Innovative Service Delivery for Secondary Prevention of PTSD

September 11, 2015 updated by: Charleston Research Institute

Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

The purpose of this study is to determine whether therapy for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) veterans with Post-traumatic Stress Disorder (PTSD) symptoms can be delivered effectively using videoconferencing technology ("telepsychology"), which allows a therapist and patient who are not in the same room as one another to communicate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OIF and OEF service men and women exposed to high levels of violence are at risk for developing mental health disorders including Post-traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Even those with less severe symptoms who fail to meet diagnostic criteria for a mental health disorder may struggle to return to pre-deployment functioning. Studies suggest that a significant percentage of veterans may suffer from "subthreshold" PTSD; although their symptom presentation is less severe, these veterans experience emotional distress and reduced quality of life.

Given that Veterans Affairs (VA) mental-health service providers are faced with the important and challenging task of alleviating the emotional suffering of our service men and women while staying within budget confines, we need effective, practical, evidence-based treatments that can be delivered in an expedient and cost-effective manner. Thus, the current project has two primary objectives: 1) to develop, implement, and evaluate a treatment program (Behavioral Activation and Therapeutic Exposure, BATE) for OIF and OEF veterans with PTSD symptoms, and 2) to determine whether or not this program delivered via telepsychology will be as effective as in-person treatment. Secondary objectives include determining: 1) which treatment modality is more effective in terms of process variables (e.g., treatment satisfaction, session attendance), 2) which treatment modality is more cost-effective, and 3) whether treatment effects differ across race and gender. Study participants will be randomized to two treatment conditions, BATE delivered via telepsychology (BATE-T) and BATE delivered in-person (BATE-IP).

The current treatment protocol is based on two, research-supported therapeutic rationales, Behavioral Activation (BA) and Therapeutic Exposure (TE). Briefly, the treatment aims to increase the participant's engagement in healthy activities (i.e., activities that are naturally reinforcing and promote the participant's life values) and exposure activities (i.e., activities that target specific PTSD symptoms such as avoidance and hyperarousal). Treatment will be implemented in eight, one and half hour sessions. Although research supports the effectiveness of behavior- and exposure-based treatments for trauma-related mental health problems, a potential risk for any counseling program that targets avoidance symptoms is a temporary increase in emotional distress. Therapists will inform participants that this is a normal "side effect" of treatment. However, over the course of treatment should a participant's emotional distress rise to a level above what can be handled via outpatient counseling, the participant will be removed from the study and appropriate referrals will be made.

The anticipated duration of this study is four years. Based on results of the study, we will finalize the treatment manual. In terms of clinical applicability, we plan to present study findings at conferences and disseminate the treatment manual to VA mental health service providers in approximately four to five years. Study findings will address important gaps in the PTSD literature, yielding several contributions to the field. First, to the extent that BATE effectively reduces symptom severity, this investigational treatment may benefit individual OIF/OEF service men and women by alleviating emotional suffering and improving quality of life. Second, to the extent that BATE prevents the development of full-blown PTSD in subclinical military personnel, this investigational treatment may reduce attrition from the military due to untreated mental health problems. Third, only a small percentage of those who might benefit from counseling actually seek services due to barriers associated with traditional service delivery practices such as geographic distance from the VA hospital and stigma of psychological treatment. Thus, as telemedicine has been shown to circumvent these barriers to care, the current project has the potential to reach an otherwise underserved population: subclinical OIF and OEF service men and women who may be reluctant to seek care. Fourth, to the extent that BATE-T produces results comparable to BATE-IP, this study may potentially identify a cost-effective alternative to in-person treatment thereby reducing post-service treatment costs to VA's.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29403
        • Ralph H. Johnson VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will be OIF/OEF military personnel,
  • age 21 and above, and
  • with symptoms of posttraumatic stress disorder (PTSD) assigned on the basis of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M).

Exclusion Criteria:

  • Actively psychotic or demented persons,
  • individuals with both suicidal ideation and clear intent, and
  • individuals meeting criteria for substance dependence will be excluded from participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BATE-T
Behavioral Activation Therapeutic Exposure done while the patient is at home via videoconferencing technology
Behavioral: Behavioral Activation Therapeutic Exposure (BATE)
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
Active Comparator: BATE-IP
Behavioral Activation Therapeutic Exposure done in the therapist's office
Behavioral: Behavioral Activation Therapeutic Exposure (BATE)
This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The major objective of this study is to determine if Behavioral Activation with Therapeutic Exposure (BATE) delivered via Telemedicine is as effective as BATE In Person.
Time Frame: 1 year
This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline
Baseline
Beck Depression Inventory-II (BDI-II)
Time Frame: 3 months
3 months
Clinician Administered PTSD Scale (CAPS)
Time Frame: 8 weeks
8 weeks
Clinician Administered PTSD Scale (CAPS)
Time Frame: Baseline
Baseline
Clinician Administered PTSD Scale (CAPS)
Time Frame: 3 months
3 months
Clinician Administered PTSD Scale (CAPS)
Time Frame: 1 year
1 year
The Deployment Risk and Resiliency Inventory (DRRI)
Time Frame: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Time Frame: Baseline
Baseline
PTSD Checklist-Military (PCL-M)
Time Frame: 4 weeks
4 weeks
PTSD Checklist-Military (PCL-M)
Time Frame: 8 weeks
8 weeks
PTSD Checklist-Military (PCL-M)
Time Frame: 3 months
3 months
PTSD Checklist-Military (PCL-M)
Time Frame: 1 year
1 year
Beck Depression Inventory-II (BDI-II)
Time Frame: 4 weeks
4 weeks
Beck Depression Inventory-II (BDI-II)
Time Frame: 8 weeks
8 weeks
Beck Depression Inventory-II (BDI-II)
Time Frame: 1 year
1 year
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Time Frame: Baseline
Baseline
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Time Frame: 4 weeks
4 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Time Frame: 8 weeks
8 weeks
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Time Frame: 3 months
3 months
Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36)
Time Frame: 1 year
1 year
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Time Frame: 8 weeks
8 weeks
Service Delivery Perceptions Questionnaire
Time Frame: 8 weeks
8 weeks
Prior Experience with Computer and Audiovisual Technology
Time Frame: Baseline
Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charleston Research Institute

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Ronald Acierno, PhD, VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DoD Acierno

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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