Healthcare DisparitiesPARTNER-MHNCT04515771

Improving Patient-Provider Communication to Reduce Mental Health Disparities

A study testing PARTNER-MH in people with Healthcare Disparities and Mental Health, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Healthcare Disparities, Mental Health
What is being tested?: PARTNER-MH
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2020to 15 Apr 2022
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
No healthy volunteers
Adult, Older adult

Who may be able to join

To be eligible:
Must be a Veteran belonging to a racial/ethnic minoritized group
Must be actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
Must have started receiving mental health care as a new patient in the Outpatient Mental Health within 12 months prior to enrollment into the study

Who cannot join

Not eligible if:
Is a Veteran not belonging to a racial/ethnic minoritized group
Not actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
Started receiving mental health care as a new patient in the Outpatient Mental Health outside of the 12-month window

Trial locations and contacts

1 site in 1 country.

United States1 site

Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Improving Patient-provider Communication to Reduce Mental Health Disparities (CDA 16-153)

The purpose of this study was to develop and pilot test an intervention to reduce mental health disparities for racially and ethnically minoritized Veterans receiving outpatient VA mental health services. The program was delivered by trained VA peer navigators. The specific aims of the program were to enhance navigation of mental health services, increase patient engagement, and improve patient-provider communication.

Study participants were randomized into one of two study groups, which determined when they received the study intervention. Regardless of study group, participants had the opportunity to receive services in addition to their regular mental health treatment (either immediately after enrollment into the study or after a 6-month waiting period).

Participants were asked to complete study questionnaires at different timepoints throughout the study to assess their overall satisfaction with the study program and the mental health services that they received. Some participants also completed an interview to discuss their experience in the program.

Conditions: Healthcare Disparities, Mental Health
Being tested: PARTNER-MH
Keywords: Social Determinants of Health, Minority Health, Veterans Health, Patient Participation, Patient Navigation, Mental Health Services
Medical subject headings: Psychological Well-Being, Patient Participation

What participants receive

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

PARTNER-MHBehavioural
The study intervention consisted of a 6-month, manualized, peer-led navigation program. It involved assessing and addressing patients' unmet social needs and barriers to care, delivery of peer support services, navigation to VA mental health services, and psychoeducation.

Study groups in NCT04515771
Study group	Role	What they receive
Active PARTNER-MH	Experimental	Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention. Receives: Behavioral: PARTNER-MH
Waitlist Control	Other	The waitlist control arm participants received usual mental health services. They were offered to receive the intervention after the 6-month wait period. Receives: Behavioral: PARTNER-MH

What is being measured

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

Patient Activation Measure- Mental Health (PAM-MH)
Measure Description: The PAM-MH is a 13-item questionnaire that measures an individual's perceived ability to manage illness and health behaviors. The questions are rated on a 4-point Likert-type scale (1= strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores are then converted using Rasch analysis to a 100-point scale. Raw scores range from 13 to 52 and converted activation scores range from 0-100. Higher activation scores indicate higher level of patient activation.
Measured: Change from Baseline to 6 months
Altarum Consumer Engagement (ACE) Change
The ACE is administered as a 5-level Likert scale. The subscale scores range from 5 to 25, and the total engagement score is computed by adding the 3 subscale scores and multiplying the sum by 4/3 to obtain a possible range score of 20 to 100. Higher scores represent higher patient engagement.
Measured: Change from Baseline to 6 months
SDM-Q9 PARTNER-MH
The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s SDM-Q-9 informed decision-making scale. The original, validated scale, the SDM-Q-9, has 9 items measured on a 6-point Likert Scale, ranging from 0=completely disagree to 5=completely agree. The total score is calculated by summing the scores of the nine items, range from 0 to 45. A higher score indicates a greater level of perceived SDM.
Measured: Change from Baseline to 6 months
Peer Coaching Experience Satisfaction Questionnaire
Peer Coaching Experience Satisfaction Questionnaire is designed to collect feedback on a respondent's overall experience with a peer coach at the end of a 6-month period. Only participants in active PARTNER-MH were administered this questionnaire. This questionnaire was developed for the study. Question 1: Overall, how satisfied are you with PARTNER-MH program? Question 2: How satisfied are you with your assigned peer. Answers are rated on a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied).
Measured: Administered after completion of the study program (6 months for Active PARTNER-MH )
Trust and Satisfaction Survey Responses Change
The Trust and Satisfaction Survey is a 5-item scale which assess a respondent's degree of trust toward the VA, VA mental health care services, and the study program. Respondents are asked to rate how much they agree with each of the 5 items. Items are rated on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The survey yields final scores ranging from 5 (minimum) to 25 (maximum) with higher scores representing greater trust and satisfaction. No subscale.
Measured: Change from Baseline to 6 months

Secondary outcomes (5)

Veteran's RAND 12-item Health Survey (VR-12) Change
The Veterans Rand 12-item Health Survey (VR-12) is a 12-item scale that assesses Veterans' report of health-related quality of life. It measures mental and physical functioning. The VR-12 uses five-point ordinal response choices and provides two scores: the Physical Component Summary Score and the Mental Health Summary Score, ranging from 0 to 100. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. The scores are compared to the population average, measured in standard deviations. The United States population average PCS and MCS are 50 points each. The United States population standard deviation is 10 points. Higher scores indicate better self-reported health. Lower VR-12 MCS scores indicate worse psychological distress/functioning. Clinically significant scores vary based on the condition or disease population.
Measured: Change from Baseline to 6 months
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
The Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) is 5-item scale rated on a 10-point Likert scale ranging from 1 (not confident at all) to 10 (very confident) and the total score, which is the sum of all item ratings, range from 0 (minimum) to 50 (maximum). Higher scores indicate higher levels of self-efficacy. There is no subscale.
Measured: Change from Baseline to 6 months
Working Alliance Inventory Short-Revised (WAI-SR) Change
Working Alliance Inventory -Short Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their mental health providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= seldom to 5= always. The WAI-SR has 3 subscales: The Goal, Task, and Bond subscales each have 4 items and scores ranging from 4 to 20. For research purposes, use of the overall mean scores of the WAI-SR rather than its subscales have been recommended. The scale total scores range from 12 (minimum) to 60 (maximum). Higher scores indicate higher level of working alliance. There is no cut off score for this scale.
Measured: Change from Baseline to 6 months
UCLA Loneliness Scale (ULS-6) Change
The UCLA Loneliness Scale Short Form, (ULS-6), is a 6-item scale that assesses loneliness and is rated on a 4-point Likert Scale, ranging from 1=never to 4= often. The scale has a total summed score ranging from 6 (minimum) to 24 (maximum), with higher scores indicate higher level of loneliness.
Measured: Change from Baseline to 6 months
Patient Health Questionnaire (PHQ-9) Change
Measure Description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It includes 9 items, ranging in scores from 0 to 27. Higher scores indicate more severe symptoms of depression.
Measured: Change from Baseline to 6 months

Timeline

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

17 Aug 202015 Apr 2022

First posted17 Aug 2020
Study start17 Aug 2020
Primary completion15 Apr 2022
Study completion15 Apr 2022

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 (3)Papers the sponsor has linked to this study.
Other trials for Healthcare DisparitiesStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Crossover
Model description: The study consisted of two groups, an active treatment group and a waitlist control group. Participants randomized to the active treatment group received the peer-administered intervention program for 6 months and then were followed for 3 months after completion of the program. The waitlist control group received the peer-administered intervention program for 6 months following a 6-month waiting period.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04515771
Sponsor's protocol ID: CDX 20-003
Acronym: PARTNER-MH
Status last verified: Aug 2024
First submitted: 12 Aug 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Final research datasets underlying all publications reporting results of VA research can be made available, upon FOIA request. Upon request, a limited dataset will be made available for other researchers for the purposes of validation of findings. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent findings and view supplemental details that might not be included in publications.

Publications

Eliacin J, Matthias MS, Cameron KA, Burgess DJ. Veterans' views of PARTNER-MH, a peer-led patient navigation intervention, to improve patient engagement in care and patient-clinician communication: A qualitative study. Patient Educ Couns. 2023 Sep;114:107847. doi: 10.1016/j.pec.2023.107847. Epub 2023 Jun 13.
PubMed 37331280
Eliacin J, Burgess D, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Chinman M, Slaven JE, Matthias MS. Outcomes of a peer-led navigation program, PARTNER-MH, for racially minoritized Veterans receiving mental health services: a pilot randomized controlled trial to assess feasibility and acceptability. Transl Behav Med. 2023 Sep 12;13(9):710-721. doi: 10.1093/tbm/ibad027.
PubMed 37130337
Eliacin J, Burgess DJ, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Slaven JE, O'Connor C, Walker K, Zou DS, Austin E, Akins J, Miller J, Chinman M, Matthias MS. Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 Sep 6;11(9):e37712. doi: 10.2196/37712.
PubMed 36066967

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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Patient-provider Communication to Reduce Mental Health Disparities (CDA 16-153)
ClinicalTrials.gov ID: NCT04515771
Acronym / sponsor ID: PARTNER-MH / CDX 20-003
Conditions: Healthcare Disparities, Mental Health
Keywords: Social Determinants of Health, Minority Health, Veterans Health, Patient Participation, Patient Navigation, Mental Health Services
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 17 Aug 2020 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 17 Aug 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The study consisted of two groups, an active treatment group and a waitlist control group. Participants randomized to the active treatment group received the peer-administered intervention program for 6 months and then were followed for 3 months after completion of the program. The waitlist control group received the peer-administered intervention program for 6 months following a 6-month waiting period.

Arm	Type	Receives
Active PARTNER-MH	Experimental	Behavioral: PARTNER-MHParticipants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
Waitlist Control	Other	Behavioral: PARTNER-MHThe waitlist control arm participants received usual mental health services. They were offered to receive the intervention after the 6-month wait period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must be a Veteran belonging to a racial/ethnic minoritized group
Must be actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
Must have started receiving mental health care as a new patient in the Outpatient Mental Health within 12 months prior to enrollment into the study

Key exclusion criteria (4 listed)

Is a Veteran not belonging to a racial/ethnic minoritized group
Not actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
Started receiving mental health care as a new patient in the Outpatient Mental Health outside of the 12-month window

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
PARTNER-MHThe study intervention consisted of a 6-month, manualized, peer-led navigation program. It involved assessing and addressing patients' unmet social needs and barriers to care, delivery of peer support services, navigation to VA mental health services, and psychoeducation.	Behavioural	Active PARTNER-MH, Waitlist Control

Primary outcome

Patient Activation Measure- Mental Health (PAM-MH)
Time frame: Change from Baseline to 6 months
Measure Description: The PAM-MH is a 13-item questionnaire that measures an individual's perceived ability to manage illness and health behaviors. The questions are rated on a 4-point Likert-type scale (1= strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores are then converted using Rasch analysis to a 100-point scale. Raw scores range from 13 to 52 and converted activation scores range from 0-100. Higher activation scores indicate higher level of patient activation.
Altarum Consumer Engagement (ACE) Change
Time frame: Change from Baseline to 6 months
The ACE is administered as a 5-level Likert scale. The subscale scores range from 5 to 25, and the total engagement score is computed by adding the 3 subscale scores and multiplying the sum by 4/3 to obtain a possible range score of 20 to 100. Higher scores represent higher patient engagement.
SDM-Q9 PARTNER-MH
Time frame: Change from Baseline to 6 months
The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s SDM-Q-9 informed decision-making scale. The original, validated scale, the SDM-Q-9, has 9 items measured on a 6-point Likert Scale, ranging from 0=completely disagree to 5=completely agree. The total score is calculated by summing the scores of the nine items, range from 0 to 45. A higher score indicates a greater level of perceived SDM.
Peer Coaching Experience Satisfaction Questionnaire
Time frame: Administered after completion of the study program (6 months for Active PARTNER-MH )
Peer Coaching Experience Satisfaction Questionnaire is designed to collect feedback on a respondent's overall experience with a peer coach at the end of a 6-month period. Only participants in active PARTNER-MH were administered this questionnaire. This questionnaire was developed for the study. Question 1: Overall, how satisfied are you with PARTNER-MH program? Question 2: How satisfied are you with your assigned peer. Answers are rated on a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied).
Trust and Satisfaction Survey Responses Change
Time frame: Change from Baseline to 6 months
The Trust and Satisfaction Survey is a 5-item scale which assess a respondent's degree of trust toward the VA, VA mental health care services, and the study program. Respondents are asked to rate how much they agree with each of the 5 items. Items are rated on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The survey yields final scores ranging from 5 (minimum) to 25 (maximum) with higher scores representing greater trust and satisfaction. No subscale.

5 secondary outcomes

Veteran's RAND 12-item Health Survey (VR-12) Change
Time frame: Change from Baseline to 6 months
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
Time frame: Change from Baseline to 6 months
Working Alliance Inventory Short-Revised (WAI-SR) Change
Time frame: Change from Baseline to 6 months
UCLA Loneliness Scale (ULS-6) Change
Time frame: Change from Baseline to 6 months
Patient Health Questionnaire (PHQ-9) Change
Time frame: Change from Baseline to 6 months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active PARTNER-MH	30	18
Waitlist Control	20	18

Primary outcome: Patient Activation Measure- Mental Health (PAM-MH)

Time frame: Change from Baseline to 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Active PARTNER-MH n = 18	Waitlist Control n = 18
Value	5.7 (16.5)	9.1 (11.7)

Primary outcome: Altarum Consumer Engagement (ACE) Change

Time frame: Change from Baseline to 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Active PARTNER-MH n = 18	Waitlist Control n = 18
Value	5.5 (11.5)	2.9 (10.4)

Primary outcome: SDM-Q9 PARTNER-MH

Time frame: Change from Baseline to 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Active PARTNER-MH n = 18	Waitlist Control n = 18
Value	1.9 (13.5)	1.3 (7.1)

Primary outcome: Peer Coaching Experience Satisfaction Questionnaire

Time frame: Administered after completion of the study program (6 months for Active PARTNER-MH ). Number. Unit: participants

Measure	Active PARTNER-MH n = 14
Question 1 Very satisified	6
Question 1 Satisified	4
Question 1 Neutral	2
Question 1 Dissatisfied	1
Question 1 Very dissatisfied	1
Question 2 Very satisfied	11
Question 2 Satisfied	1
Question 2 Neutral	1

Population analysed: Only 14 participants answered the question.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored and assessed from the time of study entry at baseline until the end of study participation at 6 months (primary endpoint), or 12 months for those who were in the waitlist control arm and opted to receive the intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active PARTNER-MH	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Waitlist Control	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): The study had some limitations that should be considered. The study was conducted with a small sample at one VHA site. It was not powered to detect significant changes. Therefore, findings should be interpreted with caution. The retention rate in the study was also moderate and differed by study group. Future evaluation of PARTNER-MH should also examine outcomes over a longer period to assess patients' health services utilization and engagement in mental health treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37331280Eliacin J, Matthias MS, Cameron KA, Burgess DJ. Veterans' views of PARTNER-MH, a peer-led patient navigation intervention, to improve patient engagement in care and patient-clinician communication: A qualitative study. Patient Educ Couns. 2023 Sep;114:107847. doi: 10.1016/j.pec.2023.107847. Epub 2023 Jun 13.
Derived from this study: PubMed 37130337Eliacin J, Burgess D, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Chinman M, Slaven JE, Matthias MS. Outcomes of a peer-led navigation program, PARTNER-MH, for racially minoritized Veterans receiving mental health services: a pilot randomized controlled trial to assess feasibility and acceptability. Transl Behav Med. 2023 Sep 12;13(9):710-721. doi: 10.1093/tbm/ibad027.
Derived from this study: PubMed 36066967Eliacin J, Burgess DJ, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Slaven JE, O'Connor C, Walker K, Zou DS, Austin E, Akins J, Miller J, Chinman M, Matthias MS. Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 Sep 6;11(9):e37712. doi: 10.2196/37712.
Individual participant dataSharing planned: Yes. Final research datasets underlying all publications reporting results of VA research can be made available, upon FOIA request. Upon request, a limited dataset will be made available for other researchers for the purposes of validation of findings. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent findings and view supplemental details that might not be included in publications.

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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.

Johanne Eliacin, PhD principal investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

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

Questions about this trial

What is this clinical trial studying?

A study testing PARTNER-MH in people with Healthcare Disparities and Mental Health, run by VA Office of Research and Development 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 4 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 19 Sep 2024. 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 19 Sep 2024). 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?

Patient Activation Measure- Mental Health (PAM-MH) (time frame: Change from Baseline to 6 months). The study lists 5 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 NCT04515771, which also lists 3 linked publications.

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 19 Sep 2024.