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Helping HAND: Healing Anorexia Nervosa Digitally

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The Washington University

Status

Active, not recruiting

Conditions

Anorexia Nervosa

Treatments

Device: Social Networking Intervention: Facebook
Device: SilverCloud Health Mobile Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05499676
202202113
R34MH127203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Mobile Coached Intervention
Experimental group
Description:
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.
Treatment:
Device: SilverCloud Health Mobile Intervention
Mobile Coached Intervention Plus Social Networking
Experimental group
Description:
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.
Treatment:
Device: SilverCloud Health Mobile Intervention
Device: Social Networking Intervention: Facebook
Treatment as Usual
No Intervention group
Description:
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.

Trial contacts and locations

3

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Central trial contact

Ellen Fitzsimmons-Craft, PhD; Carli Howe, BA

Data sourced from clinicaltrials.gov

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