Clinical Trials Logo

Clinical Trial Summary

This project will add an evaluation/research component to an existing peer outreach program, now implemented for over 1100 soldiers in the Michigan Army National Guard. Preliminary work will be completed in three areas. We will conduct semi-structured interviews with soldiers, Buddies, and National Guard leadership and develop and pilot test survey items relevant to implementation. Further, we will develop and pretest survey items relevant to determining soldier symptomatic and functional status. We will also conduct a small feasibility study, fielding the newly developed survey to a representative sample of recently returned National Guard members from Michigan and Indiana, to determine response rates and veteran willingness to allow access to linkable PDHA/PDHRA data and health services data. Finally, we will construct a merged, de-identified longitudinal dataset comprised of Post-Deployment Health Assessment and Reassessment data, Military Health System/TRICARE, and VA services data from National Guard soldiers in Michigan and comparison states of Indiana and Ohio. This will allow a longitudinal assessment of services initiation and retention for the entire Guard populations in these states.


Clinical Trial Description

Background:

Soldiers returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) commonly experience symptoms of PTSD, depressive disorders, and interpersonal difficulties. Forty-two percent of National Guard (NG) soldiers report symptoms suggesting a need for evaluation. Unfortunately, only half with mental health needs initiate treatment in the VA or elsewhere. Stigma remains an important barrier. Proactive peer outreach may successfully address stigma and facilitate appropriate treatment use. In the recently implemented Michigan Guard Buddy*to*Buddy (B2B) program, all returning MIARNG soldiers are assigned a first-tier "Buddy" from their unit who systematically telephones them to "check in" regarding key areas of functioning and symptoms. Soldiers may also be referred to second-tier Buddies, veterans outside the Guard trained in motivational interviewing and supervised by professional staff. The goal of the program is to identify soldiers in need of evaluation and connect them to care in a timely fashion.

We will conduct preliminary work that will allow us to assess the need for and the feasibility of adding a rigorous evaluation/research component to the B2B program.

Objectives:

The goal of this RRP is to assess the need for AND the feasibility of a larger VA study that would use a strong quasi-experimental design (time series analysis with comparison groups) to examine the impact of the B2B program on returning NG veteran mental health treatment initiation, retention, symptoms, and functional outcomes.

Specific RRP aims are to:

1. Prepare for and initiate a formative evaluation of the Buddy*to*Buddy program in the Michigan Army National Guard (MI ARNG).

2. Develop and determine the feasibility of a confidential surveys for National Guard veterans in Michigan and Indiana that elicit information regarding B2B processes (in MI ARNG), VA outreach processes, mental health symptoms, substance use, and treatment initiation and retention.

3. Construct a de-identified linked dataset consisting of PDHA/PDHRA data, Military Treatment Facility/TRICARE service provider use, and VA service use for MI ARNG and NG soldiers in contiguous states of Indiana and Ohio. Conduct preliminary analyses of these data.

Methods:

Preliminary work will be completed in two areas. We will begin a formative evaluation of the implementation of the B2B program, using an augmented qualitative RE-AIM Plus framework, multiple data sources and data collection techniques, and conducting field observations and interviews with program stakeholders. Personnel at all levels, including NG leadership, Buddies, and soldiers, will be part of this process.

We will also develop and refine survey items relevant to understanding B2B implementation and soldier symptom and functional status. We will test procedures for fielding this survey in Michigan and a comparison state, assessing response rates, and using data to inform the design of a larger study of soldier outcomes. ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT01020981
Study type Observational
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date January 2010
Completion date December 2011

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A