Motivational InterviewingNCT04558060
Randomized, Controlled Evaluation of a Virtual Human Patient for Provider Training in Motivational Interviewing
A study testing Virtual Standardized Patient and Academic Study in people with Motivational Interviewing, run by VA Puget Sound Health Care System.
Trial summary
The purpose of this study is to evaluate the efficacy of training with a virtual standardized patient on the acquisition and maintenance of motivational interviewing skills compared with traditional academic study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Motivational Interviewing
- What is being tested?
- Virtual Standardized Patient and Academic Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2016to 12 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All health care staff (e.g., physicians, nurses, social workers, psychologists) from supporting service lines are eligible to participate in the study.
Who cannot join
- 8 hours or more of formal training in MI in the year prior to baseline assessment.
- Successfully completed participation in the VA Evidence Based Practice roll-out of MI.
- Served as MI trainers or have conducted research on MI at any time
- Do not anticipate being available for the full duration of the training study (according to their verbal self-report)
About this study
The purpose of this study is to evaluate the efficacy of training with a virtual standardized patient on the acquisition and maintenance of motivational interviewing skills compared with traditional academic study.
Read the detailed description
Motivational interviewing is an evidence-based counseling approach that aims to increase a patient's motivation to make positive health changes in their lives. A common training method for medical professionals is the use of human standardized patients, who are actors who pretend to be patients for educational interviews. Standardized patients are expensive and it is challenging to maintain an adequate pool of patient actors. Accordingly, after licensure or medical boards, health professionals typically adopt new evidence-based practices, like motivational interviewing, without human standardized patient training experiences. Given the established importance of post-training coaching and feedback to the acquisition of motivational interviewing, innovative training methods are needed. Computer virtual patients may provide a cost-effective alternative that is scalable and supports dissemination of evidence-based practices. This study will evaluate the efficacy of a virtual standardized patient, relative to academic study, for training motivational interviewing among health care professionals from the Department of Veterans Affairs and Department of Defense.
- Conditions
- Motivational Interviewing
- Being tested
- Virtual Standardized Patient, Academic Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Standardized PatientOther
Computer program that presented a virtual human patient
Academic StudyOther
Study of a summary of motivational interviewing concepts and techniques.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Standardized Patient | Experimental | Training for 45 minutes at each training time point with a computer program that presented a virtual human patient and two simulated patient encounters. The virtual standardized patient involves a branching story line. Participants select 1 of 3 computer-generated response options at each conversational pause: 1) a response that is consistent with the principles and skills of MI, 2) an MI inconsistent response, or 3) a response that is mixed - partly consistent and partly inconsistent with MI. Receives: Other: Virtual Standardized Patient |
| Academic Study | Active comparator | Study of a summary handout of motivational interviewing concepts and techniques for 45-minutes. Receives: Other: Academic Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Measured: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Measured: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Measured: Change in Motivational Interviewing Treatment Integrity 4.2.1 from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Secondary outcomes (16)
Difference in Helpful Responses Questionnaire between the conditions
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Measured: Change in Helpful Responses Questionnaire from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Measured: Change in Helpful Responses Questionnaire from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Measured: Change in Helpful Responses Questionnaire from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
14-item self-report measure of motivational interviewing self-efficacy
Measured: Change in Motivational Interviewing Self-efficacy Scale from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
14-item self-report measure of motivational interviewing self-efficacy
Measured: Change in Motivational Interviewing Self-efficacy Scale from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
14-item self-report measure of motivational interviewing self-efficacy
Measured: Change in Motivational Interviewing Self-efficacy Scale from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Self-reported 3-item measure of MI working knowledge, skills and confidence
Measured: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to post-training [approximately 2-weeks after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Self-reported 3-item measure of MI working knowledge, skills and confidence
Measured: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Self-reported 3-item measure of MI working knowledge, skills and confidence
Measured: Change in Provider Knowledge, Skills, and Confidence Survey from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Measured: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Measured: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Measured: Change in Motivational Interviewing Knowledge and Attitudes Test from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Objective, 18-item multiple choice test of motivational interviewing knowledge
Measured: Change in Motivational Knowledge Test-Revised from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Objective, 18-item multiple choice test of motivational interviewing knowledge
Measured: Change in Motivational Knowledge Test-Revised from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Objective, 18-item multiple choice test of motivational interviewing knowledge
Measured: Change in Motivational Knowledge Test-Revised from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Training Satisfaction Survey between the conditions
An 11-item satisfaction survey that assesses participants' satisfaction with the training provided and the degree to which the training enhanced their abilities and preparedness to use MI.
Measured: Post-training [approximately 2-weeks after baseline]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start17 Oct 2016
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Greg Reger, VA Puget Sound Health Care System
- Investigators
- Greg Reger, PhD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558060
- Sponsor's protocol ID
- DM150015
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reger GM, Norr AM, Rizzo AS, Sylvers P, Peltan J, Fischer D, Trimmer M, Porter S, Gant P, Baer JS. Virtual Standardized Patients vs Academic Training for Learning Motivational Interviewing Skills in the US Department of Veterans Affairs and the US Military: A Randomized Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2017348. doi: 10.1001/jamanetworkopen.2020.17348.
PubMed 33057643
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Evaluation of a Virtual Human Patient for Provider Training in Motivational Interviewing
- ClinicalTrials.gov ID
- NCT04558060
- Acronym / sponsor ID
- DM150015
- Conditions
- Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of training with a virtual standardized patient on the acquisition and maintenance of motivational interviewing skills compared with traditional academic study.
Detailed description
Motivational interviewing is an evidence-based counseling approach that aims to increase a patient's motivation to make positive health changes in their lives. A common training method for medical professionals is the use of human standardized patients, who are actors who pretend to be patients for educational interviews. Standardized patients are expensive and it is challenging to maintain an adequate pool of patient actors. Accordingly, after licensure or medical boards, health professionals typically adopt new evidence-based practices, like motivational interviewing, without human standardized patient training experiences. Given the established importance of post-training coaching and feedback to the acquisition of motivational interviewing, innovative training methods are needed. Computer virtual patients may provide a cost-effective alternative that is scalable and supports dissemination of evidence-based practices. This study will evaluate the efficacy of a virtual standardized patient, relative to academic study, for training motivational interviewing among health care professionals from the Department of Veterans Affairs and Department of Defense.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Standardized Patient | Experimental | Other: Virtual Standardized PatientTraining for 45 minutes at each training time point with a computer program that presented a virtual human patient and two simulated patient encounters. The virtual standardized patient involves a branching story line. Participants select 1 of 3 computer-generated response options at each conversational pause: 1) a response that is consistent with the principles and skills of MI, 2) an MI inconsistent response, or 3) a response that is mixed - partly consistent and partly inconsistent with MI. |
| Academic Study | Active comparator | Other: Academic StudyStudy of a summary handout of motivational interviewing concepts and techniques for 45-minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All health care staff (e.g., physicians, nurses, social workers, psychologists) from supporting service lines are eligible to participate in the study.
Key exclusion criteria (4 listed)
- 8 hours or more of formal training in MI in the year prior to baseline assessment.
- Successfully completed participation in the VA Evidence Based Practice roll-out of MI.
- Served as MI trainers or have conducted research on MI at any time
- Do not anticipate being available for the full duration of the training study (according to their verbal self-report)
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 |
|---|---|---|
| Virtual Standardized PatientComputer program that presented a virtual human patient | Other | Virtual Standardized Patient |
| Academic StudyStudy of a summary of motivational interviewing concepts and techniques. | Other | Academic Study |
Primary outcome
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to post-training [approximately 2-weeks after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
16 secondary outcomes
Difference in Helpful Responses Questionnaire between the conditions
Time frame: Change in Helpful Responses Questionnaire from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Time frame: Change in Helpful Responses Questionnaire from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Time frame: Change in Helpful Responses Questionnaire from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time frame: Change in Motivational Interviewing Self-efficacy Scale from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time frame: Change in Motivational Interviewing Self-efficacy Scale from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time frame: Change in Motivational Interviewing Self-efficacy Scale from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time frame: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to post-training [approximately 2-weeks after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time frame: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time frame: Change in Provider Knowledge, Skills, and Confidence Survey from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time frame: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time frame: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time frame: Change in Motivational Interviewing Knowledge and Attitudes Test from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time frame: Change in Motivational Knowledge Test-Revised from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time frame: Change in Motivational Knowledge Test-Revised from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time frame: Change in Motivational Knowledge Test-Revised from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Training Satisfaction Survey between the conditions
Time frame: Post-training [approximately 2-weeks after baseline]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Derived from this study: PubMed 33057643Reger GM, Norr AM, Rizzo AS, Sylvers P, Peltan J, Fischer D, Trimmer M, Porter S, Gant P, Baer JS. Virtual Standardized Patients vs Academic Training for Learning Motivational Interviewing Skills in the US Department of Veterans Affairs and the US Military: A Randomized Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2017348. doi: 10.1001/jamanetworkopen.2020.17348.
- 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.
Greg Reger, PhD principal investigator
VA Puget Sound Health Care System
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Standardized Patient and Academic Study in people with Motivational Interviewing, run by VA Puget Sound Health Care System.
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 1 inclusion and 4 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions (time frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to post-training [approximately 2-weeks after baseline]). The study lists 3 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 NCT04558060, 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 22 Sep 2020.