Innovative Service Delivery for Secondary Prevention of PTSD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Behavioral Activation Therapeutic Exposure (BATE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Military, Health Service Delivery, Behavioral Symptoms, Telepsychology, Behavioral Activation, Exposure Therapy, Veterans, Telemedicine