Self-Guided Personalized Treatment for Women

NCT ID: NCT05920720

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-08-15

Brief Summary

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The investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.

Detailed Description

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Conditions

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Disordered Eating

Keywords

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Treatment Therapy Anorexia Nervosa Bulimia Nervosa Binge Eating Disorder Atypical Anorexia Nervosa Other specified feeding and eating disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-guided Personalized Treatment

Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.

Group Type EXPERIMENTAL

Self-guided Personalized Treatment

Intervention Type BEHAVIORAL

Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.

Interventions

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Self-guided Personalized Treatment

Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.

Intervention Type BEHAVIORAL

Other Intervention Names

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Personalized Treatment

Eligibility Criteria

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Inclusion Criteria

* Endorse disordered eating (score of 2.3 or above on EDE-Q6)
* Age 18-65
* Ability to read and write English
* Own a smartphone or tablet

Exclusion Criteria

* Active mania
* Active suicidality
* Active psychosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Cheri Levinson

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheri A Levinson

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, United States

Site Status

Countries

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United States

Central Contacts

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Cheri A Levinson, PhD

Role: CONTACT

Phone: 502-852-7710

Email: [email protected]

Abigail K McCarthy, B.S.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Cheri A Levinson, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 36729494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23537483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34736538 (View on PubMed)

Other Identifiers

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5P20GM103436-23

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#23.0274

Identifier Type: -

Identifier Source: org_study_id