Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05563649

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Online Guided Self-Help-Family-based Treatment

Behavioral

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.

Other names: GSH-FBT

FBT via Videoconferencing

Behavioral

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.

Other names: FBT-V

Primary outcomes

  1. Ratio of therapist hours to %EBW change

    Time frame: Assessed from baseline through end of treatment (EOT)

    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.

Secondary outcomes

  1. Eating Disorder Examination (EDE)

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

    The EDE is a standardized investigator-based interview that measures the severity of the characteristic psychopathology of eating disorders. The psychometric properties of the EDE are sound and validated in diverse samples. It takes about 1 hour to complete.

  2. Beck Depression Inventory (BDI)

    Time frame: 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)

    The BDI is a measure with sound psychometric properties and was validated on a diverse sample. It has been used in numerous studies of adolescent depression. This measure also includes questions about suicidal ideation and intent and will be used to assess suicide during the study. These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points. It takes about 10 minutes to complete.

  3. Beck Anxiety Inventory (BAI)

    Time frame: Baseline, sessions 2, 4, 6, 8, and EOT

    The BAI is a 21-item questionnaire about anxiety that has sound psychometric properties and was validated on a diverse sample. Assessments will be collected at baseline, sessions 2, 4, 6, 8, and EOT.

Study contacts

Contact information is provided by the study sponsor or research team.

Ainsley E Cogburn, B.S.

CONTACT

[email protected]

6507239182

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Jun 26, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.