Self-Guided Personalized Treatment for Women

Study Overview
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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.

Official Title
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Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women

Conditions
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Disordered Eating

Intervention / Treatment
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* Behavioral: Self-guided Personalized Treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-guided Personalized Treatment<br>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. | Behavioral: Self-guided Personalized Treatment<br>* 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.<br>* Other names: Personalized Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disordered eating symptoms | Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6) | Up to 8 weeks | 
| Anxiety | Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ) | Up to 8 weeks | 
| Depression | Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2) | Up to 8 weeks | 
| Clinical Impairment | Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA) | Up to 8 weeks | 
| Quality of life | Changes in quality of life will be assessed with the Quality of Life Scale (QOLS) | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapy, Treatment, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Atypical Anorexia Nervosa, Other specified feeding and eating disorder