320 Participants Needed

Personalized Treatment for Eating Disorders

(T-NIPT-ED Trial)

EC
CA
Overseen ByCheri A Levinson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.

Will I have to stop taking my current medications?

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.

Is Enhanced Cognitive Behavioral Therapy for Eating Disorders safe for humans?

The research does not provide specific safety data for Enhanced Cognitive Behavioral Therapy for Eating Disorders, but it is a widely studied and used treatment approach for eating disorders.12345

What makes the Transdiagnostic Network Informed Personalized Treatment for Eating Disorders unique compared to other treatments?

This treatment is unique because it uses a personalized approach based on individual symptom networks, which helps address the diverse ways eating disorders can present in different people, potentially improving treatment outcomes.12678

What data supports the effectiveness of the treatment Enhanced Cognitive Behavioral Therapy for Eating Disorders?

Recent studies suggest that Enhanced Cognitive Behavioral Therapy (CBT-E) is promising for treating eating disorders, including bulimia nervosa, by addressing fears related to food and body image. However, up to 44% of individuals with bulimia may experience worsening symptoms after standard CBT, indicating a need for personalized approaches like CBT-E.12369

Who Is on the Research Team?

CA

Cheri A Levinson, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with an active eating disorder, excluding ARFID. It's not suitable for individuals who are currently experiencing suicidal thoughts, mania, or psychosis.

Inclusion Criteria

I have an active eating disorder, but it's not ARFID.

Exclusion Criteria

Active Suicidality
Active Mania
Active psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Ecological Momentary Assessment

Participants undergo two weeks of ecological momentary assessment to characterize individual mechanisms of treatment

2 weeks
Virtual assessments

Phase II: Treatment

Participants receive 10 sessions of either Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E) or personalized treatment based on ecological momentary assessment surveys

10 weeks
10 sessions (virtual)

Relapse Prevention

Participants complete one session of relapse prevention at the end of the treatment phase

1 week
1 session (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Cognitive Behavioral Therapy for Eating Disorders
  • Transdiagnostic Network Informed Personalized Treatment
Trial Overview The study compares a new personalized treatment (T-NIPT-ED) using mobile technology and individual modeling to the standard Cognitive Behavioral Therapy Enhanced (CBT-E) in treating eating disorders.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdiagnostic Network Informed Personalized TreatmentExperimental Treatment1 Intervention
Participants will receive 1 session of education about the treatment after completing Phase I of the study (two weeks of ecological momentary assessment). Participants will then complete 10 sessions of personalized treatment for eating disorders based on their ecological momentary assessment surveys. Participants will complete one session of relapse prevention at the end.
Group II: Cognitive Behavioral Therapy for Eating DisordersActive Control1 Intervention
Participants will receive 1 session of education about the treatment after completing Phase I of the study (two weeks of ecological momentary assessment). Participants will then complete 10 sessions of Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E. Participants will complete one session of relapse prevention at the end.

Enhanced Cognitive Behavioral Therapy for Eating Disorders is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as CBT-E for:
  • Anorexia Nervosa
  • Bulimia Nervosa
  • Binge Eating Disorder
  • Other Specified Feeding or Eating Disorder
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as CBT-E for:
  • Anorexia Nervosa
  • Bulimia Nervosa
  • Binge Eating Disorder
  • Other Specified Feeding or Eating Disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT) both effectively influenced the relationships among symptoms of Binge-Eating Disorder (BED) in a study of 392 adults, indicating that both treatments can be beneficial.
The symptom of shape concern was identified as the most strongly interconnected and significantly predicted remission indicators, suggesting it could be a key target for future interventions in treating BED.
Examining changes in binge-eating disorder network centrality and structure in patients treated with cognitive-behavioral therapy versus interpersonal psychotherapy.Forrest, LN., Franko, DL., Thompson-Brenner, H., et al.[2023]
In a study of 122 patients with eating disorders, it was found that changes in cognitions about body shape are crucial for symptom improvement, with overvaluation of shape being a key predictor of other symptoms.
The analysis revealed different symptom change processes based on childhood maltreatment history, suggesting that tailored therapeutic approaches may be necessary for individuals with such backgrounds to reduce dropout and relapse rates.
Breaking the cycle: Identifying key symptom pathways of eating disorders and the influence of childhood maltreatment.Kopland, MCG., Vrabel, K., Slof-Op 't Landt, M., et al.[2023]
In a study of 143 individuals with eating disorders, imaginal exposure therapy showed promise in reducing fears related to weight gain and eating, which are central to ED symptoms.
The research identified that targeting fears of weight gain and the consequences of eating may lead to the most significant improvements in eating disorder pathology, suggesting these fears are optimal focus areas for therapy.
Eating Disorder Symptom and Fear Change Trajectories During Imaginal Exposure Therapy: A Slope Network Analysis.Nicholas, JK., Cusack, CE., Levinson, CA.[2023]

Citations

Examining changes in binge-eating disorder network centrality and structure in patients treated with cognitive-behavioral therapy versus interpersonal psychotherapy. [2023]
Breaking the cycle: Identifying key symptom pathways of eating disorders and the influence of childhood maltreatment. [2023]
Eating Disorder Symptom and Fear Change Trajectories During Imaginal Exposure Therapy: A Slope Network Analysis. [2023]
Latent trajectories of symptom change during cognitive-behavior therapy predict post-treatment worsening of symptoms: a preliminary examination among outpatients with bulimia-spectrum eating disorders. [2022]
Experiences of Enhanced Cognitive Behaviour Therapy for Bulimia Nervosa. [2018]
Prognostic value of rapid response to enhanced cognitive behavioral therapy in a routine clinic sample of eating disorder outpatients. [2022]
Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial. [2021]
A pilot randomized controlled trial of transdiagnostic network-informed personalized treatment for eating disorders versus enhanced cognitive behavioral therapy. [2023]
A pragmatic effectiveness study of 10-session cognitive behavioural therapy (CBT-T) for eating disorders: Targeting barriers to treatment provision. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity