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| Name | Class |
|---|---|
| The Robert W. Woodruff Foundation | OTHER |
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The open-label clinical study explores potential modifiable predictors of treatment outcomes in a sample of 55 military service members and veterans with clinically significant PTSD symptoms who receive Intensive Outpatient Prolonged Exposure (IOP-PE).
Intensive Outpatient Prolonged Exposure (IOP-PE) is a three-week, intensive, individualized program that combines massed Prolonged Exposure with military-relevant treatment augmentations to treat posttraumatic stress disorder (PTSD; Peterson et al., 2018). Recent findings indicate that IOP-PE significantly decreased combat-related PTSD in post-9/11 service members and veterans (Peterson et al., 2019). However, IOP-PE is costly and requires a considerable commitment from the patient. Being able to prospectively identify which patients benefit most from IOP-PE will help treatment providers and patients make well-informed decisions about clinical care. The primary aim of this prospective, exploratory clinical study is to investigate potential predictors of treatment outcome following 15 sessions of IOP-PE delivered over 3-weeks in a sample of 55 military service members and veterans (i.e., individuals who have retired or separated from the US Armed forces, active duty personnel, reservists, and National Guardsmen/women) with significant PTSD symptoms. A follow-up assessment will be conducted one-month following the completion of treatment.
Predictor variables will include the following:
Aim 1: The PTSD Beliefs Inventory, the Dispositional Resilience and Disability Inventory, and the Credibility/ Expectancy Questionnaire.
Aim 2: The Disability-Recovery Implicit Association Test.
Aim 3: The Treatment Motivation Questionnaire and Service Connection Status
Aim 4: The Insomnia Severity Index, the Dimension of Anger Reactions-5, Patient Health Questionnaire-9, the Quick Drinking Screen, and the Pain Intensity, Enjoyment, and General Activity (PEG) Scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Outpatient Program - Prolonged Exposure | Other | Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks plus seven augmentations designed to maximize treatment outcomes. If necessary, the treatment window may be extended for another week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Outpatient Program - Prolonged Exposure | Behavioral | Prolonged Exposure for Posttraumatic Stress Disorder (PE for PTSD; Foa, Hembree, & Rothbaum, 2007) is an empirically supported behavioral therapy that utilizes exposure-based interventions to target the psychological mechanisms (i.e., avoidance; maladaptive cognitive changes) thought to maintain trauma-related symptoms. IOP-PE includes 15 days of PE treatment delivered over three consecutive weeks. The standard outpatient PE protocol has modified with seven treatment augmentations to meet the unique needs of post-9/11 veterans. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptoms | Change in scale measurements by the Clinician Administered PTSD Scale (CAPS-5). The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms) | Baseline and 1 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Peterson, PhD, ABPP | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30055335 | Background | Peterson AL, Foa EB, Blount TH, McLean CP, Shah DV, Young-McCaughan S, Litz BT, Schobitz RP, Castillo DT, Rentz TO, Yarvis JS, Dondanville KA, Fina BA, Hall-Clark BN, Brown LA, DeBeer BR, Jacoby VM, Hancock AK, Williamson DE, Evans WR, Synett S, Straud C, Hansen HR, Meyer EC, Javors MA, Sharrieff AM, Lara-Ruiz J, Koch LM, Roache JD, Mintz J, Keane TM; Consortium to Alleviate PTSD. Intensive prolonged exposure therapy for combat-related posttraumatic stress disorder: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2018 Sep;72:126-136. doi: 10.1016/j.cct.2018.07.016. Epub 2018 Jul 25. | |
| 29362795 |
| Label | URL |
|---|---|
| STRONG STAR website | View source |
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| 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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This is a prospective, one-group, exploratory clinical study.
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| Background |
| Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242. |