NCT04183894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

4.2 years

First QC Date

November 20, 2019

Last Update Submit

April 25, 2023

Conditions

Eating DisordersEating Disorder Symptom

Keywords

eating disordernetwork analysispersonalized treatmentmobile app

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Personalized Intervention Based on Network

EXPERIMENTAL

Participants will receive personalized interventions based on their personalized network.

Behavioral: Personalized Intervention

Interventions

Personalized InterventionBEHAVIORAL

Participants will receive a personalized intervention based on their personalized network.

Personalized Intervention Based on Network

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current eating disorder diagnosis
  • at least 18 years of age,
  • not actively suicidal,
  • not manic,
  • not psychotic

You may not qualify if:

  • No current eating disorder diagnosis,
  • younger than 18 years of age,
  • active psychosis,
  • active mania, or
  • actively suicidal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Related Publications (4)

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

    BACKGROUND

  • 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.

    PMID: 23537483BACKGROUND

  • Levinson CA, Williams BM, Christian C, Hunt RA, Keshishian AC, Brosof LC, Vanzhula IA, Davis GG, Brown ML, Bridges-Curry Z, Sandoval-Araujo LE, Ralph-Nearman C. Personalizing eating disorder treatment using idiographic models: An open series trial. J Consult Clin Psychol. 2023 Jan;91(1):14-28. doi: 10.1037/ccp0000785.

    PMID: 36729494DERIVED

  • 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.

    PMID: 34736538DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2019

First Posted

December 3, 2019

Study Start

November 2, 2018

Primary Completion

January 23, 2023

Study Completion

January 23, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

US(1)