Trial record 5 of 16 for:    PTSD AND military and (woman OR women OR female)

Innovative Service Delivery for Secondary Prevention of Post-traumatic Stress Disorder (PTSD) in At-Risk OIF-OEF Service Men and Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Charleston Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Charleston Research Institute
ClinicalTrials.gov Identifier:
NCT01177488
First received: April 12, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Mental Health
PTSD
Behavioral: Behavioral Activation Therapeutic Exposure (BATE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Innovative Service Delivery for Secondary Prevention of PTSD in At-Risk OIF-OEF Service Men and Women

Resource links provided by NLM:


Further study details as provided by Charleston Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    This is measured in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes.

  • Treatment Credibility [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess for differences in outcome expectancy, treatment credibility scales developed by Borkovec and Nau (1972) will be used. Four of the questions will be used for this study, with 10-point Likert scales. These include questions regarding how logical treatment seems, how confident they are about treatment, and expectations of success.


Secondary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The Deployment Risk and Resiliency Inventory (DRRI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PTSD Checklist-Military (PCL-M) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Service Delivery Perceptions Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Prior Experience with Computer and Audiovisual Technology [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Short measure to learn more about participants' prior experience and comfort level with computers and audiovisual technology


Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177488

Contacts
Contact: Martha Strachan, PhD 843-792-2949 stracham@musc.edu
Contact: Ronald Acierno, PhD 843-792-2949 acierno@musc.edu

Locations
United States, South Carolina
Ralph H. Johnson VAMC Recruiting
Charleston, South Carolina, United States, 29403
Contact: Martha Strachan, PhD    843-792-2949    stracham@musc.edu   
Principal Investigator: Ronald Acierno, PhD         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Martha Strachan, PhD    843-792-2949    stracham@musc.edu   
Principal Investigator: Thomas Uhde, MD         
Sponsors and Collaborators
Charleston Research Institute
Investigators
Principal Investigator: Ronald Acierno, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Kelsie H. Cochran/Executive Director, Charleston Research Institute
ClinicalTrials.gov Identifier: NCT01177488     History of Changes
Other Study ID Numbers: DoD Acierno
Study First Received: April 12, 2010
Last Updated: August 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Charleston Research Institute:
Military
Health Service Delivery
Behavioral Symptoms
Telepsychology
Behavior Activation
Exposure Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014