NCT01893983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

June 21, 2013

Results QC Date

May 28, 2019

Last Update Submit

August 26, 2019

Conditions

Mental HealthRural HealthVeterans Health

Keywords

Mental HealthVeterans HealthRuralMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mental Health (MH) Treatment Retention

    26 months

Other Outcomes (2)

  • Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures.

    26 months

  • Self-care Activities

    26 months

Study Arms (2)

Motivational Coaching

EXPERIMENTAL

Telephone based Motivational Coaching sessions

Behavioral: Motivational Coaching

Referral alone

NO INTERVENTION

This is the current standard of care

Interventions

Motivational CoachingBEHAVIORAL

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

Motivational Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • 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.

    PMID: 27509291RESULT

  • 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. 2017 Sep;47:63-70. doi: 10.1016/j.healthplace.2017.07.001. Epub 2017 Jul 26.

    PMID: 28755653RESULT

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Dr. Karen Seal
Organization
San Francisco VA Healthcare System
karen.seal@va.gov
415-2214810

Study Officials

  • Karen H Seal, MD MPH

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 9, 2013

Study Start

October 1, 2015

Primary Completion

May 31, 2018

Study Completion

September 30, 2018

Last Updated

September 27, 2019

Results First Posted

September 27, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)