PT: Personalized Treatment

• Sponsor: University of Louisville (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04183894
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders; Eating Disorder Symptom	Behavioral: Personalized Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Network-Informed Personalized Treatment for Eating Disorders
• Actual Study Start Date: Nov 2, 2018
• Anticipated Primary Completion Date: Sep 2, 2022
• Anticipated Study Completion Date: Nov 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized Intervention Based on Network Participants will receive personalized interventions based on their personalized network.	Behavioral: Personalized Intervention; Participants will receive a personalized intervention based on their personalized network.

Outcome Measures

Primary Outcome Measures

1. Eating Disorder Symptoms [Prior to, during, and after personalized intervention through approximately one year.]

   Changes in eating disorder symptoms will be measured at one month, six month, and 1 year follow-up questionnaires.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40292

Sponsors and Collaborators

• University of Louisville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.

• Responsible Party: Cheri Levinson, Assistant Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT04183894
• Other Study ID Numbers: IRB# 18.0622
• First Posted: Dec 3, 2019
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cheri Levinson, Assistant Professor, University of Louisville: eating disorder; network analysis; personalized treatment; mobile app
• Additional relevant MeSH terms: Disease; Feeding and Eating Disorders

Study Results

No Results Posted as of Jan 5, 2022