DepressionNCT03515226

Remote Training in Evidence-based Practices for Clinicians Who Work With Migrant Workers

A study testing ITS based training and Traditional Training in people with Depression, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: ITS based training and Traditional Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 30 Jun 2018to 30 Aug 2020
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

BA level social work student
Bilingual Spanish Speaking

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington Department of Psychiatry and Behavioral Sciences
Seattle, Washington, 98105

Other trials in United States

About this study

This study will compare training as usual to automated training using an intelligent tutoring system in training bachelors (BA) level social workers in cognitive behavioral therapy (CBT). The purpose of the study is to determine if time and cost of training front line clinicians in evidence-based treatments can be shortened, and if this new training model can reduce the need for clinicians to seek advice from experts.

Read the detailed description

The University of Washington (UW) School of Social Work, in partnership with Heritage University's School of Social Work in Yakima Valley recently partnered to develop a training program for bachelors (BA) level Social Workers to address limited clinician capacity in rural primary care settings. Currently the curriculum is a combination of didactic training in telephone based cognitive behavioral therapy (CBT; 20 hours), role play training (25 hours), and guided supervision. The scalability of these programs is limited, however, by expert time to conduct training activities, clinician time away from work to engage in training activities, and the fact that even when clinicians participate in training, there is no guarantee they will certify. Adaptive learning, an educational method that uses adaptive algorithms to may be a potential solution to these problems in capacity building. These programs can tailor the educational experience to the needs of the trainee, reduce time in training, improve competence in complex decision-making and standardize training. This study builds on the existing research base on clinical training, and adds to it by designing and testing an intelligent tutoring system (ITS) based on adaptive learning algorithms. Both CBT experts (Aisenberg) and past CBT trainees (Heritage University School of Social Work) will partner with experts in educational software development (Popovic) to create the ITS, which will be compared to training as usual on time to training, competence and skill drift. The investigators hypothesize that capacity building through improved learnability (target mechanism) will result in enhanced clinical ability to deliver CBT elements competently, and in a shorter time-period, and that greater competence will result in better quality of care.

Conditions: Depression
Being tested: ITS based training, Traditional Training
Keywords: workforce development, intelligent tutoring systems
Medical subject headings: Depression

What participants receive

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

ITS based trainingBehavioural
Training using computerized adaptive training in addition to role play
Traditional TrainingBehavioural
Training using didactics and role plays

Study groups in NCT03515226
Study group	Role	What they receive
Traditional Training	Active comparator	20 hours of didactic education and training in CBT principles, depression assessment and cultural competency and 25 hours in dyad role playing of CBT manualized treatment sessions with supervision. Receives: Behavioral: Traditional Training
ITS based training	Experimental	Traditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies. Receives: Behavioral: ITS based training

What is being measured

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

Acceptability of Intervention Measure (AIM) - Goal Setting
This is a four item measure of intervention acceptability; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill acceptable to use after they complete the training. We administered the AIM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Acceptability of Intervention Measure (AIM) - Identifying Challenges
This is a four item measure of intervention acceptability; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill acceptable to use after they complete the training. We administered the AIM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Intervention Appropriateness Measure (IAM) - Goal Setting
This is a four item measure of intervention appropriateness; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total range for this measure is 4-20. Each group will be compared on the degree they find the specific clinical skill appropriate to use after they complete the training. We administered the IAM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Intervention Appropriateness Measure (IAM) - Identifying Challenges
This is a four item measure of intervention appropriateness; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill appropriate to use after they complete the training. We administered the IAM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Feasibility of Intervention Measure (FIM) - Goal Setting
This is a four item measure of intervention feasibility; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill feasible to use after they complete the training they participated in. We administered the FIM twice asking the students to respond to the feasibility of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Feasibility of Intervention Measure - Identifying Challenges
This is a four item measure of intervention feasibility; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill feasible to use after they complete the training they participated in. We administered the FIM twice asking the students to respond to the feasibility of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Intervention Usability Scale (IUS) - Goal Setting
The IUS is a 10-item measure with a possible total score ranging from 0 to 100; higher scores indicate a more usable intervention. Although this measure has not yet been normed as a measure of intervention usability, the System Usability Scale upon which the IUS is based defines scores of 70 or above as indicative of acceptable usability.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.
Intervention Usability Scale (IUS) - Identifying Challenges
The IUS is a 10-item measure with a possible total score ranging from 0 to 100; higher scores indicate a more usable intervention. Although this measure has not yet been normed as a measure of intervention usability, the System Usability Scale upon which the IUS is based defines scores of 70 or above as indicative of acceptable usability.
Measured: This measure will be administered to participants in each training group after they complete the 25 hours of training.

Timeline

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

30 Jun 201830 Aug 2020

First posted3 May 2018
Study start30 Jun 2018
Primary completion30 Jun 2020
Study completion30 Aug 2020

Why it stopped: Challenges in recruiting eligible participants

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe 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
Model description: Randomized clinical trial
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03515226
Sponsor's protocol ID: STUDY00004268
Other IDs: 1P50MH115837-01
Status last verified: Jul 2022
First submitted: 15 Mar 2018
Last updated: 26 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will be creating a register of study outcomes for all projects under the UW ALACRITY center that researchers and request permission to access.

Publications

Lyon AR, Munson SA, Renn BN, Atkins DC, Pullmann MD, Friedman E, Arean PA. Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability . JMIR Res Protoc. 2019 Oct 9;8(10):e14990. doi: 10.2196/14990.
PubMed 31599736

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remote Training in Evidence-based Practices for Clinicians Who Work With Migrant Workers
ClinicalTrials.gov ID: NCT03515226
Acronym / sponsor ID: STUDY00004268
Conditions: Depression
Keywords: workforce development, intelligent tutoring systems
Study type: Interventional
Recruitment status: TerminatedReason stopped: Challenges in recruiting eligible participants
Enrolment: 25 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 30 Jun 2018 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Aug 2020 (actual)
First posted: 3 May 2018 (actual)
Results: Posted 1 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized clinical trial

Arm	Type	Receives
Traditional Training	Active comparator	Behavioral: Traditional Training20 hours of didactic education and training in CBT principles, depression assessment and cultural competency and 25 hours in dyad role playing of CBT manualized treatment sessions with supervision.
ITS based training	Experimental	Behavioral: ITS based trainingTraditional training plus the addition of an algorithmic based training computer program that trains clinicians in clinical micro-competencies.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

BA level social work student
Bilingual Spanish Speaking

Key exclusion criteria (1 listed)

none

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
ITS based trainingTraining using computerized adaptive training in addition to role play	Behavioural	ITS based training
Traditional TrainingTraining using didactics and role plays	Behavioural	Traditional Training

Primary outcome

Acceptability of Intervention Measure (AIM) - Goal Setting
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention acceptability; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill acceptable to use after they complete the training. We administered the AIM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Acceptability of Intervention Measure (AIM) - Identifying Challenges
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention acceptability; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill acceptable to use after they complete the training. We administered the AIM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Intervention Appropriateness Measure (IAM) - Goal Setting
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention appropriateness; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total range for this measure is 4-20. Each group will be compared on the degree they find the specific clinical skill appropriate to use after they complete the training. We administered the IAM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Intervention Appropriateness Measure (IAM) - Identifying Challenges
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention appropriateness; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill appropriate to use after they complete the training. We administered the IAM twice asking the students to respond to the acceptability of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Feasibility of Intervention Measure (FIM) - Goal Setting
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention feasibility; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill feasible to use after they complete the training they participated in. We administered the FIM twice asking the students to respond to the feasibility of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on goal setting.
Feasibility of Intervention Measure - Identifying Challenges
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
This is a four item measure of intervention feasibility; where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate. The total scale range is 4-20. Each group will be compared on the degree they find the specific clinical skill feasible to use after they complete the training they participated in. We administered the FIM twice asking the students to respond to the feasibility of goal setting as a clinical skill and of identifying challenges as a clinical skill. This section reports on identifying challenges.
Intervention Usability Scale (IUS) - Goal Setting
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
The IUS is a 10-item measure with a possible total score ranging from 0 to 100; higher scores indicate a more usable intervention. Although this measure has not yet been normed as a measure of intervention usability, the System Usability Scale upon which the IUS is based defines scores of 70 or above as indicative of acceptable usability.
Intervention Usability Scale (IUS) - Identifying Challenges
Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.
The IUS is a 10-item measure with a possible total score ranging from 0 to 100; higher scores indicate a more usable intervention. Although this measure has not yet been normed as a measure of intervention usability, the System Usability Scale upon which the IUS is based defines scores of 70 or above as indicative of acceptable usability.

Results and safety

Results posted to the registry on 1 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Traditional Training	10	8
ITS Based Training	15	11

Primary outcome: Acceptability of Intervention Measure (AIM) - Goal Setting

Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.. Mean (Standard Deviation). Unit: score on a scale

Measure	Traditional Training n = 8	ITS Based Training n = 11
Pre-Training	17.88 (0.99)	17.64 (1.43)
Post-Training	17.63 (1.69)	18.27 (2.61)

Primary outcome: Acceptability of Intervention Measure (AIM) - Identifying Challenges

Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.. Mean (Standard Deviation). Unit: score on a scale

Measure	Traditional Training n = 8	ITS Based Training n = 11
Pre-Training	16.75 (1.39)	17.73 (3.44)
Post-Training	16.25 (1.28)	17.82 (1.72)

Primary outcome: Intervention Appropriateness Measure (IAM) - Goal Setting

Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.. Mean (Standard Deviation). Unit: score on a scale

Measure	Traditional Training n = 8	ITS Based Training n = 11
Pre-Training	18.25 (1.75)	18.55 (1.63)
Post-Training	17.88 (2.23)	18.82 (1.54)

Primary outcome: Intervention Appropriateness Measure (IAM) - Identifying Challenges

Time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.. Mean (Standard Deviation). Unit: score on a scale

Measure	Traditional Training n = 8	ITS Based Training n = 11
Pre-Training	16.38 (1.19)	18.82 (2.27)
Post-Training	17.13 (1.81)	18.27 (1.90)

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Traditional Training	0 of 8 (0%)	0 of 8 (0%)	0 of 8
ITS Based Training	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31599736Lyon AR, Munson SA, Renn BN, Atkins DC, Pullmann MD, Friedman E, Arean PA. Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability . JMIR Res Protoc. 2019 Oct 9;8(10):e14990. doi: 10.2196/14990.
Individual participant dataSharing planned: Yes. We will be creating a register of study outcomes for all projects under the UW ALACRITY center that researchers and request permission to access.

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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.

Patricia Arean principal investigator

UWMC Psychiatry

Brenna Renn, PhD study director

UWMC Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ITS based training and Traditional Training in people with Depression, run by University of Washington 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: stopped early, as of the sponsor's last update on 26 Jul 2022. 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 1 Dec 2021). 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?

Acceptability of Intervention Measure (AIM) - Goal Setting (time frame: This measure will be administered to participants in each training group after they complete the 25 hours of training.). The study lists 8 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 NCT03515226, 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 26 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.