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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH123596 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Training | Experimental | 10 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. |
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| Webinar Training | Active Comparator | 1-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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online FBT Training | Other | Therapists will receive online training in Family-Based Treatment (FBT) |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Number of recruited subjects who provide full baseline data set at a rate of 50% | 1 day (day of baseline assessment) |
| Retention | Number of recruited subjects who provide full post training data set at a rate of 50% | Week 12 (1 day at end of training) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploring Association Between Fidelity and Outcome | A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4). | Baseline and Follow-up (after supervision) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Lock, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35998767 | Background | 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. |
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1143 participants started the online screening process and 426 completed screening. 393 who completed the screen had sufficient information included in screening in order to assess eligibility. 151 participants signed informed consent, 123 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Online Training | Therapists receive enhanced online training in Family-Based Treatment (FBT) |
| FG001 | Webinar Training | Therapists will receive online webinar training in Family-Based Treatment (FBT) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Training | Therapists receive enhanced online training in Family-Based Treatment (FBT) |
| BG001 | Webinar Training | Therapists will receive online webinar training in Family-Based Treatment (FBT) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Recruitment | Number of recruited subjects who provide full baseline data set at a rate of 50% | Posted | Count of Participants | Participants | 1 day (day of baseline assessment) |
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Average approximately 6 months (12 weeks of training plus up to 12 weeks for supervision)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online Training | Therapists receive enhanced online training in Family-Based Treatment (FBT) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Lock, MD, PhD | Stanford University | (650) 498-9111 | jimlock@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | Jul 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2020 | Jul 17, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2024 | Jul 17, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001068 | Feeding and Eating Disorders |
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| Webinar FBT Training | Other | Therapists will receive webinar training in Family-Based Treatment (FBT) |
|
| Stanford |
| California |
| 94305 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| Primary | Retention | Number of recruited subjects who provide full post training data set at a rate of 50% | Posted | Count of Participants | Participants | Week 12 (1 day at end of training) |
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| Secondary | Exploring Association Between Fidelity and Outcome | A therapist fidelity questionnaire and reported patient weight outcomes (weight change from FBT session 1 to session 4). | Posted | Count of Participants | Participants | Baseline and Follow-up (after supervision) |
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| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Webinar Training | Therapists will receive online webinar training in Family-Based Treatment (FBT) | 0 | 62 | 0 | 62 | 0 | 62 |
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| D001523 | Mental Disorders |