Personalized Treatment vs Cognitive Behavioral Therapy for Eating Disorders

(PT Trial)

Overseen By Taylor E Gardner, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: High suicidality, Active mania, Medically compromised, others

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

Compensation: Varies

Number of Visits: 20

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new personalized treatment for eating disorders is more effective than the standard therapy, Cognitive Behavioral Therapy (CBT). Researchers seek to discover whether tailoring treatment to each individual improves eating disorder symptoms, body weight, and quality of life. The trial includes two groups: one receiving personalized treatment and the other receiving CBT. Suitable participants include those diagnosed with an eating disorder, such as anorexia or bulimia, who are not currently undergoing therapy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It only mentions that you cannot be receiving psychological treatment focused on eating disorders.

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

Research has shown that personalized treatments for eating disorders hold promise. These treatments are tailored to each individual, potentially leading to better outcomes. However, specific information about side effects or safety for these personalized treatments remains limited. As this area is still under study, participants should discuss possible risks and benefits with the trial staff.

In contrast, Cognitive Behavioral Therapy for Eating Disorders (CBT-E) is a well-established treatment. It has been extensively used and studied, proving to be generally safe and well-tolerated. Most individuals experience no major side effects, making CBT-E a reliable option for many with eating disorders.

When considering joining a trial, it is important to weigh the potential benefits of new personalized treatments against the known safety of CBT-E. Always consult healthcare professionals to make the best decision for your health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a personalized approach to tackling eating disorders, which could be more effective than traditional methods like standard Cognitive Behavioral Therapy (CBT). The personalized treatment is unique because it tailors the therapy sessions to each individual's specific needs, potentially leading to better outcomes. Additionally, both treatments incorporate mobile applications, making the therapy more accessible and engaging for participants. This combination of personalization and technology could revolutionize how we treat eating disorders, offering hope for more precise and adaptable therapy options.

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

Research has shown that personalized treatments for eating disorders, such as Network Informed Personalized Treatment (NA-PT), might outperform standard therapies. Studies have found that current treatments benefit only about 31% of people with Anorexia Nervosa and 68% with Bulimia. Early results suggest that NA-PT, which addresses specific issues like feelings of shame and weight concerns, could lead to better outcomes. This treatment customizes care using personal information, aiming to enhance intervention effectiveness and improve patients' quality of life. In this trial, participants will receive either Personalized Treatment for Eating Disorders or Enhanced Cognitive Behavioral Therapy (CBT-E), a well-known method that effectively reduces eating disorder symptoms in many patients. Both treatments are being tested to determine which works better for people with eating disorders. ^{1 4 6 7 8}

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 eating disorder as defined by the DSM-5, including Anorexia Nervosa (AN), Bulimia Nervosa (BN), Binge Eating Disorder (BED), or Other Specified Feeding or Eating Disorder (OSFED). Participants should not be in any other psychological treatment for their eating disorder and must have a stable weight above 75% of the median BMI for their age, sex, and height.

Inclusion Criteria

I have been diagnosed with an eating disorder according to DSM-5.

You are not currently receiving therapy for an eating disorder.

Exclusion Criteria

My weight is very low for my age, sex, and height.

I am over 65 years old.

I am currently receiving psychological therapy for an eating disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Mobile Application

Participants complete 3 sessions of education about the treatment and 2 weeks of mobile application questions

2 weeks

3 sessions (in-person or virtual)

Treatment

Participants undergo 17 sessions of either personalized treatment for eating disorders or Cognitive Behavioral Therapy for Eating Disorders

Varies

17 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Eating Disorders
• Personalized Treatment for Eating Disorders

Trial Overview The study compares two treatments: Network Informed Personalized Treatment (NA-PT) designed specifically based on individual patterns versus Enhanced Cognitive Behavioral Therapy (CBT-E), which is a current standard therapy. The goal is to see if personalized treatment can lead to better outcomes like symptom improvement and quality of life.

How Is the Trial Designed?

Group I: Personalized Treatment for Eating Disorders Experimental Treatment 1 Intervention

Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders.

Group II: Cognitive Behavioral Therapy for Eating Disorders Active Control 1 Intervention

Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders.

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 65 adult women with eating disorders, those who completed integrated group cognitive-behavioral therapy (CBT) showed significant improvements in eating attitudes, mood, coping skills, and self-esteem after 10 sessions.

After a 10-year follow-up, patients who completed the group CBT had a better prognosis compared to those who dropped out, highlighting the long-term benefits of completing group therapy in developing social skills and self-awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-year follow-up study of completers versus dropouts following treatment with an integrated cognitive-behavioral group therapy for eating disorders. Okamoto, Y., Miyake, Y., Nagasawa, I., et al.[2022]

Cognitive behavioral therapy (CBT) is the most effective evidence-based treatment for bulimia nervosa, and an enhanced version of CBT shows even greater effectiveness for various eating disorders.

The enhanced CBT is based on a 'transdiagnostic' theory, making it applicable not only to bulimia nervosa but also to anorexia nervosa and other unspecified eating disorders, broadening its therapeutic reach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for eating disorders. Murphy, R., Straebler, S., Cooper, Z., et al.[2022]

Enhanced Cognitive Behavioral Therapy (CBT-E) shows promise in treating a range of eating disorders, including anorexia nervosa and bulimia nervosa, based on a review of six studies, although the evidence is still considered tentative as CBT-E is in early testing phases.

CBT-E is unique because it tailors treatment to the specific symptoms of individual clients rather than applying a one-size-fits-all approach, making it a potentially effective option for those with chronic eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is enhanced cognitive behavioral therapy an effective intervention in eating disorders? A review. Groff, SE.[2022]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

Cognitive Behavioral Therapy (CBT) is the first-line treatment for bulimia nervosa and binge-eating disorder, and an enhanced version (CBT-E) is particularly effective for patients with severe comorbid conditions.

While CBT-E shows promise for treating adolescent anorexia nervosa, it is not more effective than standard specialist care for adults with persistent anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavior Therapy for the Eating Disorders. Agras, WS.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983806/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789425000401

What Makes Personalized Treatment Work? Mechanisms ... This study sought to identify treatment mechanisms. Several treatment mechanisms (shame, overvaluation of weight) evidenced reductions.

3. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01290-2

Personalised and precision mental health in eating disorders This paper outlines the rationale for the collection of routine outcome data in eating disorder treatment settings, the three existing frameworks proposed,

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1414439/full

An advanced Artificial Intelligence platform for a ... Results: Anticipated outcomes include enhanced care accessibility and efficiency, personalized treatment plans leading to improved patient ...

5. clinicaltrial.be clinicaltrial.be/en/details/34302?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Personalized Treatment for Eating Disorders Versus CBT-E... The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04183894

Study Details | NCT04183894 | Personalized Treatment This study aims to 1) determine if personalized treatments can be conducted using a network analysis of patient symptoms, and 2) to assess the effectiveness of ...

7. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01259-1

Using network analysis to personalize treatment for ... The overarching goal of this larger study is to identify potential shared risk factors for suicide-related outcomes in AN and AAN using real- ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/10503307.2024.2360445

Full article: Using clinician and patient input to assess utility ... Objective. Eating disorders (EDs) take a life every 52 minutes and treatments are ineffective for ∼50% of individuals.