NCT01984515

Brief Summary

The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

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

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 16, 2015

Completed
Last Updated

December 16, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

November 7, 2013

Results QC Date

September 23, 2015

Last Update Submit

November 10, 2015

Conditions

Keywords

Post-traumatic Stress DisorderEvidence-Based PsychotherapyTreatment EngagementCognitive Behavioral TherapyImplementation Science

Outcome Measures

Primary Outcomes (1)

  • Engagement in Evidence-based Psychotherapy for PTSD

    Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.

    From initiation of the Referral Management System to 6 months after initiation

Secondary Outcomes (2)

  • PTSD Checklist-Specific

    Referral Management Initiation, 1 month post initiation, 3 months post initiation

  • Patient Health Questionnaire-9 Item

    Referral Management Initiation, 1 month post initiation, 3 months post initiation

Study Arms (1)

Team Red Primary Care

EXPERIMENTAL

Eligible patients will receive the Referral Management System in primary care

Behavioral: Referral Management System

Interventions

Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.

Team Red Primary Care

Eligibility Criteria

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

You may qualify if:

  • Team Red primary care patients,
  • have a score of at least 44 on PCL-S and
  • able to give informed consent.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, 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
Dr. Kyle Possemato
Organization
Center for Integrated Healthcare

Study Officials

  • Kyle Possemato, PhD

    Syracuse VA Medical Center, Syracuse, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

December 16, 2015

Results First Posted

December 16, 2015

Record last verified: 2015-11

Locations