Anorexia Clinical Trials

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Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Participants are 12-18 years of age

• Participants live with a family (some families may contain only one parent)

• Family members fluently speak and read English and have access to a computer with internet

• Participants meet DSM-5 criteria for AN (both subtypes)

• EBW above 75%

• Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine

• Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.

• Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

Locations
United States
California
Stanford University
RECRUITING
Stanford
Other Locations
Canada
McMaster University
RECRUITING
Hamilton
Contact Information
Primary
Ainsley E Cogburn, B.S.
familytreatment@stanford.edu
6507239182
Time Frame
Start Date: 2023-03-17
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 200
Treatments
Experimental: Online Guided Self-Help-Family-based Treatment (GSH-FBT)
GSH-FBT consists of 10 20-minute parent-only sessions over 9 months. The guidance portion is manualized and will be delivered by a clinician familiar with both the online modules and FBT, who acts as a coach. Sessions follow an online curriculum containing a total of 65 short videos. Each lecture series is comprised of a written introduction orienting the viewer to the videos, 5-9 short videos (\< 7 minutes each), and assigned reading from the parent education manual, Help Your Teenager Beat an Eating Disorder. In line with GSH approaches, coaches direct parents to watch or re-watch specific videos contained in the online platform related to their questions.
Active_comparator: FBT via Videoconferencing (FBT-V)
15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov