- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07707102
Advancing Skills Through Consultation, Education, and Novel Technologies (ASCENT)
Increasing the Reach of Evidence-Based PTSD Treatment: Development and Clinical Trial of Artificial Intelligence (AI)-Facilitated, Web-Based Written Exposure Therapy Training
This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD). There are a number of evidence-based treatments for posttraumatic stress disorder (PTSD). However, most behavioral health providers have not received training in these PTSD treatments and do not offer them regularly to their patients.
The researchers hope to learn about the optimal way to train behavioral providers in this type of treatment. This study is designed to determine the comparative effectiveness of different training strategies on key outcomes such as how much competency providers develop in the therapy and to how many patients they deliver the therapy. This study will help the researchers understand if we can help more providers learn to competently delivery Written Exposure Therapy by using strategies that are more convenient and cost less money, including web-based and AI-facilitated training supports. This study will also help us learn which training strategies work best for which providers so that in the future we can make personalized training recommendations.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study will enroll behavioral health providers (i.e., professional therapists) and test a training program for Written Exposure Therapy that includes
- an enhanced, web-based foundational training (web-based training plus integrated TherapyTrainer components) and
- an AI training support tool for competency development (TherapyTrainer).
This randomized clinical trial will compare web/AI training, among providers who serve Veterans and Service Members, to standard Written Exposure Therapy training (i.e., human-delivered live workshop and consultation calls) on provider, patient, and cost-effectiveness outcomes. There is no cross-over of conditions. Providers in both conditions will be eligible to earn continuing education credits and approval as Written Exposure Therapy Providers who have completed competency based training and two training cases.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Stefanie Losavio, PhD
- Telefonnummer: (210) 562-6714
- E-mail: ASCENT@uthscsa.edu
Studiesteder
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center at San Antonio
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Kontakt:
- Stefanie LoSavio, PhD
- Telefonnummer: (210) 562-6714
- E-mail: losavio@uthscsa.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- mental health provider;
- serves veterans and/or service members with PTSD (by self-report);
- willing to participate in either live or web-based training.
Exclusion Criteria:
1. has already completed formal training in Written Exposure Therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Workshop + Consultation Calls
10-hour, live workshop over 2 days with a live trainer via video conferencing.
There will also be twelve 1 hour calls with a live therapy consultant .
|
Approximately 10 hours (excluding breaks) over 2 days with a live trainer via video conferencing (e.g., Zoom)
Twelve 1-hour calls with a live therapy consultant via videoconferencing (e.g., Zoom)
|
|
Aktiv komparator: Workshop + TherapyTrainer
10-hour, live workshop over 2 days with a live trainer via video conferencing.There will also be approximately 12 hours of engagement with the AI training support tool (TherapyTrainer)
|
Approximately 10 hours (excluding breaks) over 2 days with a live trainer via video conferencing (e.g., Zoom)
No live meetings, but approximately 12 hours of engaging with the AI training support tool (TherapyTrainer)
Andre navne:
|
|
Aktiv komparator: Web-Based Training + Consultation Calls
AI enhanced Web-based training with no live meetings, but approximately 8-10 hours of asynchronous, self-paced training.
There will also be twelve 1 hour calls with a live therapy consultant .
|
Twelve 1-hour calls with a live therapy consultant via videoconferencing (e.g., Zoom)
No live meetings, but approximately 8-10 hours of asynchronous training at the learner's pace over about 1 month.
|
|
Aktiv komparator: Web-based Training + TherapyTrainer
AI enhanced Web-based training with no live meetings, but approximately 8-10 hours of asynchronous, self-paced training.
There will also be approximately 12 hours of engagement with the AI training support tool (TherapyTrainer)
|
No live meetings, but approximately 12 hours of engaging with the AI training support tool (TherapyTrainer)
Andre navne:
No live meetings, but approximately 8-10 hours of asynchronous training at the learner's pace over about 1 month.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Provider WET Competency
Tidsramme: Baseline to 7 months
|
A 20-item multiple choice treatment knowledge assessment.
Higher scores indicate greater knowledge of WET.
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Baseline to 7 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Completion of Practice Cases
Tidsramme: 4 months
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Number of participants that complete practice cases
|
4 months
|
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Time to complete Practice Cases
Tidsramme: 4 months
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Number of days to complete two training cases (real or simulated)
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4 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stefanie LoSavio, PhD, The University of Texas Health Science Center at San Antonio
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00002482
- HT9425-25-1-0585 (Andet bevillings-/finansieringsnummer: Department of Defense)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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