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Online Training for TherapistsNCT04428580

Implementing FBT for Adolescent AN for Providers in Private Practice

A study testing Online FBT Training and Webinar FBT Training in people with Online Training for Therapists, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is a critical need to disseminate efficacious psychosocial treatments for mental disorders as there is a significant gap between evidenced-based approaches and common clinical practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Online Training for Therapists
What is being tested?
Online FBT Training and Webinar FBT Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
2 sitesUnited States
Study dates
20 Nov 2020to 1 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Therapists are eligible to participate if they have completed a masters or doctoral training in their field (psychology, psychiatry, family therapy, social work)
  • Licensed in their respective state
  • No reports of malpractice or loss of privileges at relevant clinical institutions
  • Have computer/web access for online training and assessments
  • No previous 2-day in-person workshop training in FBT
  • Submit baseline data on fidelity rating and weight gain from week 1-4 from a previously treated adolescent with AN they have treated in the last 6 months or alternatively one that they treat within 3 months of the initial screening before starting the training.

Who cannot join

  • Therapists who have had previous training in FBT are not eligible.
  • Therapists who are unable to provide baseline data on fidelity rating and weight gain from week 1-4 from a previously treated adolescent with AN they have treated in the last 6 months or alternatively one that they treat within 3 months of the initial screening before starting the training will also be excluded.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of California, San Francisco

    San Francisco, California, 94143

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Implementing Family-Based Treatment for Adolescent Anorexia Nervosa for Providers in Private Practice: A Feasibility Study

There is a critical need to disseminate efficacious psychosocial treatments for mental disorders as there is a significant gap between evidenced-based approaches and common clinical practice. One example of the need to improve dissemination and implementation of psychosocial treatments is for adolescent Anorexia Nervosa (AN), a serious mental disorder with an incidence rate of about 1% that can become life-threatening. Based on outcomes from a series of randomized clinical trials (RCTs), the first-line treatment for adolescent AN is Family-based Treatment (FBT); however, very few therapists are trained to use FBT for AN. Further, while approximately 45-50% of US mental health outpatient providers are in private practice, little attention has been paid to how best to train this group. Care for adolescent AN, in particular, is provided in private practice at high rates, because specialist programs in non-private settings are few and not readily accessible. Motivations, incentives, and rationale for learning evidence-based treatments (EBTs) differ in this group compared to therapists embedded in an organization or health care system. In this application, we propose to use an online training strategy to study the adoption of FBT to better understand factors that limit or enhance uptake and implementation of this treatment in private practice. We developed and piloted a self-directed enhanced online training (ET-FBT) aimed at improving therapist skills and knowledge related to key components of FBT for AN that predict patient outcome in a group of therapists of which 64% were in private practice. We propose to build on these findings to examine the feasibility of new methods to retain therapists during supervision, assess fidelity, and collect patient outcomes from clinicians in private practice. Thus, our specific aims are:

Aim 1: The overall aim of the study is to assess the feasibility of conducting a randomized clinical trial comparing two implementation strategies (online training vs webinar training) for training clinicians in private practice in FBT for AN. We predict that those randomized to online training will be retained, receive supervision, and provide patient data at higher rates than those who receive webinar training.

Read more

Aim 2: Patient outcomes (reflecting therapist effectiveness) will be assessed by comparing patient weight gain from session 1 to 4 of FBT before and after training (target for training effect) and compared between randomized groups. We predict a moderate efficacy signal difference favoring those who are received the online training. because of increased training in key components in the online training program.

Aim 3: Validate training effect by examining the association between therapist fidelity to FBT and patient outcomes. We predict that fidelity will be correlated (target validation) with patient outcome. The effects of therapeutic alliance, participation in supervision, and self-efficacy on both fidelity and patient outcome will be explored.

Aim 4: Explore BL factors associated with implementation processes (e.g. prior training, experience, family work).The primary significance of this study is its potential to increase the availability of FBT--the most effective treatment for adolescent AN. Increased availability of FBT will decrease cost, hospitalization, morbidity, mortality, and chronicity of the disorder.

Being tested
Online FBT Training, Webinar FBT Training
Keywords
FBT, Training, Fidelity, Anorexia, Anorexia Nervosa
Medical subject headings
Anorexia, Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online FBT TrainingOther

    Therapists will receive online training in Family-Based Treatment (FBT)

  • Webinar FBT TrainingOther

    Therapists will receive webinar training in Family-Based Treatment (FBT)

Study groups in NCT04428580
Study groupRoleWhat they receive
Online TrainingExperimental10 lectures that are self-paced with a maximum of three months to complete with each lecture bundle comprising of 5-8 short (about 4 minutes in length), didactic videos that discuss the treatment model and provide mock therapy session video clips (modeling FBT with a typical adolescent AN case), as well as supplementary readings and videotaped role-plays. Enrollees complete each lecture bundle and complete the assignments as they move through the training at their own pace, but to have completed all within the 3-month time frame. When the training is completed, therapists will proceed to schedule post-online supervision for a minimum of 1 case and a maximum of 2 cases over the course of 3 months.
Receives: Other: Online FBT Training
Webinar TrainingActive comparator1-hour weekly webinar lectures that essentially is the FBT training that is conducted in person, just recorded. There will be lectures discussing the scientific evidence supporting FBT, how therapists set up treatment for FBT, main interventions used in FBT during each phase, and recorded role-plays illustrating interventions throughout the 3 phases. Enrollees watch each webinar video as it is released weekly over a 12 week (3 month period). When the training is completed, therapists will proceed to schedule post-online supervision for a minimum of 1 case and a maximum of 2 cases over the course of 3 months.
Receives: Other: Webinar FBT Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment

    Number of recruited subjects who provide full baseline data set at a rate of 50%

    Measured: 1 day (day of baseline assessment)

  2. Retention

    Number of recruited subjects who provide full post training data set at a rate of 50%

    Measured: Week 12 (1 day at end of training)

Secondary outcomes (1)
  1. Exploring Association Between Fidelity and Outcome

    A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4).

    Measured: Baseline and Follow-up (after supervision)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start20 Nov 2020
  3. Primary completion2 Aug 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428580
Sponsor's protocol ID
56548
Other IDs
R34MH123596
Status last verified
Aug 2025
First submitted
6 Jun 2020
Last updated
29 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Citron K, Johnson M, Matheson BE, Onipede ZA, Yang HJ, Bohon C, Le Grange D, Lock J. Study protocol for training providers in private practice in family-based treatment for adolescents with anorexia nervosa: A randomized controlled feasibility trial. Contemp Clin Trials. 2022 Sep;120:106889. doi: 10.1016/j.cct.2022.106889. Epub 2022 Aug 20.

    PubMed 35998767

Questions about this trial

What is this clinical trial studying?

A study testing Online FBT Training and Webinar FBT Training in people with Online Training for Therapists, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (time frame: 1 day (day of baseline assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04428580, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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