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Telephone-Based Care for OEF/OIF Veterans With PTSD
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, March 2009
First Received: May 16, 2008   Last Updated: March 26, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680524
  Purpose

Objective: OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD.

Research Plan:

This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.


Condition Intervention
Post-Traumatic Stress Disorder
Other: Phone-based outreach

MedlinePlus related topics: Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Telephone Based Care for OIF/OEF Veterans With PTSD

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Acceptability to providers and patients [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Open pilot trial
Other: Phone-based outreach
Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD

Detailed Description:

Background:

OEF/OIF (Operation Enduring Freedom and Operation Iraqi Freedom) veterans are presenting with high rates of PTSD. Translating Initiatives for Depression into Effective Solutions (TIDES) is a model of phone-based care being implemented nationally as a model to address those patients suffering from depression, PTSD, or alcohol use disorders. However, evidence-based treatments do not yet exist for phone-based management of OEF/OIF veterans who suffer from PTSD.

Objectives:

This is an open trial to assess feasibility of augmenting standard treatment of PTSD with TIDES based telephone-based nurse care management.

Methods:

Methodology:

Setting: The Deployment Health Clinic (DHC) at the Seattle VA Puget Sound Health Care System (PSHCS) is an integrated primary care mental health clinic.

Two registered nurses who are experienced using the TIDES model will join the DHC staff.

Usual Care: All OEF/OIF veterans who present for care to the Seattle PSHCS are typically referred to the DHC for initial evaluation. Patients receive primary care by DHC providers. Mental health providers within the DHC provide evidence-based pharmacological and psychotherapeutic interventions.

Intervention: 20 consecutive patients who are initiating treatment at the DHC and who are diagnosed with PTSD or PTSD with a comorbid major depressive disorder will be recruited. The phone-based care will be considered an augmentation to care as usual by DHC staff. Nurse Care Managers will follow the TIDES templates adapted with questions that focus on management of PTSD. Phone-based care for PTSD will focus on evaluation and monitoring three clinical domains related to the management of PTSD: (1) Improving coping mechanisms and symptom reduction: Nurse Care Managers will supply participants with the workbook Strategies for managing Stress After the War: Veterans Workbook. Nurse Care Managers will direct participants to read relevant chapters that address their specific symptoms and coping mechanisms. (2) Medication management: This proposal will adapt TIDES medication algorithms for those patients with major depressive disorders to include medications commonly used to treat PTSD. (3) Psychosocial support: Many patients OEF/OIF veterans face significant psychosocial stressors (lack of employment, poor housing, and family stress). A list of common social work resources as created by the DHC social worker will be provided to the Nurse Care Mangers. Subjects will complete a full six months of treatment using this phone based model of care. It is anticipated that subjects will remain in treatment beyond the mandatory project conclusion date.

Status:

Activities are ongoing. To date the study has accomplished the following: 1) Created phone templates that are compatible to those used by TIDES; 2) Created the templates so that they automatically collect and store real-time outcome data while the nurses work on the phone; 3) Identified and employed a workbook that is compatible with PTSD symptoms that the nurses can use over the phone; 4) Educated the Deployment Health Clinic on the program and showed that we can recruit subjects; 5) Created qualitative and quantitative interviews for both subjects and staff; and 6) Created a data base to track all proposed outcomes

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PTSD
  • Operation Enduring Freedom and Operation Iraqi Freedom veteran

Exclusion Criteria:

  • no phone
  • severe brain injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680524

Contacts
Contact: Bradford L Felker, MD (206) 277-1191 bradford.felker@med.va.gov

Locations
United States, Washington
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Bradford L Felker, MD     206-277-1191     bradford.felker@med.va.gov    
Principal Investigator: Bradford L. Felker, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Bradford L. Felker, MD VA Puget Sound Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Felker, Bradford - Principal Investigator )
Study ID Numbers: SHP 08-184
Study First Received: May 16, 2008
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00680524     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telephone-based intervention for PTSD

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009