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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: 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 and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.

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.

What data supports the effectiveness of Cognitive Behavioral Therapy for Eating Disorders and Personalized Treatment for Eating Disorders?

Research shows that Cognitive Behavioral Therapy (CBT) is effective for treating bulimia nervosa and binge eating disorder, with some evidence suggesting that a more personalized approach may lead to better outcomes in certain areas like reducing bulimic episodes and body shape dissatisfaction. However, the evidence for its effectiveness in treating anorexia nervosa is still limited. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for treating eating disorders?

Cognitive Behavioral Therapy (CBT) is a well-established and safe treatment for eating disorders like bulimia nervosa and binge eating disorder. It is considered the leading evidence-based treatment and has been adapted for various eating disorders, showing promising results in both adults and adolescents. ^{5 6 7 8 9}

How does Personalized Treatment differ from Cognitive Behavioral Therapy for eating disorders?

Personalized Treatment for eating disorders is unique because it tailors the therapy to the individual's specific needs and characteristics, potentially incorporating various therapeutic approaches, whereas Cognitive Behavioral Therapy (CBT) is a structured, evidence-based treatment focusing on changing negative thought patterns and behaviors associated with eating disorders. ^{7 9 10 11 12}

Research Team

Cheri A Levinson, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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 am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

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

Does individualization matter? A randomized trial of standardized (focused) versus individualized (broad) cognitive behavior therapy for bulimia nervosa. [2022]

2. England 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. [2022]

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

Predictors and moderators of response to enhanced cognitive behaviour therapy and interpersonal psychotherapy for the treatment of eating disorders. [2022]

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

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

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

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

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

Psychological treatment of eating disorders. [2018]

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Treatment of Eating Disorders in Adults Versus Adolescents: Similarities and Differences. [2021]

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

Cognitive behavioral therapy for eating disorders. [2022]

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

Cognitive Behavior Therapy for the Eating Disorders. [2020]

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

A transdiagnostic comparison of enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy in the treatment of eating disorders. [2022]

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

Emerging psychological treatments in the field of eating disorders. [2021]

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

Psychosocial and pharmacological treatment of eating disorders: a review of research findings. [2019]