Personalized Treatment for Eating Disorders

(T-NIPT-ED Trial)

Overseen By Jaelin Isquith, B.A.

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a personalized treatment for eating disorders (EDs) that considers each person's unique situation and social context. Researchers will compare a new personalized approach, Transdiagnostic Network Informed Personalized Treatment (T-NIPT-ED), with the current gold-standard treatment, Cognitive Behavioral Therapy Enhanced (CBT-E), to determine which is more effective. The trial seeks participants with an active eating disorder diagnosis, such as anorexia nervosa or other specified feeding or eating disorders, but not Avoidant/Restrictive Food Intake Disorder (ARFID). Participants should not have active suicidality, mania, or psychosis. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to more effective, personalized treatments 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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E) is generally safe. It has proven effective, particularly for bulimia nervosa and binge eating disorder. Most patients tolerate CBT-E well, with no major safety concerns reported in studies.

Early studies on Transdiagnostic Network Informed Personalized Treatment (T-NIPT-ED) suggest it is also safe. This new method uses personal data to tailor treatment and has shown promise in improving recovery rates. Initial trials have noted no significant safety issues.

Both treatments appear well-tolerated, with few side effects reported. Safety remains a top priority in research, and these treatments have shown promise in that area. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for eating disorders because they offer a personalized approach. Unlike standard therapies like Cognitive Behavioral Therapy (CBT) alone, the Transdiagnostic Network Informed Personalized Treatment tailors sessions based on real-time data from participants' daily experiences, making the treatment more individualized. This approach is expected to address the unique needs of each patient more effectively, potentially improving outcomes by focusing on the specific patterns and triggers that contribute to their eating disorder.

What evidence suggests that this trial's treatments could be effective for eating disorders?

This trial will compare Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E) with Transdiagnostic Network Informed Personalized Treatment. Research has shown that CBT-E effectively treats various eating disorders, particularly bulimia nervosa and binge eating disorder, leading to significant patient improvements. Despite its proven benefits, CBT-E remains underutilized.

In contrast, the Transdiagnostic Network Informed Personalized Treatment, which participants in this trial may receive, is a newer approach. Early results from pilot studies suggest it could be effective by focusing on each patient's individual needs and specific treatment methods, such as reducing feelings of shame. This personalized approach aims to provide more tailored treatment, potentially improving outcomes for people with eating disorders by considering the unique factors affecting each person. ^{3 4 5 6 7}

Who Is on the Research Team?

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?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

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]

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This study aimed to explore patients' experiences undergoing Internet-based guided self-help treatment based on Enhanced Cognitive Behavior Therapy (ICBT-E)