Back to resultsPersonalized Treatment (PT)
Primary Purpose
Eating Disorders, Eating Disorder Symptom
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring eating disorder, network analysis, personalized treatment, mobile app
Eligibility Criteria
Inclusion Criteria:
- Current eating disorder diagnosis
- at least 18 years of age,
- not actively suicidal,
- not manic,
- not psychotic
Exclusion Criteria:
- No current eating disorder diagnosis,
- younger than 18 years of age,
- active psychosis,
- active mania, or
- actively suicidal.
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalized Intervention Based on Network
Arm Description
Participants will receive personalized interventions based on their personalized network.
Outcomes
Primary Outcome Measures
Eating Disorder Symptoms
Changes in eating disorder symptoms will be measured at one month, six month, and 1 year follow-up questionnaires.
Secondary Outcome Measures
Full Information
NCT ID
NCT04183894
First Posted
November 20, 2019
Last Updated
April 25, 2023
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT04183894
Brief Title
Personalized Treatment
Acronym
PT
Official Title
Feasibility of Network-Informed Personalized Treatment for Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
January 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Personalized Treatment Study creates an individualized network of symptoms for a participant with a current eating disorder. This network will be used to develop a personalized treatment intervention. 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 network-informed personalized treatment for participants with eating disorders.
Detailed Description
Cognitive behavioral theory proposes that cognitions, behaviors, affect, and physiological symptoms interact with each other to maintain and exacerbate psychiatric disorders (Beck, 2011). Network theory identifies core symptoms that maintain and promote the spread of ED psychopathology within individuals (Borsboom & Cramer, 2013). Once identified, core "trigger" symptoms can be directly targeted to disrupt the spread or "activation" of ED behaviors, which would help patients achieve full recovery, and ultimately, prevent relapse. One of the main goals of the Personalized Treatment Study is to create an individualized network for a participant with a current eating disorder, which can be used to develop a personalized treatment intervention. Our research questions are: 1) Can a personalized treatment plan be conducted from a network analysis of patient symptoms, and 2) How effective is this personalized treatment based off of a network of symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Eating Disorder Symptom
Keywords
eating disorder, network analysis, personalized treatment, mobile app
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Intervention Based on Network
Arm Type
Experimental
Arm Description
Participants will receive personalized interventions based on their personalized network.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Intervention
Intervention Description
Participants will receive a personalized intervention based on their personalized network.
Primary Outcome Measure Information:
Title
Eating Disorder Symptoms
Description
Changes in eating disorder symptoms will be measured at one month, six month, and 1 year follow-up questionnaires.
Time Frame
Prior to, during, and after personalized intervention through approximately one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current eating disorder diagnosis
at least 18 years of age,
not actively suicidal,
not manic,
not psychotic
Exclusion Criteria:
No current eating disorder diagnosis,
younger than 18 years of age,
active psychosis,
active mania, or
actively suicidal.
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Beck, J. S. (2011). Cognitive-behavioral therapy. Clinical textbook of addictive disorders, 491, 474-501.
Results Reference
background
PubMed Identifier
23537483
Citation
Borsboom D, Cramer AO. Network analysis: an integrative approach to the structure of psychopathology. Annu Rev Clin Psychol. 2013;9:91-121. doi: 10.1146/annurev-clinpsy-050212-185608.
Results Reference
background
PubMed Identifier
34736538
Citation
Levinson CA, Hunt RA, Keshishian AC, Brown ML, Vanzhula I, Christian C, Brosof LC, Williams BM. Using individual networks to identify treatment targets for eating disorder treatment: a proof-of-concept study and initial data. J Eat Disord. 2021 Nov 4;9(1):147. doi: 10.1186/s40337-021-00504-7. Erratum In: J Eat Disord. 2022 Jul 11;10(1):99.
Results Reference
derived
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Personalized Treatment
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