Homecoming Line: Telephone Support for Veterans

NCT ID: NCT02655991

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-08-31

Brief Summary

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This study will determine whether telephone support improves clinical outcomes of veterans who begin outpatient treatment for posttraumatic stress disorder. Participants will be randomly assigned to receive either usual care or usual care supplemented by biweekly monitoring and support by telephone during the first 3 months of treatment. Patients in both conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking at 4 months and 12 months after entering treatment.

Detailed Description

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This multisite randomized controlled trial will test whether a 3-month period of providing telephone monitoring to PTSD patients as a supplement to usual specialty mental health care improves 12-month clinical outcomes (a reduction in PTSD symptoms, violence, and substance use). Secondarily, this study will determine whether telephone monitoring promotes better engagement in outpatient treatment (Number of mental health and psychotherapy visits during the 3-month intervention period).

Demand for VA PTSD treatment is increasing as troops return from combat deployments in Afghanistan and Iraq. Telemedicine is likely to be an important component in developing more effective and efficient models of PTSD care that improves patient functioning and treatment utilization. It is hoped that using telephone case monitoring as an inexpensive adjunct to standard care may improve clinical outcomes and reduce hospitalization among veterans with PTSD.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Telephone Case Monitoring

Telephone care management augmenting treatment as usual

Group Type EXPERIMENTAL

Telephone Case Monitoring

Intervention Type BEHAVIORAL

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.

Treatment as Usual

Intervention Type BEHAVIORAL

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

Treatment as Usual

Case management, psychotherapy, and pharmacotherapy as usual

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

Interventions

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Telephone Case Monitoring

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.

Intervention Type BEHAVIORAL

Treatment as Usual

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* VA patients newly entering outpatient treatment mental health treatment for PTSD starting a new phase of outpatient PTSD treatment (e.g., transitioning from a psycho-education group to active psychotherapy) at one of the study sites.

Exclusion Criteria

* Active duty personnel
* Cognitive impairment which precludes giving informed consent
* Initiating residential or inpatient treatment rather than outpatient treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Durham VA Medical Center

FED

Sponsor Role collaborator

VA Puget Sound Health Care System

FED

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Craig S. Rosen, Ph.D.

Deputy Director, National Center for PTSD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig S. Rosen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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VA Palo Alto Health Care System (Meno Park Division)

Menlo Park, California, United States

Site Status

Durham VA Medical Center

Durham, North Carolina, United States

Site Status

VA Puget Sound Health Care System (American Lake)

Lakewood, Washington, United States

Site Status

Countries

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United States

References

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Rosen CS, Azevedo KJ, Tiet QQ, Greene CJ, Wood AE, Calhoun P, Bowe T, Capehart BP, Crawford EF, Greenbaum MA, Harris AH, Hertzberg M, Lindley SE, Smith BN, Schnurr PP. An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatr Serv. 2017 Feb 1;68(2):151-158. doi: 10.1176/appi.ps.201600069. Epub 2016 Oct 17.

Reference Type DERIVED
PMID: 27745535 (View on PubMed)

Other Identifiers

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W81XWH=08-2-0096

Identifier Type: -

Identifier Source: org_study_id

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