An interventional study of Motivational Coaching in Mental Health, Rural Health and Veterans Health, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Telephone based Motivational Coaching sessions
Behavioral: Motivational Coaching
This is the current standard of care
Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment
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
Time frame: 26 months
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
Time frame: 26 months
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.
Time frame: 26 months
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).
Time frame: 26 months
(1) CBOC providers will refer veterans; (2) VA administrative data will be used to identify veterans; (3) veteran self-referral; (4) "snowball sampling"
| Milestone | Motivational Coaching | Referral Alone |
|---|---|---|
| Started | 140 | 140 |
| Completed | 130 | 134 |
| Not completed | 10 | 6 |
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
| Participants | Motivational Coaching | Referral Alone |
|---|---|---|
| Mental Health (MH) Treatment Engagement | 78 | 74 |
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
| Participants | Motivational Coaching | Referral Alone |
|---|---|---|
| Mental Health (MH) Treatment Retention | 67 | 62 |
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.
| score on a scale | Motivational Coaching | Referral Alone |
|---|---|---|
| depression | 9.4 ± 6.2 | 11.1 ± 6.5 |
| anxiety | 1.2 ± 0.9 | 1.3 ± 0.8 |
| panic | 0.6 ± 0.9 | 0.7 ± 0.9 |
| PTSD | 25.1 ± 18.4 | 29.7 ± 16.7 |
| tobacco | 8.8 ± 9.5 | 9.2 ± 10.0 |
| alcohol | 7.1 ± 7.7 | 7.7 ± 8.6 |
| cannabis | 3.1 ± 4.8 | 4.6 ± 6.7 |
| cocaine | 0.7 ± 2.9 | 0.9 ± 2.5 |
| amphetamine | 0.3 ± 1.6 | 0.7 ± 2.5 |
| inhalants | 0 ± 0 | 0.2 ± 1.4 |
| sedatives | 0.5 ± 2.9 | 0.8 ± 3.1 |
| halluninogens | 0.2 ± 1.1 | 0.2 ± 0.8 |
| opioid | 0.5 ± 2.7 | 0.9 ± 3.8 |
| QOL physical health domain | 12.6 ± 3.7 | 12.0 ± 3.1 |
| QOL psychological health domain | 13.4 ± 2.8 | 12.7 ± 2.5 |
| QOL social relationships domain | 13.3 ± 3.9 | 12.1 ± 3.8 |
| QOL environment domain | 14.4 ± 2.5 | 13.6 ± 2.6 |
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).
| Participants | Motivational Coaching | Referral Alone |
|---|---|---|
| Internet or mobile applications | 84 | 63 |
| Community groups | 59 | 52 |
| Community classes | 31 | 16 |
| Alternative treatments | 40 | 38 |
| Self-care activities | 111 | 109 |
Collected over 2 years and 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motivational Coaching | 0/140 (0%) | 3/140 (2.1%) | 4/140 (2.9%) |
| Referral Alone | 0/140 (0%) | 2/140 (1.4%) | 2/140 (1.4%) |
| Event | Motivational Coaching | Referral Alone |
|---|---|---|
| Hospitalization from Car AccidentInjury, poisoning and procedural complications | 1/140 | 0/140 |
| Hospitalization from Stomach FluGastrointestinal disorders | 0/140 | 1/140 |
| Hospitalization for Lung TransplantRespiratory, thoracic and mediastinal disorders | 1/140 | 0/140 |
| Hospitalization for Abdominal SurgerySurgical and medical procedures | 0/140 | 1/140 |
| Hospitalization due to injuryInjury, poisoning and procedural complications | 1/140 | 0/140 |
| Event | Motivational Coaching | Referral Alone |
|---|---|---|
| Lung Cancer DiagnosisRespiratory, thoracic and mediastinal disorders | 0/140 | 1/140 |
| Hurt ShoulderInjury, poisoning and procedural complications | 0/140 | 1/140 |
| Recently illnessInfections and infestations | 1/140 | 0/140 |
| Adverse Events related to PTSDPsychiatric disorders | 1/140 | 0/140 |
| Broken RibInjury, poisoning and procedural complications | 1/140 | 0/140 |
| AnxietyPsychiatric disorders | 1/140 | 0/140 |
We baselined 418 participants, 280 were eligible for the study and randomized.
| Age, Continuous(years) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| Mean | 50.1 ± 13.1 | 51.2 ± 13.8 | 50.7 ± 13.4 |
| Sex: Female, Male(Participants) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| Female | 27 | 17 | 44 |
| Male | 112 | 123 | 235 |
| Ethnicity (NIH/OMB)(Participants) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 13 | 20 |
| Not Hispanic or Latino | 131 | 127 | 258 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 5 | 3 | 8 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 28 | 36 | 64 |
| White | 87 | 76 | 163 |
| More than one race | 8 | 9 | 17 |
| Unknown or Not Reported | 8 | 15 | 23 |
| Region of Enrollment(Participants) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| United States | 139 | 140 | 279 |
| WHOQOL-BREF(units on a scale) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| Physical Health | 12.0 ± 3.7 | 11.9 ± 3.3 | 12.0 ± 3.5 |
| Psychological Health | 13.3 ± 3.1 | 12.9 ± 2.6 | 13.1 ± 2.8 |
| Social Relationships | 13.0 ± 4.2 | 12.7 ± 4.0 | 12.8 ± 4.1 |
| Environment | 14.6 ± 2.9 | 14.1 ± 2.9 | 14.3 ± 2.9 |
| Mental Health Treatment Experiences in the last 5 years(Participants) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| Primary Care | 50 | 43 | 93 |
| Mental Health- Individual or Group Counseling | 73 | 76 | 149 |
| Substance Abuse Treatment | 8 | 12 | 20 |
| Inpatient Psychiatric Treatment | 5 | 5 | 10 |
| Counseling by Social Worker | 19 | 18 | 37 |
| Counseling by chaplain or other religious person | 6 | 10 | 16 |
| Marital, relationship or family counseling | 13 | 8 | 21 |
| Self-help group | 10 | 5 | 15 |
| Internet/Mobile Application treatment program/supp | 9 | 10 | 19 |
| Telephone counseling program | 10 | 16 | 26 |
| Psychiatric medication | 81 | 85 | 166 |
| Research study | 7 | 4 | 11 |
| Readiness Ruler: Assessment of Motivation for Treatment(units on a scale) | Motivational Coaching | Referral Alone | Total |
|---|---|---|---|
| How important is it for you to receive treatment r | 5.2 ± 3.1 | 5.9 ± 3.5 | 5.5 ± 3.3 |
| How confident are you that you would get treatment | 5.9 ± 3.4 | 6.4 ± 3.3 | 6.1 ± 3.4 |
| How ready are you to receive treatment right now f | 6.2 ± 3.3 | 6.9 ± 3.4 | 6.6 ± 3.4 |
5 further baseline measures are reported on the registry.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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