Mental Health DisordersBHIP-CCMNCT02543840

Hybrid Collaborative Care Randomized Program Evaluation

A study testing Replicating Effective Programs plus External Facilitation and Educational Materials in people with Mental Health Disorders, run by VA Boston Healthcare System 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: Mental Health Disorders
What is being tested?: Replicating Effective Programs plus External Facilitation and Educational Materials
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,112 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2016to 26 Apr 2018
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

At least three visits to the General Mental Health Clinic's BHIP team in prior year

Who cannot join

Chart evidence of dementia

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Boston Healthcare System
Boston, Massachusetts, 02131

Other trials in United States

About this study

Official title: Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health

This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).

In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Read the detailed description

Based on an internal system-wide review of mental health services and the Mental Health Action Plan submitted to Congress in November, 2011, the Office of Mental Health Operations (OMHO) has undertaken an effort to establish behavioral health interdisciplinary plans (BHIPs), which are intended to provide General Mental Health (GMH) care throughout the Department of Veterans Affairs (VA). The BHIP goal is to build effective interdisciplinary teams, which will provide the majority of care for Veterans in GMH. It is now expected that every Veterans Affairs Medical Center (VAMC) establish at least one BHIP in the current initial phase (begun in late fiscal year 2013), and that the effort scale-up subsequently. Not surprisingly, progress has been uneven.

In 2015 OMHO incorporated the Collaborative Chronic Care Model (CCM) as an evidence-based model by which to structure BHIPs. Consistent with BHIP goals, CCMs were developed to provide anticipatory, continuous, collaborative, evidence-based care. CCMs consist of 6 elements: delivery system redesign, use of clinical information systems, provider decision support, patient self-management support, linkage to community resources, and healthcare organization support. Replicating Effective Programs with External Facilitation (REP-F) has been shown to be effective in implementing complex care models, including CCMs for mental health, both within and beyond VA.

Thus in conjunction with OMHO, the investigators propose this project with the Specific Aim of evaluating the impact of REP-F in implementing CCM-based BHIPs and their effect on Veteran health status. The investigators propose a Hybrid Type III implementation-effectiveness stepped wedge controlled trial, specifically hypothesizing that:

H1: REP-F-based implementation to establish CCM-based BHIPs, compared to existing centralized technical assistance will result in: (H1a) increased Veteran perceptions of CCM-based care, (H1b) higher rates of achieving national BHIP clinical fidelity measures (implementation outcomes), and (H1c) higher provider ratings of the presence of CCM elements.

H2: CCM-based BHIPs, supported by REP-F implementation, will result in improved Veteran health outcomes compared to BHIPs supported by dissemination material alone (intervention outcomes).

The investigators will utilize the national BHIP rollout as a vehicle for this project. Using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Conditions: Mental Health Disorders
Being tested: Replicating Effective Programs plus External Facilitation, Educational Materials
Keywords: Quality Improvement, Organization of Services, Implementation

What participants receive

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

Replicating Effective Programs plus External FacilitationOther
Also called REP-F
Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
Educational MaterialsOther
Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F

Study groups in NCT02543840
Study group	Role	What they receive
Implementation Facilitation	Experimental	Implementation Facilitation consists of the Center for Disease Control's Replicating Effective Programs, plus External Facilitation. The intervention lasts 6 months followed by a 6-month step-down period. Receives: Other: Replicating Effective Programs plus External Facilitation
Educational Materials	Placebo comparator	Dissemination of available materials explaining the Collaborative Chronic Care Model and implementation tools. Sites randomized to delay initiation of facilitation will have these materials plus technical assistance for 4 or 8 months prior to full implementation facilitation. Receives: Other: Educational Materials

What is being measured

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

Veterans RAND-12 Mental Component Score (VR-12 MCS)
Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score.
Measured: one year

Secondary outcomes (9)

Veterans RAND-12 Physical Component Scores (VR-12 PCS)
Veterans RAND-Physical Component Score: Overall self-rated physical health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Mental Component Score.
Measured: One year
Satisfaction Index
Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72.
Measured: One year
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100.
Measured: One year
Patient Assessment of Chronic Illness Care (PACIC)
Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33.
Measured: One year
Team Development Measure (TDM)- Cohesion
Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure.
Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Measured: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Communication
Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure.
Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Measured: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Role Clarity
Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure.
Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Measured: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Team Primacy
Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure.
Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Measured: baseline and during stepdown (6-12 months)
Mental Health Hospitalization Rates
Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months.
Measured: Two years

Timeline

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

7 Mar 201626 Apr 2018

First posted7 Sep 2015 (estimated)
Study start7 Mar 2016
Primary completion26 Apr 2018
Study completion26 Apr 2018

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 (8)Papers the sponsor has linked to this study.
Other trials for Mental Health DisordersStudies 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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 1,112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02543840
Sponsor's protocol ID: 15-289
Other IDs: QUE-15-289
Acronym: BHIP-CCM
Status last verified: Jun 2020
First submitted: 4 Sep 2015
Last updated: 23 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012 Aug;169(8):790-804. doi: 10.1176/appi.ajp.2012.11111616.
PubMed 22772364
Miller CJ, Grogan-Kaylor A, Perron BE, Kilbourne AM, Woltmann E, Bauer MS. Collaborative chronic care models for mental health conditions: cumulative meta-analysis and metaregression to guide future research and implementation. Med Care. 2013 Oct;51(10):922-30. doi: 10.1097/MLR.0b013e3182a3e4c4.
PubMed 23938600
Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.
PubMed 24129806
Sullivan JL, Kim B, Miller CJ, Elwy AR, Drummond KL, Connolly SL, Riendeau RP, Bauer MS. Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation. Implement Sci Commun. 2021 Mar 24;2(1):33. doi: 10.1186/s43058-021-00133-w.
PubMed 33762023
Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.
PubMed 32131824
Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019 May 3;14(1):46. doi: 10.1186/s13012-019-0893-3.
PubMed 31053157
Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.
PubMed 30821830
Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7.
PubMed 26912342

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 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
ClinicalTrials.gov ID: NCT02543840
Acronym / sponsor ID: BHIP-CCM / 15-289
Conditions: Mental Health Disorders
Keywords: Quality Improvement, Organization of Services, Implementation
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,112 participants (actual)
Lead sponsor: VA Boston Healthcare SystemUS federal agency
Collaborators: US Department of Veterans Affairs
Study start: 7 Mar 2016 (actual)
Primary completion: 26 Apr 2018 (actual)
Study completion: 26 Apr 2018 (actual)
First posted: 7 Sep 2015 (estimated)
Results: Posted 23 Jun 2020

Clinical summary

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

Detailed description

H2: CCM-based BHIPs, supported by REP-F implementation, will result in improved Veteran health outcomes compared to BHIPs supported by dissemination material alone (intervention outcomes).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Implementation Facilitation	Experimental	Other: Replicating Effective Programs plus External FacilitationImplementation Facilitation consists of the Center for Disease Control's Replicating Effective Programs, plus External Facilitation. The intervention lasts 6 months followed by a 6-month step-down period.
Educational Materials	Placebo comparator	Other: Educational MaterialsDissemination of available materials explaining the Collaborative Chronic Care Model and implementation tools. Sites randomized to delay initiation of facilitation will have these materials plus technical assistance for 4 or 8 months prior to full implementation facilitation.

Who may qualify

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

Key inclusion criteria (1 listed)

At least three visits to the General Mental Health Clinic's BHIP team in prior year

Key exclusion criteria (1 listed)

Chart evidence of dementia

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
Replicating Effective Programs plus External FacilitationAlso: REP-FPackaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation	Other	Implementation Facilitation
Educational MaterialsDissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F	Other	Educational Materials

Primary outcome

Veterans RAND-12 Mental Component Score (VR-12 MCS)
Time frame: one year
Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score.

9 secondary outcomes

Veterans RAND-12 Physical Component Scores (VR-12 PCS)
Time frame: One year
Satisfaction Index
Time frame: One year
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Time frame: One year
Patient Assessment of Chronic Illness Care (PACIC)
Time frame: One year
Team Development Measure (TDM)- Cohesion
Time frame: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Communication
Time frame: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Role Clarity
Time frame: baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Team Primacy
Time frame: baseline and during stepdown (6-12 months)
Mental Health Hospitalization Rates
Time frame: Two years

Results and safety

Results posted to the registry on 23 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Veteran Participants	1,050	1,050
Provider Participants	62	62

Primary outcome: Veterans RAND-12 Mental Component Score (VR-12 MCS)

Time frame: one year. Mean (Standard Deviation). Unit: score on a scale

Measure	Veteran Participants n = 1050
Baseline (T0)	36.82 (14.78)
Six Month Timepoint (T6)	36.24 (14.26)
Final Twelve Month Timepoint (T12)	37.25 (14.07)

Veteran Participants: Mean Difference (Final Values): 0.2 (95% CI -1.26 to 1.5), p <0.01, Mixed Models Analysis
Veteran Participants: Mean Difference (Final Values): 5.03 (95% CI 2.24 to 7.82), p <0.001, Regression, Linear

Population analysed: Adjusted mixed model of single group with repeated event. Number Analyzed = number of participants with available data at the specified time points. 1050 participants completed 1436 interviews across one or more time points: t0, t6, t12. 589 started at t0 (missing=4); 65 added at t6 (missing=1); 386 added at t12 (missing=5).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Full duration of the study from March 2016 through April 2018, approximately 1 year and 1 month.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Veteran Participants	0 of 1,050 (0%)	0 of 1,050 (0%)	0 of 1,050
Provider Participants	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Limitations and caveats (from the sponsor): All facilities received implementation support, randomized as to start time. There was thus no independent parallel control group. However, several validity checks were conducted to establish internal validity of positive findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22772364Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012 Aug;169(8):790-804. doi: 10.1176/appi.ajp.2012.11111616.
Background: PubMed 23938600Miller CJ, Grogan-Kaylor A, Perron BE, Kilbourne AM, Woltmann E, Bauer MS. Collaborative chronic care models for mental health conditions: cumulative meta-analysis and metaregression to guide future research and implementation. Med Care. 2013 Oct;51(10):922-30. doi: 10.1097/MLR.0b013e3182a3e4c4.
Background: PubMed 24129806Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.
Derived from this study: PubMed 33762023Sullivan JL, Kim B, Miller CJ, Elwy AR, Drummond KL, Connolly SL, Riendeau RP, Bauer MS. Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation. Implement Sci Commun. 2021 Mar 24;2(1):33. doi: 10.1186/s43058-021-00133-w.
Derived from this study: PubMed 32131824Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.
Derived from this study: PubMed 31053157Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019 May 3;14(1):46. doi: 10.1186/s13012-019-0893-3.
Derived from this study: PubMed 30821830Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.
Derived from this study: PubMed 26912342Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7.
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.

Mark S Bauer, MD principal investigator

VA Boston Healthcare System

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

Questions about this trial

What is this clinical trial studying?

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 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: finished, as of the sponsor's last update on 23 Jun 2020. 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. Some participants in this study may receive a placebo. 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 23 Jun 2020). 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?

Veterans RAND-12 Mental Component Score (VR-12 MCS) (time frame: one year). 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 NCT02543840, which also lists 8 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 23 Jun 2020.