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Personalized Treatment vs Cognitive Behavioral Therapy for Eating Disorders (PT Trial)

N/A
Recruiting
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
Age 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1-month follow-up
Awards & highlights

PT Trial 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.Check my eligibility
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.See study design
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.

PT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am between 18 and 65 years old.
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I have been diagnosed with an eating disorder according to DSM-5.

PT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

PT 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.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,673,930 Total Patients Enrolled
61 Trials studying Eating Disorders
25,080 Patients Enrolled for Eating Disorders
University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,860 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

Cognitive Behavioral Therapy for Eating Disorders Clinical Trial Eligibility Overview. Trial Name: NCT05195840 — N/A
Eating Disorders Research Study Groups: Personalized Treatment for Eating Disorders, Cognitive Behavioral Therapy for Eating Disorders
Eating Disorders Clinical Trial 2023: Cognitive Behavioral Therapy for Eating Disorders Highlights & Side Effects. Trial Name: NCT05195840 — N/A
Cognitive Behavioral Therapy for Eating Disorders 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195840 — N/A
Eating Disorders Patient Testimony for trial: Trial Name: NCT05195840 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this research endeavor?

"Yes, according to clinicaltrials.gov, the research team is currently on the hunt for 80 participants from a single trial site. This study was initially uploaded onto the website on April 6th and edited most recently on April 13th 2022."

Answered by AI

Is it possible for me to take part in this trial?

"This investigation is opening its doors to 80 participants of ages 18 and 65 who are presently dealing with an eating disorder. Additionally, the individuals must not be engaging in any psychological treatment related to their ED at present."

Answered by AI

Does this clinical investigation accept geriatric patients?

"The requirements for inclusion in this clinical trial are that applicants possess an age between 18 and 65. There are 271 studies available for patients below the age of majority, while 648 can be found for those senior citizens over 65 years old."

Answered by AI

How many participants are accepted into this experimental program?

"Indeed, the clinicaltrials.gov web page demonstrates that this scientific endeavour is actively looking for subjects to enrol. It was posted on April 6th 2022 and subsequently updated a week later. A total of 80 participants across one site are expected to join in the trial's activities."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Michigan
Minnesota
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Eating Anxiety Treatment Laboratory and Clinic
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

Where can I stay?
PatientReceived no prior treatments

Why did patients apply to this trial?

I need help and I'm tired of living with anorexia. I’ve had Bulimia for over 40 years. I want to stop.
PatientReceived 1 prior treatment
I have been in therapy for last 2 yrs and been going to Eating Disorders Anon. But it is still a destructive force in my life. I struggled with bulimia in 20-30's and now again past 2 yrs in early 60's.
PatientReceived 2+ prior treatments
Recent research and studies
~3 spots leftby May 2024