Helping HAND: Healing Anorexia Nervosa Digitally

• ClinicalTrials.gov Identifier: NCT05499676
• Recruitment Status: Recruiting
• First Posted: August 12, 2022
• Last Update Posted: December 2, 2022
• Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Ellen E. Fitzsimmons-Craft, Washington University School of Medicine

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anorexia Nervosa	Device: SilverCloud Health Mobile Intervention; Device: Social Networking Intervention: Facebook	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development and Pilot Testing of a Cognitive-Behavioral Therapy-Guided Self-Help Mobile App for the Post-Acute Treatment of Anorexia Nervosa
• Actual Study Start Date: December 1, 2022
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: December 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mobile Coached Intervention; Participants randomized to the mobile intervention condition will receive access to the mobile app for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged.	Device: SilverCloud Health Mobile Intervention; 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.
Experimental: Mobile Coached Intervention Plus Social Networking; Participants randomized to the mobile intervention plus social networking condition will receive access to the mobile app, as well as Facebook social networking component, for 6 consecutive months. Participants will still be able to access other usual care options and will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged.	Device: SilverCloud Health Mobile Intervention; 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.; Device: Social Networking Intervention: Facebook; 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
No Intervention: Treatment as Usual; This group will be encouraged to follow the discharge plan provided to them by the eating disorder program from which they were discharged. Participants will also be encouraged to follow-up with their eating program for additional referral information as needed and/or to reach out to the National Eating Disorders Association (NEDA) and/or Association for Anorexia Nervosa and Associated Disorders (ANAD ) for assistance with finding treatment providers/resources as needed. NEDA and ANAD provide helplines and online treatment provider databases to help individuals find providers.

Outcome Measures

Primary Outcome Measures :

1. 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 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. Change in EDE-Q scores will be compared from baseline to 6 months and baseline to 9 months.

Secondary Outcome Measures :

1. Effectiveness of the mobile app conditions, compared to referral to usual care, in changing eating disorder behaviors. [ Time Frame: baseline, 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. Change in EDE-Q behavior frequencies will be compared from baseline to 6 months and baseline to 9 months.
2. Effectiveness of the mobile app conditions, compared to referral to usual care, in changing Body Mass Index (BMI). [ Time Frame: baseline, 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. Change in BMI will be compared from baseline to 6 months and baseline to 9 months.

3. Effectiveness of the mobile app conditions, compared to referral to usual care, in changing depression and suicidal ideation, as assessed by the Patient Health Questionnaire. [ Time Frame: baseline, 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, as well as suicidality. Scores possible range from 0 to 27, with higher scores indicating greater severity of depression. Change in PHQ scores will be compared from baseline to 6 months and baseline to 9 months.
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 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. Change in CIA scores will be compared from baseline to 6 months and baseline to 9 months.

Other Outcome Measures:

1. Effectiveness of the mobile app conditions, compared to referral to usual care, in terms of reducing rehospitalization. [ 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. Effectiveness of the mobile app conditions, compared to referral to usual care, in terms of achieving full recovery, as assessed with BMI, the Stanford-Washington University Eating Disorders Screen, and the 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Cisgender women
• Accepts Healthy Volunteers: No

Criteria

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, 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).

Contacts and Locations

Contacts

Contact: Ellen Fitzsimmons-Craft, PhD; 314-286-2074; fitzsimmonse@wustl.edu

Contact: Agatha Laboe, BA; 314-249-8352; laboe@wustl.edu

Locations

United States, California

Palo Alto University; Not yet recruiting

Palo Alto, California, United States, 94304

Contact: Agatha Laboe, BA 314-249-8352 laboe@wustl.edu

Contact: Craig B. Taylor, MD btaylor@stanford.edu

United States, Missouri

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Agatha Laboe 314-249-8352 laboe@wustl.edu

Contact: Ellen Fitzsimmons-Craft 314-249-8352 fitzsimmonse@wustl.edu

Principal Investigator: Ellen Fitzsimmons-Craft, PhD

Sub-Investigator: Denise Wilfley

United States, New York

Columbia University; Not yet recruiting

New York, New York, United States, 10032

Contact: Agatha A Laboe, BA 314-249-8352 laboe@wustl.edu

Contact: Kathleen Pike, PhD kmp2@cumc.columbia.edu

Sponsors and Collaborators

Washington University School of Medicine

National Institute of Mental Health (NIMH)

More Information

• Responsible Party: Ellen E. Fitzsimmons-Craft, Associate Professor of Psychiatry, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT05499676
• Other Study ID Numbers: 202202113; R34MH127203 ( U.S. NIH Grant/Contract )
• First Posted: August 12, 2022
• Last Update Posted: December 2, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: De-identified data will not be shared on the National Institute of Mental Health Data Archive, as this is a pilot study.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anorexia; Anorexia Nervosa; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders