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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two treatments for Anorexia Nervosa in youth to determine if one is more effective and efficient.
Who is the study for?
This trial is for adolescents aged 12-18 with Anorexia Nervosa who live with family, speak English fluently, and have internet access. They must be medically stable for outpatient treatment and not involved in other psychotherapy trials. Medications for other psychiatric conditions are allowed if doses have been consistent.
What is being tested?
The study compares two treatments: Online Guided Self-Help Family-Based Treatment (GSH-FBT) and traditional FBT via Videoconferencing (FBT-V). It aims to determine if GSH-FBT can more efficiently improve clinical outcomes in adolescents with Anorexia Nervosa than FBT-V.
What are the potential side effects?
Since the interventions involve psychological therapy rather than medication, typical medical side effects are not expected. However, participants may experience emotional or psychological discomfort as they confront issues related to their eating disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ratio of therapist hours to %EBW change
Secondary study objectives
Beck Anxiety Inventory (BAI)
Mental Depression
Eating Disorders
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Online Guided Self-Help-Family-based Treatment (GSH-FBT)Experimental Treatment1 Intervention
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 II: FBT via Videoconferencing (FBT-V)Active Control1 Intervention
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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,933 Total Patients Enrolled
55 Trials studying Eating Disorders
23,567 Patients Enrolled for Eating Disorders
Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,740 Total Patients Enrolled
16 Trials studying Eating Disorders
6,511 Patients Enrolled for Eating Disorders
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 12 and 18 years old.I have a condition like diabetes or am pregnant, affecting my eating or weight.I live with my family, which may include just one parent.My body weight is above 75% of the expected for my height and age.I do not have a mental illness that would prevent me from participating in psychotherapy.I am taking medication for a mental health condition.I have been diagnosed with anorexia nervosa.My body weight is within 75% to 88% of the expected range for my height.
Research Study Groups:
This trial has the following groups:- Group 1: Online Guided Self-Help-Family-based Treatment (GSH-FBT)
- Group 2: FBT via Videoconferencing (FBT-V)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Eating Disorders Patient Testimony for trial: Trial Name: NCT05563649 — N/A
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