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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ratio of therapist hours to %EBW change
Secondary outcome measures
Beck Anxiety Inventory (BAI)
Mental Depression
Eating Disorders
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
2,786 Previous Clinical Trials
2,689,509 Total Patients Enrolled
47 Trials studying Anorexia Nervosa
22,643 Patients Enrolled for Anorexia Nervosa
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,150 Total Patients Enrolled
14 Trials studying Anorexia Nervosa
1,155 Patients Enrolled for Anorexia Nervosa
Media Library
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.
Anorexia Nervosa Patient Testimony for trial: Trial Name: NCT05563649 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is considered an appropriate candidate for this research project?
"The requirements to participate in this trial mandate that candidates must between the ages of 12 and 18. There are 38 trials for people within these age limits, while 33 clinical studies accept applicants who surpass 65 years of age."
Answered by AI
Are researchers currently signing up volunteers for this research project?
"Affirmative. As per the data on clinicaltrials.gov, this medical trial started recruiting participants on January 19th 2023 and is currently still enrolling patients. A total of 200 individuals must be recruited from 2 different sites for study completion."
Answered by AI
Are there any limitations to the number of participants in this experiment?
"Affirmative, clinicaltrials.gov displays that this medical experiment is actively searching for enrollees. It was initially uploaded on January 19th 2023 and its latest update being the 23rd of Januray in the same year. The study necessitates 200 individuals from two sites to complete it."
Answered by AI
What criteria must prospective participants satisfy in order to be enrolled for this research?
"This clinical trial is enrolling 200 adolescents between the ages of 12 and 18 suffering from anorexia nervosa. It is stipulated that those interested must reside with family members who are fluent in English, own a computer with internet access, meet DSM-5 criteria for AN (both subtypes), have an EBW ranging between 75% and 88%, be medically stable as per American Academy of Pediatrics' and Society of Adolescent Medicine's standards, not engage in other psychotherapy trials during or after treatment sessions within this study, while medications taken to treat comorbid psychiatric disorders will be considered; randomization will help balance out groups through"
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Compensation for my condition. I have been struggling to find outpatient care. I have been to multiple residential treatment centers and always do well, until step down. I currently am looking to do of a more FBT approach.
PatientReceived 1 prior treatment
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