Self-Guided Personalized Treatment for Eating Disorders

Overseen By Abigail K McCarthy, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Active mania, suicidality, psychosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Self-guided Personalized Treatment for eating disorders?

Research suggests that patients' positive expectations about treatment success can significantly impact their recovery from eating disorders. Additionally, personalized approaches that consider individual symptoms and needs, like the Self-guided Personalized Treatment, may improve outcomes by targeting specific issues more effectively. ^{1 2 3 4 5}

How does the self-guided personalized treatment for eating disorders differ from other treatments?

This treatment is unique because it is a self-guided approach based on cognitive-behavioral principles, allowing individuals to manage their eating disorders with minimal professional intervention. It is cost-effective, scalable, and can be delivered through various means such as face-to-face or online, making it accessible to a wider range of people compared to traditional therapies. ^{1 6 7 8 9}

Research Team

Cheri A Levinson

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for women aged 18-65 who recognize they have disordered eating, as indicated by a specific score on an eating disorder assessment. Participants must be able to read and write English and own a smartphone or tablet.

Inclusion Criteria

I am between 18 and 65 years old.

Endorse disordered eating (score of 2.3 or above on EDE-Q6)

Ability to read and write English

Exclusion Criteria

Active suicidality

Active psychosis

Active mania

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Smart-phone self-monitoring

Treatment

Participants receive two self-guided modules of personalized treatment on their smart-phones

8 weeks

Baseline, week 5, and week 8 assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Self-guided Personalized Treatment

Trial Overview The study is testing a self-guided mobile intervention designed to help women manage their disordered eating. It involves two weeks of monitoring followed by personalized treatment modules delivered via smartphones over two months.

Participant Groups

Group I: Self-guided Personalized Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study of 84 patients undergoing treatment for eating disorders, those with anorexia used the self-monitoring app Recovery Record significantly more than those with bulimia, especially in the later weeks of treatment.

Overall app usage declined over the 26-week period, with factors like older age and no prior treatment linked to higher app engagement, suggesting that these characteristics may influence how patients interact with digital tools in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient use of a self-monitoring app during eating disorder treatment: Naturalistic longitudinal cohort study. Lindgreen, P., Lomborg, K., Clausen, L.[2023]

The study aims to improve treatment for eating disorders (EDs) by developing personalized models that account for individual differences in symptoms and pathology, as up to 50% of individuals do not respond to standard Enhanced Cognitive-Behavioral Therapy (CBT-E).

By collecting data from 120 participants over 30 days using a mobile app and a sensor wristband, the research will identify specific behavioral and physiological targets that predict treatment outcomes and remission, potentially leading to more effective, tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized networks of eating disorder symptoms predicting eating disorder outcomes and remission. Levinson, CA., Cash, E., Welch, K., et al.[2021]

Guided self-help (GSH) for eating disorders is a promising treatment option, especially for children and adolescents, where access to traditional therapies is often limited.

This study provides detailed insights into online GSH sessions, highlighting how they differ from standard family-based therapy (FBT) delivered via videoconferencing, which could enhance understanding and implementation of these methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying online parental guided self-help family-based treatment for adolescent anorexia nervosa: A comparison to family-based treatment delivered by videoconferencing. Couturier, J., Webb, C., Carson, N., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient use of a self-monitoring app during eating disorder treatment: Naturalistic longitudinal cohort study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient expectations, eating disorder severity and personality features: Impact on eating pathology in psychological therapy for eating disorders. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Profile analysis of treatment effect changes in eating disorder indicators. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Personalized networks of eating disorder symptoms predicting eating disorder outcomes and remission. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Expectations and experiences of treatment in eating disorders. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Applying online parental guided self-help family-based treatment for adolescent anorexia nervosa: A comparison to family-based treatment delivered by videoconferencing. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[How effective and acceptable is a self-treatment manual with concomitant brief therapy in bulimia nervosa]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral guided self-help for eating disorders: effectiveness and scalability. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. [2021]