Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings

Study Overview
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Brief Summary
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A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics. A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. The purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. The primary outcome measure is PTSD symptom relief.

Detailed Description
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A significant number of veterans of the wars in Iraq and Afghanistan are affected by posttraumatic stress disorder (PTSD) yet relatively few are receiving evidence-based treatments (Tanielian, Jaycox, Schell, Marshall, Burnham, Eibner, et al. 2008). The limited reach of effective treatments for PTSD into the veteran population is at least partially due to the perceived stigma by service members for seeking help in traditional specialty mental health clinics (Hoge, Castro, Messer, McGurk, Cotting, & Koffman, 2004). A comprehensive approach to PTSD treatment in a veteran population should provide alternative sources for accessing effective psychotherapy treatments. This study builds upon a pilot study conducted at Brooke Army Medical Center and the Wilford Hall Medical Center (now the Wilford Hall Ambulatory Surgical Center) (C.2009.022, IRBNet 363516). Using the treatment protocol developed and found to be effective as part of this pilot, the purpose of study is to conduct a randomized clinical trial comparing a brief (four 30-minute sessions delivered over 6 weeks) cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants working in an integrated primary care setting to a minimal contact 6-week control. Up to 75 Service Members with deployment-related PTSD symptoms will be consented, enrolled, and treated until treatment has been completed for 60. The primary outcome measure is PTSD symptom relief. OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS: Will Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn (OIF/OEF/OND) veterans with PTSD symptoms accept an offer of cognitive behavioral therapy (CBT) treatment in the primary care setting versus a referral to specialty care? Will a brief (four 30-minute appointments) CBT protocol designed for use by behavioral health consultants working in primary care significantly reduce PTSD symptom severity in OIF/OEF/OND veterans in comparison to a minimal contact condition? Are there characteristics of patients at pre-treatment, e.g., demographic variables, level of co-morbid depression, that predict a relatively better or worse response to PTSD treatment in primary care?

Official Title
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Brief Cognitive Behavioral Treatment of Deployment-Related PTSD Symptoms in Primary Care Settings: A Randomized Controlled Trial

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Brief Cognitive Behavioral Treatment
* Behavioral: Minimal Contact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: active duty, reserve, guard, separated, or retired OIF/OEF/OND veterans seeking care in primary care for deployment-related PTSD symptoms Symptomatic for PTSD will be defined as a minimum score of 32 on the PTSD CheckList -Stressor-specific (PCL-S) English speaking If individuals are taking psychotropic medication, a 4-week stabilization period may be required prior to enrollment, depending upon the medication, half-life, and anticipated interaction with the ability to engage in behavioral therapy Exclusion Criteria: moderate to severe suicide risk current alcohol dependence, psychotic disorder, significant dissociative disorder severe brain injury Patients who are currently receiving talk therapy for trauma-related symptoms will also be excluded

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>Four 30-minute sessions of Brief Cognitive Behavioral treatment starting immediately upon randomization. | Behavioral: Brief Cognitive Behavioral Treatment<br>* Cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy.<br>|
| Active Comparator: Minimal Contact followed by treatment<br>6-week Minimal Contact period consisting of weekly phone calls starting immediately upon randomization. Experimental treatment will be provided to all subjects upon completion of Minimal Contact period. | Behavioral: Brief Cognitive Behavioral Treatment<br>* Cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy.<br>Behavioral: Minimal Contact<br>* Participants assigned to minimal contact (MC) will be asked to not work with another therapist or seek additional treatment for trauma-related difficulties during the 6-week MC period. They will be called once per week by the Behavioral Health Consultant (BHC) in order to monitor their status and to provide support as needed. The calls will be limited to 5-10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Scale, Interview Version (PSS-I); to assess change in PTSD symptomatology and/or diagnosis from baseline to multiple follow up time points | The PSS-I is a 20-minute, 17-item clinical interview that evaluates each of the DSM-IV PTSD symptoms during the past 2 weeks on a frequency/severity scale (Foa, Riggs, Dancu, & Rothbaum, 1993). The PSS-I is comparable to the gold standard employed in studies of veterans (the Clinician Administered PTSD Scale; CAPS) yet takes considerably less time to administer (Foa & Tolin, 2000). Each symptom is rated on a 4-point scale ranging from 0 (not at all) to 3 (very much). Subscale scores are calculated by summing items in each of the PTSD symptom clusters: re-experiencing, avoidance, and arousal. The scale has excellent internal consistency (α = .85), test-retest reliability (.80), and inter-rater reliability (kappa = .97; Foa et al, 1993). This measure will be administered by a blinded Independent Evaluator at each study site. | Baseline, 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx | 
| PTSD Checklist - Stressor-Specific Version (PCL-S); to assess change in PTSD symptomatology from baseline throughout treatment and at multiple follow up time points | The PCL-S is a 17 item self-report measure based upon the PTSD Checklist - Military (PCL-M; Weathers, Litz, Herman, Huska, & Keane, 1993) that evaluates how much participants have been bothered by PTSD symptoms in the past month as a result of the stressful life events identified by either the participant, or by the Independent Evaluator following administration of the PSS-I. Each item of the PCL-S is scored on a five-point scale ranging from 1 (-not at all‖) to 5 (-extremely‖). The measure is divided into 3 subscales: Re-experiencing symptoms (items 1- 5); Avoidance/ Emotional Numbing symptoms (items 6- 12); and Hyper-arousal symptoms (items 12-17). | Baseline, Weekly during treatment (4 time points), 2 weeks post-tx, 8 weeks post-tx, 6 months post-tx | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress, Posttraumatic Stress Disorder, Military, Primary Care, Cognitive Behavioral Therapy, Prolonged Exposure, Cognitive Processing Therapy, Behavioral Health Optimization Program, Behavioral Health Consultant