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Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans (COACH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01893983
First received: June 21, 2013
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Mental Health
Rural Health
Veterans Health
Behavioral: Motivational Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Mental Health (MH) Treatment Engagement [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mental Health (MH) Treatment Retention [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: October 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Coaching
Telephone based Motivational Coaching sessions
Behavioral: Motivational Coaching
Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment
No Intervention: Referral alone
This is the current standard of care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893983

Contacts
Contact: Coleen E Hill, BA (415) 221-4810 ext 3944 coleen.hill@va.gov
Contact: Nicole McCamish, MA (415) 221-4810 ext 4284 Nicole.McCamish@va.gov

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR Recruiting
No. Little Rock, Arkansas, United States, 72114-1706
Contact: Regina Stanley, BS    501-257-1730    Regina.Stanley2@va.gov   
Sub-Investigator: Jeffrey M Pyne, MD         
Sub-Investigator: Traci H Abraham, PhD         
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Coleen E Hill, BA    415-221-4810 ext 3944    coleen.hill@va.gov   
Contact: Nicole McCamish, MA    (415) 221-4810 ext 4284    Nicole.McCamish@va.gov   
Principal Investigator: Karen H Seal, MD MPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Karen H Seal, MD MPH San Francisco VA Medical Center, San Francisco, CA
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01893983     History of Changes
Other Study ID Numbers: CRE 12-083 
Study First Received: June 21, 2013
Last Updated: August 12, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Mental Health
Veterans Health
Rural
Motivational Interviewing

ClinicalTrials.gov processed this record on September 23, 2016