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

NCT ID: NCT05563649

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-17
• Study Completion Date: 2027-10-01

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Online Guided Self-Help-Family-based Treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

FBT via Videoconferencing

Intervention Type: 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.

Interventions

Online Guided Self-Help-Family-based Treatment

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.

Intervention Type: BEHAVIORAL

FBT via Videoconferencing

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

GSH-FBT; FBT-V

Eligibility Criteria

Inclusion Criteria

1. Participants are 12-18 years of age

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

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

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

5. EBW above 75%

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

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

8. 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

James Dale Lock

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

United States; Canada

Central Contacts

Ainsley E Cogburn, B.S.

Role: CONTACT

familytreatment@stanford.edu

6507239182

Facility Contacts

Ainsley E Cogburn, B.S.

Role: primary

familytreatment@stanford.edu

6507239182

Sadaf Sami, MD, CCRA

Role: primary

samis2@mcmaster.ca

Other Identifiers

R01MH130388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

67295

Identifier Type: -

Identifier Source: org_study_id