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Trial record 25 of 5485 for:    veterans

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

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ClinicalTrials.gov Identifier: NCT01893983
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE July 9, 2013
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
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. We will adjust by clustering for CBOC and region as well as potential confounding by other covariates
Change History Complete list of historical versions of study NCT01893983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
Mental Health (MH) Treatment Retention [ Time Frame: 26 months ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Mental Health (MH) Treatment Retention [ Time Frame: 26 months ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
Official Title  ICMJE Motivational Coaching to Enhance Mental Health Engagement in Rural Veterans
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Mental Health
  • Rural Health
  • Veterans Health
Intervention  ICMJE Behavioral: Motivational Coaching
Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment
Study Arms  ICMJE
  • Experimental: Motivational Coaching
    Telephone based Motivational Coaching sessions
    Intervention: Behavioral: Motivational Coaching
  • No Intervention: Referral alone
    This is the current standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
697
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
280
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893983
Other Study ID Numbers  ICMJE CRE 12-083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen H Seal, MD MPH San Francisco VA Medical Center, San Francisco, CA
PRS Account VA Office of Research and Development
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP