Mental HealthCOACHNCT01893983
Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
A study testing Motivational Coaching in people with Mental Health and Rural Health, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to investigate health problems among rural Veterans. The research project also aims to test a new telephone-based approach for helping Veterans who need treatment connect with the appropriate care. This study will help us to better understand the kinds of problems Veterans experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Rural Health, Veterans Health
- What is being tested?
- Motivational Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2015to 30 Sep 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
- a Veteran over age 18
- a resident of VISN 16 or 21 catchment areas receiving care at a CBOC with no plans to re-locate within 8 months of enrollment
- positive for 1 or more of the following disorders: PTSD, depression, generalized anxiety disorder, panic disorder, high-risk drinking, and/or illicit substance use
Who cannot join
- hearing- impaired,
- no working telephone,
- Veterans with self-reported (and/or CPRS-confirmed) diagnoses of schizophrenia, psychosis or bipolar disorder, or active suicidality or homicidality
- received mental health treatment within the last 60 days and/or has future appointments for mental health treatment in the next 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
About this study
The purpose of this study is to investigate health problems among rural Veterans. The research project also aims to test a new telephone-based approach for helping Veterans who need treatment connect with the appropriate care. This study will help us to better understand the kinds of problems Veterans experience. The study will also help us to find better ways to help Veterans get the help they may need.
Read the detailed description
Project Background: One in five Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) Veterans resides in rural areas and primarily receives care from VA Community-Based Outpatient Clinics (CBOCs). Compared to their urban counterparts, rural Veterans experience a significantly greater MH burden and poorer outcomes. Nevertheless, less than 10% of OEF/OIF/OND Veterans with a new PTSD diagnosis attend a minimum number of sessions required for evidence-based treatment, with rurality being one of the strongest predictors of poor engagement. The investigators' pilot study in urban OEF/OIF/OND Veterans demonstrated that telephone Motivational Interviewing (MI) delivered by research staff significantly improved MH treatment initiation and retention in care. However, the investigators do not know whether telephone MI will have as strong an effect on MH treatment engagement when implemented by VA staff in CBOCs serving rural Veterans.
Project Objectives: As a part of the Center for Mental Healthcare and Outcomes Research (CeMOHR) CREATE application to improve rural Veterans' access to evidence-based mental healthcare, the overall goal of this project is to adapt, implement and test an MI-based coaching intervention to improve MH services engagement at CBOCs serving rural Veterans. The specific aims of this project are: (1) Conduct a developmental formative evaluation of perceived barriers to MH treatment engagement and adapt the MI-based treatment engagement intervention and implementation strategy to the needs of stakeholders; (2) Conduct a randomized multi-site pragmatic effectiveness trial comparing MH Referral alone with MH Referral plus MI-based coaching; and (3) Conduct an implementation-focused formative evaluation and use this information to make mid-course corrections to the implementation strategy based on stakeholder and key informant input.
Methods: The investigators will conduct the pragmatic effectiveness trial of the telephone motivational coaching intervention to determine whether, in comparison to MH Referral alone, telephone MI coaching improves MH treatment initiation and retention, the use of e-health MH resources, and perceived need and readiness for and access to MH treatment among rural Veterans who use CBOCs (Aim 2).
Impact: This research will help close the knowledge gap about barriers to care and preferences for MH services among rural Veterans. In addition, information from this project will be used to develop implementation toolkits for MH treatment engagement interventions for rural Veterans. Finally, this project will determine the effectiveness of a telephone Motivational Interviewing engagement intervention using e-health adjuncts, thereby filling a gap in the scientific literature about whether novel interventions can be used by VA staff in CBOCs to overcome rural-urban disparities in MH treatment engagement.
- Conditions
- Mental Health, Rural Health, Veterans Health
- Being tested
- Motivational Coaching
- Keywords
- Mental Health, Veterans Health, Rural, Motivational Interviewing
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational CoachingBehavioural
Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment
| Study group | Role | What they receive |
|---|---|---|
| Motivational Coaching | Experimental | Telephone based Motivational Coaching sessions Receives: Behavioral: Motivational Coaching |
| Referral alone | No intervention | This is the current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health (MH) Treatment Engagement
Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates
Measured: 26 months
Secondary outcomes (1)
Mental Health (MH) Treatment Retention
Motivational Coaching (vs. Control) on MH treatment retention. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start1 Oct 2015
- Primary completion31 May 2018
- Study completion30 Sep 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 (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen H Seal, MD MPH, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893983
- Sponsor's protocol ID
- CRE 12-083
- Acronym
- COACH
- Status last verified
- Aug 2019
- First submitted
- 21 Jun 2013
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koenig CJ, Abraham T, Zamora KA, Hill C, Kelly PA, Uddo M, Hamilton M, Pyne JM, Seal KH. Pre-Implementation Strategies to Adapt and Implement a Veteran Peer Coaching Intervention to Improve Mental Health Treatment Engagement Among Rural Veterans. J Rural Health. 2016 Sep;32(4):418-428. doi: 10.1111/jrh.12201. Epub 2016 Aug 10.
PubMed 27509291Abraham TH, Koenig CJ, Zamora K, Hill C, Uddo M, Kelly AP, Hamilton MF, Curran GM, Pyne JM, Seal KH. Situating mental health work in place: Qualitative findings from interviews with Veterans in Southeastern Louisiana and Northern California. Health Place. 2017 Sep;47:63-70. doi: 10.1016/j.healthplace.2017.07.001. Epub 2017 Jul 26.
PubMed 28755653
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
- ClinicalTrials.gov ID
- NCT01893983
- Acronym / sponsor ID
- COACH / CRE 12-083
- Conditions
- Mental Health, Rural Health, Veterans Health
- Keywords
- Mental Health, Veterans Health, Rural, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Posted 27 Sep 2019
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 investigate health problems among rural Veterans. The research project also aims to test a new telephone-based approach for helping Veterans who need treatment connect with the appropriate care. This study will help us to better understand the kinds of problems Veterans experience. The study will also help us to find better ways to help Veterans get the help they may need.
Detailed description
Project Background: One in five Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND) Veterans resides in rural areas and primarily receives care from VA Community-Based Outpatient Clinics (CBOCs). Compared to their urban counterparts, rural Veterans experience a significantly greater MH burden and poorer outcomes. Nevertheless, less than 10% of OEF/OIF/OND Veterans with a new PTSD diagnosis attend a minimum number of sessions required for evidence-based treatment, with rurality being one of the strongest predictors of poor engagement. The investigators' pilot study in urban OEF/OIF/OND Veterans demonstrated that telephone Motivational Interviewing (MI) delivered by research staff significantly improved MH treatment initiation and retention in care. However, the investigators do not know whether telephone MI will have as strong an effect on MH treatment engagement when implemented by VA staff in CBOCs serving rural Veterans.
Project Objectives: As a part of the Center for Mental Healthcare and Outcomes Research (CeMOHR) CREATE application to improve rural Veterans' access to evidence-based mental healthcare, the overall goal of this project is to adapt, implement and test an MI-based coaching intervention to improve MH services engagement at CBOCs serving rural Veterans. The specific aims of this project are: (1) Conduct a developmental formative evaluation of perceived barriers to MH treatment engagement and adapt the MI-based treatment engagement intervention and implementation strategy to the needs of stakeholders; (2) Conduct a randomized multi-site pragmatic effectiveness trial comparing MH Referral alone with MH Referral plus MI-based coaching; and (3) Conduct an implementation-focused formative evaluation and use this information to make mid-course corrections to the implementation strategy based on stakeholder and key informant input.
Methods: The investigators will conduct the pragmatic effectiveness trial of the telephone motivational coaching intervention to determine whether, in comparison to MH Referral alone, telephone MI coaching improves MH treatment initiation and retention, the use of e-health MH resources, and perceived need and readiness for and access to MH treatment among rural Veterans who use CBOCs (Aim 2).
Impact: This research will help close the knowledge gap about barriers to care and preferences for MH services among rural Veterans. In addition, information from this project will be used to develop implementation toolkits for MH treatment engagement interventions for rural Veterans. Finally, this project will determine the effectiveness of a telephone Motivational Interviewing engagement intervention using e-health adjuncts, thereby filling a gap in the scientific literature about whether novel interventions can be used by VA staff in CBOCs to overcome rural-urban disparities in MH treatment engagement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Coaching | Experimental | Behavioral: Motivational CoachingTelephone based Motivational Coaching sessions |
| Referral alone | No intervention | –This is the current standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a Veteran over age 18
- a resident of VISN 16 or 21 catchment areas receiving care at a CBOC with no plans to re-locate within 8 months of enrollment
- positive for 1 or more of the following disorders: PTSD, depression, generalized anxiety disorder, panic disorder, high-risk drinking, and/or illicit substance use
Key exclusion criteria (4 listed)
- hearing- impaired,
- no working telephone,
- Veterans with self-reported (and/or CPRS-confirmed) diagnoses of schizophrenia, psychosis or bipolar disorder, or active suicidality or homicidality
- received mental health treatment within the last 60 days and/or has future appointments for mental health treatment in the next 30 days
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 |
|---|---|---|
| Motivational CoachingTelephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment | Behavioural | Motivational Coaching |
Primary outcome
Mental Health (MH) Treatment Engagement
Time frame: 26 months
Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates
1 secondary outcome
Mental Health (MH) Treatment Retention
Time frame: 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27509291Koenig CJ, Abraham T, Zamora KA, Hill C, Kelly PA, Uddo M, Hamilton M, Pyne JM, Seal KH. Pre-Implementation Strategies to Adapt and Implement a Veteran Peer Coaching Intervention to Improve Mental Health Treatment Engagement Among Rural Veterans. J Rural Health. 2016 Sep;32(4):418-428. doi: 10.1111/jrh.12201. Epub 2016 Aug 10.
- Results publication: PubMed 28755653Abraham TH, Koenig CJ, Zamora K, Hill C, Uddo M, Kelly AP, Hamilton MF, Curran GM, Pyne JM, Seal KH. Situating mental health work in place: Qualitative findings from interviews with Veterans in Southeastern Louisiana and Northern California. Health Place. 2017 Sep;47:63-70. doi: 10.1016/j.healthplace.2017.07.001. Epub 2017 Jul 26.
- Click here for more information about this study: Motivational Coaching to Enhance Mental Health Engagement in Rural VeteransLink provided by the sponsor.
- 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.
Karen H Seal, MD MPH principal investigator
San Francisco VA Medical Center, San Francisco, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Coaching in people with Mental Health and Rural Health, run by VA Office of Research and Development at 2 sites 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 3 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 27 Sep 2019). 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?
Mental Health (MH) Treatment Engagement (time frame: 26 months). 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 NCT01893983, which also lists 2 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 27 Sep 2019.