [2018]