Online Guided Self-Help for Anorexia

Recruiting at 1 trial location

Overseen By Hazal Y Gurcan, B.A.

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Online Guided Self-Help Family-Based Treatment for Anorexia?

Research shows that Family-Based Treatment (FBT) is effective for adolescent anorexia nervosa, and adapting it to online formats like guided self-help (GSH-FBT) and videoconferencing (FBT-V) is feasible and acceptable for families. These online versions help increase access to treatment, especially when in-person options are limited. ^{1 2 3 4 5}

Is online guided self-help family-based treatment for anorexia safe?

The studies primarily focus on the feasibility and acceptability of online guided self-help family-based treatment for anorexia, but they do not report any specific safety concerns, suggesting it is generally safe for use. ^{1 2 4 5 6}

How is the Online Guided Self-Help Family-Based Treatment (GSH-FBT) for anorexia different from other treatments?

The Online Guided Self-Help Family-Based Treatment (GSH-FBT) for anorexia is unique because it allows families to access evidence-based therapy remotely, making it more accessible for those who cannot attend in-person sessions. It involves parents actively participating in their child's treatment through guided self-help, which is supported by trainee psychologists, and is delivered online, offering flexibility and convenience. ^{1 2 3 4 5}

Eligibility Criteria

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

I am between 12 and 18 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Parental guided self-help family based treatment for adolescents with anorexia nervosa: A feasibility study. [2018]

2. United States 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. [2022]

3. England 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. [2022]

4. England 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. [2022]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Utilizing Telehealth to deliver family-based treatment for adolescent anorexia nervosa. [2018]