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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01893983
First received: June 21, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to investigate combat-related 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 recently returned 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 Department of Veterans Affairs:

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. We 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. We will adjust by clustering for CBOC and region as well as potential confounding by other covariates


Estimated Enrollment: 1000
Study Start Date: April 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: April 2017 (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 OEF/OIF/OND veterans resides in rural areas and primarily receives care from VA 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. Our 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, we 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 CeMOHR CREATE application to improve rural veterans' access to evidence-based mental healthcare (Fortney, PI), 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: We 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 to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a veteran over age 18, under the age 75.
  • 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, and from baseline assessment:
  • positive for 1 of the following disorders PTSD, depression, generalized anxiety disorder, panic disorder, high-risk drinking, and/or illicit substance use and
  • moderately ambivalent (6 on the Readiness Ruler) about initiating or re-engaging in MH treatment.

Exclusion Criteria:

  • hearing- impaired,
  • no working telephone,
  • veterans with self-reported (and/or CPRS-confirmed) diagnoses of psychosis or bipolar disorder, or active suicidality or homicidality, and from baseline assessment:
  • currently or recently engaged (<60 days of recruitment) in VA or non-VA MH treatment (will also confirm in CPRS if VA MH treatment).
  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: Nicole McCamish, MA (415) 221-4810 ext 4284 Nicole.McCamish@va.gov
Contact: Linda Abadjian, PhD (415) 221-4810 ext 3975 linda.abadjian1@va.gov

Locations
United States, Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR Not yet recruiting
Little Rock, Arkansas, United States, 72205-5484
Contact: Regina L Stanley, BA    501-257-1730    Regina.Stanley2@va.gov   
United States, California
San Francisco Not yet recruiting
San Francisco, California, United States, 94121
Contact: Nicole McCamish, MA    415-221-4810 ext 4284    Nicole.McCamish@va.gov   
Contact: Linda Abadjian, PhD    (415) 221-4810 ext 3975    linda.abadjian1@va.gov   
Principal Investigator: Karen H Seal, MD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: Karen H Seal, MD MPH San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01893983     History of Changes
Other Study ID Numbers: CRE 12-083, CRE 12-083
Study First Received: June 21, 2013
Last Updated: September 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Mental Health
Veterans Health
Rural
Motivational Interviewing

ClinicalTrials.gov processed this record on September 18, 2014