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Completed

NCT Number: NCT05499676

Helping HAND: Healing Anorexia Nervosa Digitally

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto University, Palo Alto, California, United States

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About this study

Anorexia nervosa (AN) is a costly and life-threatening illness. Patients with severe AN are often treated in the acute setting, but relapse after treatment is common. Further, the discharge criterion in acute settings is typically weight restoration. However, research has indicated that weight-based recovery is not "enough" and that full recovery involves physical, behavioral, and psychological components. Cognitive-behavioral therapy (CBT) is useful with this population, including following discharge, and may aid in addressing psychological symptoms, achieving full recovery, and decreasing relapse. However, very few patients have access to providers trained in these techniques. mHealth technologies have great potential to exponentially increase access to high-quality services for the post-acute treatment of AN by addressing barriers to treatment, but to date, research on these approaches has been extremely limited. A guided self-help CBT-based mobile app, StudentBodies-Eating Disorders (SB-ED), has been successfully developed, demonstrating effectiveness among college women with binge/purge-type EDs. At the same time, there is demonstrated support for in-person CBT for the post-acute care and relapse prevention of adult AN. The overarching goal of this R34 is thus to develop and test a CBT-based, coached mobile app to address the post-acute care and relapse prevention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cisgender women who are 18 years old and older, who own a mobile phone, speak English, are U.S. residents, have a BMI greater than or equal to 17, who are connected with a physician (such as a primary care provider), who are not using a feeding tube, and who have been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months.

Exclusion criteria

  • Individuals who are not cisgender women.
  • Individuals under 18 years old.
  • Individuals who do not own a mobile phone.
  • Individuals who have not been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months).
  • Individuals who are not connected with a physician (such as a primary care provider)
  • Individuals who have a BMI below 17.0
  • Individuals who are currently using a feeding tube

Treatment and study plan

SilverCloud Health Mobile Intervention

Device

SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs, including one for anorexia nervosa developed by our team. Participants in this arm will receive the support of a coach to guide them through the program. Participants will be able to communicate with their coach within the program.

Social Networking Intervention: Facebook

Device

Facebook is a social networking site that will offer participants the opportunity to interact with study team posts, post themselves, and connect with others in the study experiencing similar struggles in a private group

Primary outcomes

  1. Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Eating Disorder Psychopathology, as Assessed by the Eating Disorder Examination-Questionnaire.

    Time frame: baseline, 6 weeks, 6 months, and 9 months

    Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. The main outcome variable will be the EDE-Q Global score, an overall measure of eating disorder psychopathology. Scores possible range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.

Secondary outcomes

  1. Number of Participants With Any Reported Eating Behaviors in the Mobile App Conditions Compared to Referral to Usual Care.

    Time frame: baseline, 6 weeks, 6 months, and 9 months

    Investigators will use the Eating Disorder Examination-Questionnaire (EDE-Q), a 28-item measure derived from a diagnostic interview, the standard measure of eating disorder psychopathology. For this secondary outcome, investigators will examine eating disorder behavior frequencies from the EDE-Q.

  2. Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Body Mass Index (BMI).

    Time frame: baseline, 6 weeks, 6 months, and 9 months

    Investigators will use current BMI as derived from self-reported height, which has shown to be accurate in adult ED populations, and weight assessed by a digital wireless scale. At each of the study timepoints, a study coordinator will schedule a time with the participant to take their weight while they are on a Zoom call with the coordinator. Participants will be instructed to take off their shoes, wear light clothing, and empty their pockets, similar to the instructions that would be provided if this measurement were being taken in person. Given the use of a wireless scale, the measurement will be able to be immediately and automatically sent to the research team.

  3. Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Depression, as Assessed by the Patient Health Questionnaire.

    Time frame: baseline, 6 weeks, 6 months, and 9 months

    Investigators will use the Patient Health Questionnaire (PHQ-9), a 9-item measure that is widely used to assess presence of possible depression and severity. Scores possible range from 0 to 27, with higher scores indicating greater severity of depression.

  4. Effectiveness of the Mobile App Conditions, Compared to Referral to Usual Care, in Changing Clinical Impairment, as Assessed by the Clinical Impairment Assessment.

    Time frame: baseline, 6 weeks, 6 months, and 9 months

    Investigators will use the Clinical Impairment Assessment (CIA), which is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features. Scores range from 0 to 48 with higher scores indicating higher levels of impairment.

Other outcomes

  1. Number of Participants Who Indicated Rehospitalization in the Mobile App Conditions Compared to Referral to Usual Care.

    Time frame: 6 months and 9 months

    To assess rehospitalization and other treatment utilization, investigators will use a detailed treatment history questionnaire. Rehospitalization rates will be compared across conditions at 6 months and 9 months.

  2. Number of Participants Who Achieved Full Recovery in the Mobile App Conditions Compared to Referral to Usual Care, as Assessed With BMI, the Stanford-Washington University Eating Disorders Screen, and EDE-Q.

    Time frame: 6 months and 9 months

    For recovery, at 6- and 9-month assessments, investigators will compare the percent of participants across study conditions who have achieved full recovery from an eating disorder, comprised of: 1) physical recovery based on having a BMI ≥ 18.5 kg/m2; 2) behavioral recovery based on absence of binge eating, vomiting, laxative use, and fasting in the past 3 months (assessed via the Stanford-Washington University Eating Disorder Screen); and 3) cognitive recovery based on scoring within 1 SD of community norms for each of the EDE-Q subscales.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Development and Pilot Testing of a Cognitive-Behavioral Therapy-Guided Self-Help Mobile App for the Post-Acute Treatment of Anorexia Nervosa

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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