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Behavioural Intervention
Personalized Treatment for Eating Disorders (T-NIPT-ED 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
Current diagnosis of any active eating disorder except ARFID
Ages 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to develop a personalized treatment for eating disorders (EDs) by considering individual factors and social context. Current treatments for EDs have limited success, and there is a need for more effective
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves therapy rather than medication, side effects may include emotional discomfort or distress due to discussing personal issues during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an active eating disorder, but it's not ARFID.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical impairment
Eating disorder symptoms
Secondary study objectives
Health service utilization using the Health Utilization and Medical Comorbidities
Medical comorbidities using the Health Utilization and Medical Comorbidities
Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdiagnostic Network Informed Personalized TreatmentExperimental Treatment1 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 DisordersActive Control1 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.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,058 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,321 Total Patients Enrolled
Cheri A Levinson, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
210 Total Patients Enrolled