NCT00680524

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

September 26, 2014

Completed
Last Updated

April 28, 2015

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 16, 2008

Results QC Date

June 25, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

telephone-based intervention for PTSD

Outcome Measures

Primary Outcomes (1)

  • Acceptability to Providers and Patients

    Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below

    Six months

Study Arms (1)

Phone Based Outreach Intervention Group

EXPERIMENTAL

Open pilot trial

Other: Phone-based outreach

Interventions

Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD

Phone Based Outreach Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD
  • Operation Enduring Freedom and Operation Iraqi Freedom veteran

You may not qualify if:

  • no phone
  • severe brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Bradford Felker, MD
Organization
VA Puget Sound Health Care System

Study Officials

  • Bradford L. Felker, MD BA

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 28, 2015

Results First Posted

September 26, 2014

Record last verified: 2014-06

Locations