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| ID | Type | Description | Link |
|---|---|---|---|
| C.2012.184d | Other Identifier | BAMC Institutional Review Board | |
| W81XWH-08-2-0109 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| San Antonio Military Medical Center | FED |
| 59th Medical Wing | FED |
| Wright State University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment | Experimental | Four 30-minute sessions of Brief Cognitive Behavioral treatment starting immediately upon randomization. |
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| Minimal Contact followed by treatment | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Behavioral Treatment | Behavioral | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan L Peterson, PhD, ABPP | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Ambulatory Surgical Center Family Medicine Clinic | Lackland Air Force Base | Texas | 78236 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29283612 | Derived | Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315. |
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| Minimal Contact | Behavioral | 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. |
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| Joint Base San Antonio |
| Randolph Air Force Base |
| Texas |
| 78148 |
| United States |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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