NCT01554839

Brief Summary

The purpose of this study is to evaluate the effectiveness of a unique web based educational tool called "Family of Heroes," which is designed to educate families about Post Traumatic Stress Disorder (PTSD) and provide them with practical tools for interacting with affected veteran family members. The study includes veterans and a family member of their choosing. Participants are randomly assigned to a group which takes the online training or a group that does not take the training. Both groups complete a baseline questionnaire and a follow up questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental health visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

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

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 10, 2015

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

March 5, 2012

Last Update Submit

February 9, 2015

Conditions

Post Traumatic Stress DisorderPTSD

Outcome Measures

Primary Outcomes (1)

  • Mental Health Treatment Engagement

    Number of mental health visits attended. Obtained from chart review.

    6 months post enrollment

Secondary Outcomes (2)

  • Change in Perceived Criticism Score

    Baseline and 2 months

  • Change in Family Empowerment Scale Score

    Baseline and 2 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys

Behavioral: "Family of Heroes"Behavioral: Baseline and Follow up Surveys

Non Treatment Group

PLACEBO COMPARATOR

Non Treatment group participates in baseline and follow up surveys

Behavioral: Baseline and Follow up Surveys

Interventions

"Family of Heroes"BEHAVIORAL

One hour online educational tool

Treatment Group
Baseline and Follow up SurveysBEHAVIORAL

Baseline and follow up questionaires completed online

Non Treatment GroupTreatment Group

Eligibility Criteria

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

You may qualify if:

  • Male or female Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) veteran
  • Positive for PTSD, based on PTSD Checklist (PCL) score greater than or equal to 50
  • Availability of a family member who is both willing to participate in the study AND has contact with the veteran 3 or more times per week
  • Ability to access a computer with internet access to take educational training and surveys

You may not qualify if:

  • Not and OIF/OEF veteran
  • Negative for PTSD, based on PCL score less than 50
  • Unavailability of a family member who is both willing to participate in the study or has contact with the veteran 3 or more times per week
  • Inability to access a computer with internet access to take the educational training and surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VANJHCS (Veterans Administration New Jersey Health Care Services)

Lyons, New Jersey, 07939, United States

Location

Related Publications (1)

  • Interian A, Kline A, Perlick D, Dixon L, Feder A, Weiner MD, Goldstein MF, Hennessy K, St Hill L, Losonczy M. Randomized controlled trial of a brief Internet-based intervention for families of Veterans with posttraumatic stress disorder. J Rehabil Res Dev. 2016;53(5):629-640. doi: 10.1682/JRRD.2014.10.0257.

    PMID: 27898154DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Alejandro Interian, PhD

    Department of Veteran Affairs, New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 15, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 10, 2015

Record last verified: 2013-06

Locations

US(1)