Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00680524 |
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 |
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 |
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
|
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
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bradford L Felker, MD | (206) 277-1191 | bradford.felker@med.va.gov |
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 |
Principal Investigator: | Bradford L. Felker, MD | VA Puget Sound Health Care System |
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 |
telephone-based intervention for PTSD |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |