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Personalized Treatment vs Cognitive Behavioral Therapy for Eating Disorders (PT Trial)
N/A
Waitlist Available
Led By Cheri A Levinson, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65
Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
Must not have
Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height
Over 65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1-month follow-up
Awards & highlights
Summary
This trial is testing a new, personalized treatment for eating disorders (ED), which may be more effective than the current gold-standard treatment. The study goals are to develop and test the new treatment, and to see if it works by targeting specific areas identified in each individual's network.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves psychological therapies rather than medication, side effects are not typical in the same way as drug trials. However, participants may experience emotional discomfort or distress while discussing sensitive topics related to their eating disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have been diagnosed with an eating disorder according to DSM-5.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My weight is very low for my age, sex, and height.
Select...
I am over 65 years old.
Select...
I am under 18 years old.
Select...
I do not have an eating disorder as defined by DSM-5.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Clinical Impairment using the Clinical Impairment Assessment
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
Change in Quality of Life using the Quality of Life Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Treatment for Eating DisordersExperimental Treatment1 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 DisordersActive Control1 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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,881 Previous Clinical Trials
2,798,794 Total Patients Enrolled
61 Trials studying Eating Disorders
24,156 Patients Enrolled for Eating Disorders
University of LouisvilleLead Sponsor
343 Previous Clinical Trials
77,453 Total Patients Enrolled
7 Trials studying Eating Disorders
880 Patients Enrolled for Eating Disorders
Cheri A Levinson, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
450 Total Patients Enrolled
2 Trials studying Eating Disorders
450 Patients Enrolled for Eating Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have a high level of suicidal thoughts or actions.You are currently experiencing a state of extreme excitement or agitation.I am between 18 and 65 years old.I am under 18 years old.I have been diagnosed with an eating disorder according to DSM-5.You are not currently receiving therapy for an eating disorder.I do not have an eating disorder as defined by DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized Treatment for Eating Disorders
- Group 2: Cognitive Behavioral Therapy for Eating Disorders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Eating Disorders Patient Testimony for trial: Trial Name: NCT05195840 — N/A
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