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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04183894
Other study ID # IRB# 18.0622
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2018
Est. completion date January 23, 2023

Study information

Verified date April 2023
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date January 23, 2023
Est. primary completion date January 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Personalized Intervention
Participants will receive a personalized intervention based on their personalized network.

Locations

Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (2)

Beck, J. S. (2011). Cognitive-behavioral therapy. Clinical textbook of addictive disorders, 491, 474-501.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Disorder Symptoms Changes in eating disorder symptoms will be measured at one month, six month, and 1 year follow-up questionnaires. Prior to, during, and after personalized intervention through approximately one year.
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