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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01893983
Other study ID # CRE 12-083
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date September 30, 2018

Study information

Verified date August 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study will also help us to find better ways to help Veterans get the help they may need.


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.


Recruitment information / eligibility

Status Completed
Enrollment 418
Est. completion date September 30, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Coaching
Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment

Locations

Country Name City State
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR North Little Rock Arkansas
United States San Francisco VA Medical Center, San Francisco, CA San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Abraham 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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures. Depression, anxiety, panic, PTSD, tobacco, alcohol, cannabis, cocaine, amphetamine, inhalants, sedatives, hallucinogen, opioid, and QOL domains: physical health, psychological health, social relationships, and environment.
Ranges of scores: depression: 0-27, anxiety: 0-4, panic: 0-4, PTSD: PTSD: 0-80., tobacco: 0-31, alcohol: 0-39, cannabis use: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogen: 0-39, opioid: 0-39, QOL physical health: 4-20, QOL psychological health: 4-20, QOL social relationships: 4-20, QOL environment: 4-20.
Higher scores mean worse outcomes for mental health symptoms and substance use scores; higher scores mean worse outcomes for quality of life measures.
26 months
Other Self-care Activities Five types of self-care activities to relieve stress: internet or mobile applications, community groups (church groups, gun clubs), community classes (Yoga, cooking), alternative treatments (acupuncture, chiropractor, massage), and other self-care activities (meditation, fishing, walking). 26 months
Primary 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 26 months
Secondary 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 26 months
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