Clinical trial NCT05920720: Self-Guided Personalized Treatment for Women
Official title: Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disordered Eating
Keywords: Treatment
Therapy
Anorexia Nervosa
Bulimia Nervosa
Binge Eating Disorder
Atypical Anorexia Nervosa
Other specified feeding and eating disorder
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disordered eating symptoms
timeFrame: Up to 8 weeks
measure: Anxiety
timeFrame: Up to 8 weeks
measure: Depression
timeFrame: Up to 8 weeks
measure: Clinical Impairment
timeFrame: Up to 8 weeks
measure: Quality of life
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eating Anxiety Treatment Laboratory and Clinic
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Cheri A Levinson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.