Eating DisordersPTNCT05195840
Personalized Treatment for Eating Disorders Versus CBT-E Trial
A study testing Personalized Treatment for Eating Disorders and Cognitive Behavioral Therapy for Eating Disorders in people with Eating Disorders, run by University of Louisville at 1 site in United States.
Trial summary
The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Personalized Treatment for Eating Disorders and Cognitive Behavioral Therapy for Eating Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
- Not currently receiving psychological treatment focused on ED
Who cannot join
- Under 18
- Over 65
- Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
- High and active Suicidality
- Active Mania
- Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height
- Simultaneous psychological treatment focused on ED
Trial locations and contacts
1 site in 1 country.
United States1 site
Eating Anxiety Treatment Laboratory and Clinic
Louisville, Kentucky, 40205-1016
About this study
Official title: A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change
The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.
- Conditions
- Eating Disorders
- Being tested
- Personalized Treatment for Eating Disorders, Cognitive Behavioral Therapy for Eating Disorders
- Keywords
- eating disorder, treatment, anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, therapy, other specified feeding and eating disorder
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Treatment for Eating DisordersBehavioural
The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 includes psychoeducation on the network-informed model of personalized treatment and 14 sessions (sessions 5-19) are focused on the top three targets (4-5 sessions per target). Session 20 is a termination and conclusion session.
Cognitive Behavioral Therapy for Eating DisordersBehavioural
The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 consists of food monitoring, addressing irregular eating, challenging thoughts, making adaptive behavioral changes, and relapse prevention. Session 20 is a termination and conclusion session.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Treatment for Eating Disorders | Experimental | Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders. Receives: Behavioral: Personalized Treatment for Eating Disorders |
| Cognitive Behavioral Therapy for Eating Disorders | Active comparator | Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders. Receives: Behavioral: Cognitive Behavioral Therapy for Eating Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Impairment using the Clinical Impairment Assessment
The Clinical Impairment Assessment (CIA), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine the severity of psychosocial impairment caused by eating disorders. The scores range from 0 to 64 with higher scores indicating more impairment.
Measured: Up to 1-Month Follow-Up
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
The Eating Disorder Examination Questionnaire (EDE-Q), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine attitudes and behaviors in individuals with eating disorder symptoms. The scores range from 0-6 with higher scores indicating higher severity of eating disorder symptoms.
Measured: Up to 1-Month Follow-Up
Change in Quality of Life using the Quality of Life Scale
The Quality of Life Scale (QOLS), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine various domains of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life.
Measured: Up to 1-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start6 Apr 2022
- Primary completion30 Nov 2025
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cheri Levinson, University of Louisville
- Investigators
- Cheri A Levinson, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195840
- Sponsor's protocol ID
- IRB#: 21.0689
- Other IDs
- 3R34MH128213-01S1
- Acronym
- PT
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levinson CA, Williams BM. Eating disorder fear networks: Identification of central eating disorder fears. Int J Eat Disord. 2020 Dec;53(12):1960-1973. doi: 10.1002/eat.23382. Epub 2020 Sep 12.
PubMed 32918319Levinson CA, Vanzhula I, Brosof LC. Longitudinal and personalized networks of eating disorder cognitions and behaviors: Targets for precision intervention a proof of concept study. Int J Eat Disord. 2018 Nov;51(11):1233-1243. doi: 10.1002/eat.22952. Epub 2018 Oct 6.
PubMed 30291641Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
PubMed 20599136Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
PubMed 12711261
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change
- ClinicalTrials.gov ID
- NCT05195840
- Acronym / sponsor ID
- PT / IRB#: 21.0689
- Conditions
- Eating Disorders
- Keywords
- eating disorder, treatment, anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, therapy, other specified feeding and eating disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Treatment for Eating Disorders | Experimental | Behavioral: Personalized Treatment for Eating DisordersParticipants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders. |
| Cognitive Behavioral Therapy for Eating Disorders | Active comparator | Behavioral: Cognitive Behavioral Therapy for Eating DisordersParticipants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
- Not currently receiving psychological treatment focused on ED
Key exclusion criteria (7 listed)
- Under 18
- Over 65
- Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
- High and active Suicidality
- Active Mania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Treatment for Eating DisordersThe first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 includes psychoeducation on the network-informed model of personalized treatment and 14 sessions (sessions 5-19) are focused on the top three targets (4-5 sessions per target). Session 20 is a termination and conclusion session. | Behavioural | Personalized Treatment for Eating Disorders |
| Cognitive Behavioral Therapy for Eating DisordersThe first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 consists of food monitoring, addressing irregular eating, challenging thoughts, making adaptive behavioral changes, and relapse prevention. Session 20 is a termination and conclusion session. | Behavioural | Cognitive Behavioral Therapy for Eating Disorders |
Primary outcome
Change in Clinical Impairment using the Clinical Impairment Assessment
Time frame: Up to 1-Month Follow-Up
The Clinical Impairment Assessment (CIA), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine the severity of psychosocial impairment caused by eating disorders. The scores range from 0 to 64 with higher scores indicating more impairment.
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
Time frame: Up to 1-Month Follow-Up
The Eating Disorder Examination Questionnaire (EDE-Q), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine attitudes and behaviors in individuals with eating disorder symptoms. The scores range from 0-6 with higher scores indicating higher severity of eating disorder symptoms.
Change in Quality of Life using the Quality of Life Scale
Time frame: Up to 1-Month Follow-Up
The Quality of Life Scale (QOLS), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine various domains of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 32918319Levinson CA, Williams BM. Eating disorder fear networks: Identification of central eating disorder fears. Int J Eat Disord. 2020 Dec;53(12):1960-1973. doi: 10.1002/eat.23382. Epub 2020 Sep 12.
- Background: PubMed 30291641Levinson CA, Vanzhula I, Brosof LC. Longitudinal and personalized networks of eating disorder cognitions and behaviors: Targets for precision intervention a proof of concept study. Int J Eat Disord. 2018 Nov;51(11):1233-1243. doi: 10.1002/eat.22952. Epub 2018 Oct 6.
- Background: PubMed 20599136Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
- Background: PubMed 12711261Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheri A Levinson, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Treatment for Eating Disorders and Cognitive Behavioral Therapy for Eating Disorders in people with Eating Disorders, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Impairment using the Clinical Impairment Assessment (time frame: Up to 1-Month Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195840, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.