Online Guided Self-Help for Anorexia

Recruiting at 1 trial location

Overseen By Ainsley E Cogburn, B.S.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Psychotic illness, Intellectual disability, Drug dependence, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 9 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for families to treat anorexia: a guided self-help program called Online Guided Self-Help Family-Based Treatment and a therapist-led approach via videoconferencing, known as FBT via Videoconferencing. The researchers aim to determine if the self-help method can match the effectiveness of traditional therapy while requiring less time and fewer resources. Participants should be teens aged 12-18 diagnosed with anorexia, living with family, and have internet and computer access. The trial seeks to make anorexia treatment more accessible and efficient for families. As an unphased trial, it offers families the chance to explore innovative treatment methods that could simplify and enhance anorexia care.

Will I have to stop taking my current medications?

The trial allows participants to continue taking medications for other psychiatric disorders, so you likely won't need to stop your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Online Guided Self-Help Family-Based Treatment (GSH-FBT) and Family-Based Treatment via Videoconferencing (FBT-V) are generally safe and well-tolerated for treating teenagers with anorexia nervosa.

Studies have demonstrated that Family-Based Treatment (FBT), which forms the basis for both GSH-FBT and FBT-V, effectively treats anorexia in teens. Early evidence suggests that FBT is safe when delivered online. Additionally, a study conducted at multiple sites found that both GSH-FBT and FBT-V are safe and acceptable to participants, meaning people usually do not experience serious side effects.

Overall, these treatments have been successfully used in different settings, indicating they are safe and a good option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for anorexia because they offer more flexible and accessible options for families. The Online Guided Self-Help-Family-based Treatment (GSH-FBT) empowers parents with a structured online curriculum and video resources, allowing them to support their child’s recovery at their own pace, with guidance from a trained "coach." This contrasts with traditional in-person therapy, which can be more time-consuming and less accessible. Meanwhile, Family-Based Treatment via Videoconferencing (FBT-V) adapts the traditional face-to-face sessions into a virtual format, making it easier for families to participate from the comfort of their home while maintaining the crucial therapist-led support. These innovative approaches aim to make effective treatment more accessible, especially for those who may face barriers to in-person care.

What evidence suggests that this trial's treatments could be effective for Anorexia?

Research has shown that Family-Based Treatment (FBT) effectively treats teenagers with anorexia nervosa. Studies have found that FBT can be successfully delivered through telehealth, offering convenience without compromising effectiveness. In this trial, participants will be randomized to receive either Online Guided Self-Help Family-Based Treatment (GSH-FBT) or FBT via Videoconferencing (FBT-V). Early results for GSH-FBT suggest it might provide similar benefits to traditional FBT, with added accessibility and flexibility. Both in-person and online GSH treatments for eating disorders have demonstrated promising results. Thus, GSH-FBT could be a suitable option for those seeking flexible treatment that still offers strong support and guidance. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I live with my family, which may include just one parent.

Exclusion Criteria

Inability of the participant and/or family to speak and understand English

I have a condition like diabetes or am pregnant, affecting my eating or weight.

Previous FBT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GSH-FBT or FBT-V treatment. GSH-FBT consists of 10 parent-only sessions over 9 months, while FBT-V includes 15 sessions over 9 months.

9 months

10 sessions (GSH-FBT), 15 sessions (FBT-V)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months post-treatment.

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• FBT via Videoconferencing
• Online Guided Self-Help-Family-based Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Online Guided Self-Help-Family-based Treatment (GSH-FBT) Experimental Treatment 1 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 Control 1 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.

FBT via Videoconferencing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Family-Based Treatment for:

• Anorexia Nervosa in adolescents

Approved in European Union as Family-Based Treatment for:

• Anorexia Nervosa in adolescents

Approved in Canada as Family-Based Treatment for:

• Anorexia Nervosa in adolescents

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The online guided self-help family-based treatment (GSH-FBT) for families waiting for face-to-face treatment showed promising results, with participating children gaining an average of 6 kg and experiencing a significant decrease in eating disorder behaviors.

Parents reported enhanced knowledge, skills, and confidence in managing their child's anorexia nervosa, indicating that GSH-FBT can be a valuable interim support, although strategies to improve initial recruitment are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is guided self-help family-based treatment for parents of adolescents with anorexia nervosa on treatment waitlists feasible? A pilot trial. Wade, T., Byrne, S., Fursland, A., et al.[2022]

Guided self-help (GSH) for eating disorders is a promising treatment option, especially for children and adolescents, where access to traditional therapies is often limited.

This study provides detailed insights into online GSH sessions, highlighting how they differ from standard family-based therapy (FBT) delivered via videoconferencing, which could enhance understanding and implementation of these methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying online parental guided self-help family-based treatment for adolescent anorexia nervosa: A comparison to family-based treatment delivered by videoconferencing. Couturier, J., Webb, C., Carson, N., et al.[2022]

Family-based treatment (FBT) for adolescents with anorexia nervosa delivered via a Telehealth platform was found to be feasible, with all 10 participants successfully recruited and retained throughout the study.

Significant improvements in weight gain, as measured by percent median body mass index (%mBMI), were observed from baseline to the end of treatment and maintained at a 6-month follow-up, indicating the effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Telehealth to deliver family-based treatment for adolescent anorexia nervosa. Anderson, KE., Byrne, CE., Crosby, RD., et al.[2018]

A pilot study involving 40 adolescents with anorexia nervosa showed that both the online guided self-help program for parents (GSH-FBT) and videoconferencing family-based treatment (FBT-V) were similarly acceptable and effective in improving weight and parental self-efficacy, with significant improvements maintained at a 3-month follow-up.

GSH-FBT demonstrated a greater efficiency in achieving treatment outcomes compared to FBT-V, suggesting that online interventions may be a more time-effective option for families dealing with anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of conducting a randomized controlled trial comparing family-based treatment via videoconferencing and online guided self-help family-based treatment for adolescent anorexia nervosa. Lock, J., Couturier, J., Matheson, BE., et al.[2021]

Families and treatment teams generally found Family-Based Treatment delivered via videoconferencing (FBT-V) to be acceptable and feasible, highlighting benefits like increased patient access and convenience.

Challenges included technical difficulties and distractions at home, with families suggesting a hybrid model that combines both in-person and virtual sessions for better therapeutic rapport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative evaluation of team and family perceptions of family-based treatment delivered by videoconferencing (FBT-V) for adolescent Anorexia Nervosa during the COVID-19 pandemic. Couturier, J., Pellegrini, D., Grennan, L., et al.[2022]

A parental guided self-help version of family-based treatment (FBT) for adolescent anorexia nervosa was found to be feasible and acceptable, with 19 families participating in the study over 6 months.

Participants showed significant improvements in weight, with median BMI increasing from 85.01% to 97.31%, and reductions in eating-related psychopathology, indicating potential effectiveness of this self-help approach, although further evaluation is needed due to a high dropout rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental guided self-help family based treatment for adolescents with anorexia nervosa: A feasibility study. Lock, J., Darcy, A., Fitzpatrick, KK., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661034/

Delivering evidence-based treatment via telehealth for ... This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of telehealth-FBT delivered by community-based clinicians within rural ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3038846/

RANDOMIZED CLINICAL TRIAL COMPARING FAMILY ... Objective. To evaluate the relative efficacy of family-based treatment (FBT) and adolescent focused individual therapy (AFT) for adolescents with anorexia ...

3. fbt-fiat.de fbt-fiat.de/files/Download/Publikation/Intl%20J%20Eating%20Disorders%20-%202025%20-%20Drury%20-%20Comparing%20Outcomes%20for%20Telehealth%20Versus%20In%E2%80%90Person%20Family%E2%80%90Based%20Treatment%20%20A.pdf

Comparing Outcomes for Telehealth Versus In‐Person ... (2015, 2017) first examined the feasibility and effectiveness of telehealth FBT in 10 adolescents with anorexia nervosa (AN) and atypical AN.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002015

Protocol for a randomized clinical trial to confirm the ... Further, a multisite randomized pilot study comparing online GSH-FBT to FBT-V [19] found that both treatments were safe to deliver and similarly acceptable to ...

5. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00879-9

Effects of family-based treatment on adolescent outpatients ... FBT for AN appeared to be an effective and sometimes sufficient intervention, especially for patients with milder weight deficit and less severe psychiatric ...

6. mdpi.com mdpi.com/2072-6643/17/13/2160

Advancements in Family-Based Treatment of Adolescent ... This review provides a literature update on studies reporting the real-world access challenges for FBT, with particular attention paid to non-research settings.

7. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-025-01272-4

Family-based treatment with metacognitive therapy for ... We tested whether metacognitive therapy, combined with FBT, is effective, tolerable, and safe for adolescents with AN and their parents.