NCT05563649

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Mar 2023Oct 2027

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 17, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

June 26, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

September 28, 2022

Last Update Submit

June 24, 2025

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Ratio of therapist hours to %EBW change

    The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.

    Assessed from baseline through end of treatment (EOT)

Secondary Outcomes (3)

  • Eating Disorder Examination (EDE)

    Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up

  • Beck Depression Inventory (BDI)

    These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up)

  • Beck Anxiety Inventory (BAI)

    Baseline, sessions 2, 4, 6, 8, and EOT

Study Arms (2)

Online Guided Self-Help-Family-based Treatment (GSH-FBT)

EXPERIMENTAL

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.

Behavioral: Online Guided Self-Help-Family-based Treatment

FBT via Videoconferencing (FBT-V)

ACTIVE COMPARATOR

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.

Behavioral: FBT via Videoconferencing

Interventions

Online Guided Self-Help-Family-based TreatmentBEHAVIORAL

GSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an 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. Three lectures include additional resources for parents (e.g., Academy of Eating Disorder (AED) Medical Management Guidelines). Homework assignments are included with some lectures (e.g., strategies to help the child eat during meals, practice making calorically dense meals). In line with GSH approaches, coach-therapists direct parents, to watch or re-watch specific video content contained in the online learning material related to their questions rather than direct behavioral change.

Also known as: GSH-FBT
Online Guided Self-Help-Family-based Treatment (GSH-FBT)
FBT via VideoconferencingBEHAVIORAL

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.

Also known as: FBT-V
FBT via Videoconferencing (FBT-V)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

RECRUITING

McMaster University

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Central Study Contacts

Ainsley E Cogburn, B.S.

CONTACT

6507239182familytreatment@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

March 17, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)