Personalized Treatment for Eating Disorders

(T-NIPT-ED Trial)

Overseen By Cheri A Levinson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Active suicidality, active mania, active psychosis

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

Compensation: Varies

Number of Visits: 11

320 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 4 5 6 7}

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. ^{1 4 5 8 9}

Research Team

Cheri A Levinson, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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.

I am between 18 and 65 years old.

Exclusion Criteria

Active Suicidality

Active Mania

Active psychosis

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Transdiagnostic Network Informed Personalized Treatment Experimental Treatment 1 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 Disorders Active Control 1 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:

Approved in United States as CBT-E for:

• Anorexia Nervosa
• Bulimia Nervosa
• Binge Eating Disorder
• Other Specified Feeding or Eating Disorder

Approved in European Union as CBT-E for:

• Anorexia Nervosa
• Bulimia Nervosa
• Binge Eating Disorder
• Other Specified Feeding or Eating Disorder

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating Disorder Symptom and Fear Change Trajectories During Imaginal Exposure Therapy: A Slope Network Analysis. Nicholas, JK., Cusack, CE., Levinson, CA.[2023]

In a study of 56 participants with bulimia nervosa undergoing 16 sessions of cognitive behavior therapy (CBT), specific patterns of change in eating disorder symptoms were identified that can predict worsening symptoms after treatment.

Individuals who showed a rapid increase in binge eating frequency were more likely to experience a recurrence of compensatory behaviors, suggesting that monitoring these trajectories can help personalize treatment for better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Presseller, EK., Lampe, EW., Michael, ML., et al.[2022]

Participants in the study valued the expertise and empathy of therapists specializing in eating disorders, which enhanced their experience of Cognitive Behaviour Therapy (CBT-E).

Key benefits of CBT-E included gaining insight into the cycles that maintain their eating disorders and experiential learning, while challenges included the difficulty of changing long-standing behaviors and beliefs both immediately and over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Enhanced Cognitive Behaviour Therapy for Bulimia Nervosa. Onslow, L., Woodward, D., Hoefkens, T., et al.[2018]

In a study of 105 patients with eating disorders undergoing enhanced cognitive behavioral therapy (CBT-E), those who showed a rapid response within 4.6 weeks had significantly better treatment outcomes, including lower eating disorder symptoms and higher rates of full remission.

Rapid responders required fewer treatment sessions compared to nonrapid responders, highlighting the importance of early improvement in therapy for achieving optimal results, although nonrapid responders still showed significant symptom improvement overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of rapid response to enhanced cognitive behavioral therapy in a routine clinic sample of eating disorder outpatients. Raykos, BC., Watson, HJ., Fursland, A., et al.[2022]

In a randomized controlled trial with 143 adult patients, enhanced cognitive behavior therapy (CBT-E) showed a significantly higher recovery rate from eating disorders (57.7%) at 20 weeks compared to treatment as usual (TAU) (36.0%).

CBT-E was found to be more effective in improving self-esteem and was less intensive and shorter than TAU, suggesting that its broader implementation could enhance treatment efficiency and accessibility for eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial. de Jong, M., Spinhoven, P., Korrelboom, K., et al.[2021]

This study will compare the effectiveness of a new personalized treatment approach for eating disorders (T-NIPT-ED) against the standard Enhanced Cognitive Behavioral Therapy (CBT-E) in a randomized controlled trial involving multiple assessments over treatment and follow-up periods.

The research aims to determine if targeting specific symptoms identified through a network-informed approach can lead to better treatment outcomes, potentially addressing the high relapse rates and low recovery rates currently seen in eating disorder treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of transdiagnostic network-informed personalized treatment for eating disorders versus enhanced cognitive behavioral therapy. Butler, RM., Ortiz, AML., Pennesi, JL., et al.[2023]

A ten-session cognitive behavioural therapy (CBT-T) for transdiagnostic eating disorders showed significant improvements in eating disorder cognitions, behaviors, quality of life, and negative affect among 52 patients treated by trainee psychologists, with medium to large effect sizes observed from baseline to post-treatment and at follow-ups.

The study indicates that CBT-T can effectively address barriers to treatment, such as cost and access, with a comparable attrition rate of 38.5% to other treatment studies, suggesting it is a viable option for patients with eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic effectiveness study of 10-session cognitive behavioural therapy (CBT-T) for eating disorders: Targeting barriers to treatment provision. Pellizzer, ML., Waller, G., Wade, TD.[2020]

References

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

Examining changes in binge-eating disorder network centrality and structure in patients treated with cognitive-behavioral therapy versus interpersonal psychotherapy. [2023]

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

Breaking the cycle: Identifying key symptom pathways of eating disorders and the influence of childhood maltreatment. [2023]

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

Eating Disorder Symptom and Fear Change Trajectories During Imaginal Exposure Therapy: A Slope Network Analysis. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

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]

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

Experiences of Enhanced Cognitive Behaviour Therapy for Bulimia Nervosa. [2018]

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

Prognostic value of rapid response to enhanced cognitive behavioral therapy in a routine clinic sample of eating disorder outpatients. [2022]

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

Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial. [2021]

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

A pilot randomized controlled trial of transdiagnostic network-informed personalized treatment for eating disorders versus enhanced cognitive behavioral therapy. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A pragmatic effectiveness study of 10-session cognitive behavioural therapy (CBT-T) for eating disorders: Targeting barriers to treatment provision. [2020]