Anorexia NervosaOPTEDNCT05389657
Optimizing Provider Training in Eating Disorders (OPTED)
A study testing Web-based training and Live training in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Atypical Anorexia Nervosa
- What is being tested?
- Web-based training and Live training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 3 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mental health provider licensed to practice in the state of California, or unlicensed mental health providers in California who are formally employed by their agency/clinic and have a licensed clinical supervisor who agrees to take legal responsibility for any cases treated with FBT
- Must treat patients with Medicaid insurance in a participating county
Who cannot join
- Students (practicum students, interns, externs) or other learners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94103
About this study
Official title: Dissemination and Implementation of Family-Based Treatment in Publicly-Funded Clinics: Optimizing Provider Training in Eating Disorders (OPTED)
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.
Read the detailed description
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders. Clinicians who treat youth and accept Medicaid insurance within a predetermined group of participating California counties will be randomized to receive either online training or live two-day training in FBT. Data will be collected on the feasibility, acceptability, appropriateness, and effectiveness of the training (online vs. live). Following training, a subset of clinicians may opt into group consultation for one year. Consultation groups will be kept separate by training condition. Data will also be collected from clinicians on the extent to which they perceive the treatment itself (i.e., FBT) as feasible, acceptable, and appropriate for Medicaid-insured youth. In addition to implementation outcomes, de-identified clinical data will be collected from providers about their cases up to one year following the initial training.
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Being tested
- Web-based training, Live training
- Keywords
- Training, Eating disorders, Family based treatment, Medicaid, Community mental health, Children and adolescents, Mental health clinicians
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based trainingBehavioural
Web-based training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources.
Live trainingBehavioural
The live training will be delivered by two trainers over the course of two days via Zoom.
| Study group | Role | What they receive |
|---|---|---|
| Web-based training | Experimental | Web-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model. Receives: Behavioral: Web-based training |
| Live training | Active comparator | Live training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model. Receives: Behavioral: Live training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Training
Training completion will be the number of participants who complete the full course of training.
Measured: Post-training (measured at the time of planned completion, which will be 10 weeks from the start of web-based training, or on the second day of live training)
Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training
The FBT Knowledge Assessment (FBT-KA) is an 28-item multiple-choice test that measures knowledge about FBT. Scores range from 0 to 28, with higher scores indicating more knowledge.
Measured: Baseline and post-training (measured immediately following completion of training)
Secondary outcomes (1)
Number of Participants Who Receive FBT Consultation at 12 Months
Providers will report on their receipt (yes/no) of FBT-specific consultation in the 12 months following completion of training.
Measured: 12-month follow-up (measured at 12 months from the deadline for completion of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start14 Jul 2022
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Erin C Accurso, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389657
- Sponsor's protocol ID
- 5K23MH120347
- Other IDs
- 5K23MH120347
- Acronym
- OPTED
- Status last verified
- Jul 2025
- First submitted
- 18 May 2022
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of Family-Based Treatment in Publicly-Funded Clinics: Optimizing Provider Training in Eating Disorders (OPTED)
- ClinicalTrials.gov ID
- NCT05389657
- Acronym / sponsor ID
- OPTED / 5K23MH120347
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Keywords
- Training, Eating disorders, Family based treatment, Medicaid, Community mental health, Children and adolescents, Mental health clinicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders.
Detailed description
This is a randomized controlled trial for mental health clinicians comparing two methods of training in family-based treatment (FBT) for restrictive eating disorders. Clinicians who treat youth and accept Medicaid insurance within a predetermined group of participating California counties will be randomized to receive either online training or live two-day training in FBT. Data will be collected on the feasibility, acceptability, appropriateness, and effectiveness of the training (online vs. live). Following training, a subset of clinicians may opt into group consultation for one year. Consultation groups will be kept separate by training condition. Data will also be collected from clinicians on the extent to which they perceive the treatment itself (i.e., FBT) as feasible, acceptable, and appropriate for Medicaid-insured youth. In addition to implementation outcomes, de-identified clinical data will be collected from providers about their cases up to one year following the initial training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based training | Experimental | Behavioral: Web-based trainingWeb-based training will provide online training primarily focused on family-based treatment and appropriate adaptations to the treatment model. |
| Live training | Active comparator | Behavioral: Live trainingLive training will include two days of expert-led live training (via zoom). The content of the training will be similar to that provided in web-based training, primarily focused on family-based treatment and appropriate adaptations to the treatment model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mental health provider licensed to practice in the state of California, or unlicensed mental health providers in California who are formally employed by their agency/clinic and have a licensed clinical supervisor who agrees to take legal responsibility for any cases treated with FBT
- Must treat patients with Medicaid insurance in a participating county
Key exclusion criteria (1 listed)
- Students (practicum students, interns, externs) or other learners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based trainingWeb-based training will be divided into training modules that will be completed by participants over the course of 6-8 weeks. Training will include didactic training videos, knowledge checks, example sessions, and a library of resources. | Behavioural | Web-based training |
| Live trainingThe live training will be delivered by two trainers over the course of two days via Zoom. | Behavioural | Live training |
Primary outcome
Number of Participants Who Complete Training
Time frame: Post-training (measured at the time of planned completion, which will be 10 weeks from the start of web-based training, or on the second day of live training)
Training completion will be the number of participants who complete the full course of training.
Family-Based Treatment Knowledge Assessment (FBT-KA) Score at Post-Training
Time frame: Baseline and post-training (measured immediately following completion of training)
The FBT Knowledge Assessment (FBT-KA) is an 28-item multiple-choice test that measures knowledge about FBT. Scores range from 0 to 28, with higher scores indicating more knowledge.
1 secondary outcome
Number of Participants Who Receive FBT Consultation at 12 Months
Time frame: 12-month follow-up (measured at 12 months from the deadline for completion of training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin C Accurso, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based training and Live training in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by University of California, San Francisco at 1 site 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 2 inclusion and 1 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 7 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 1 site 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 7 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?
Number of Participants Who Complete Training (time frame: Post-training (measured at the time of planned completion, which will be 10 weeks from the start of web-based training, or on the second day of live training)). 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?
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 7 Aug 2025.