Posttraumatic Stress Disorder (PTSD) Clinical Trial
Official title:
Project Remission: Maximizing Outcomes With Intensive Treatments for Combat-Related Posttraumatic Stress Disorder
Verified date | August 2022 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study compares two intensive outpatient behavioral programs (Massed Prolonged Exposure versus Intensive Outpatient Prolonged Exposure) for the treatment of posttraumatic stress disorder (PTSD) in post-9/11 active duty service members and veterans. The researchers hope to learn if these programs improve treatment outcomes. The researchers predict that Intensive Outpatient Prolonged Exposure (IOP-PE) will be better at treating PTSD than Massed-Prolonged Exposure (Massed PE).
Status | Completed |
Enrollment | 234 |
Est. completion date | May 1, 2021 |
Est. primary completion date | November 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Active duty military service member or veteran (age 18- 65 years) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD. 2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5). 3. Able to speak and read English (due to standardization of outcome measures) Exclusion Criteria: 1. Current manic episode or a psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the MINI). 2. Current and severe alcohol use warranting immediate intervention based on clinical judgment. 3. Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires). 4. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider) 5. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment. |
Country | Name | City | State |
---|---|---|---|
United States | Carl R. Darnall Army Medical Center | Fort Hood | Texas |
United States | Brooke Army Medical Center | San Antonio | Texas |
United States | South Texas Veterans Health Care System | San Antonio | Texas |
United States | Central Texas Veterans Health Care System | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Brooke Army Medical Center, C.R.Darnall Army Medical Center, Central Texas Veterans Health Care System, South Texas Veterans Health Care System, University of Pennsylvania, VISN 17 Center of Excellence |
United States,
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author. 2013.
Bisson JI, Ehlers A, Matthews R, Pilling S, Richards D, Turner S. Psychological treatments for chronic post-traumatic stress disorder. Systematic review and meta-analysis. Br J Psychiatry. 2007 Feb;190:97-104. Review. — View Citation
Blount TH, Cigrang JA, Foa EB, Ford HL, Peterson, AL. Intensive outpatient prolonged exposure for combat-related PTSD: A case study. Cognitive and Behavioral Practice. 2014; 21, 89-96. doi:10.1016/j.cbpra.2013.05.004
Cigrang JA, Rauch SA, Mintz J, Brundige A, Avila LL, Bryan CJ, Goodie JL, Peterson AL; STRONG STAR Consortium. Treatment of active duty military with PTSD in primary care: A follow-up report. J Anxiety Disord. 2015 Dec;36:110-4. doi: 10.1016/j.janxdis.2015.10.003. Epub 2015 Oct 22. — View Citation
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. — View Citation
Foa EB, Hembree EA, Rothbaum, BO. Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences therapist guide. New York, NY: Oxford University Press. 2007.
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. Erratum in: JAMA. 2018 Aug 21;320(7):724. — View Citation
Peterson AL, Foa EB, Riggs DS. Prolonged exposure therapy for combat-related PTSD. In B. A. Moore, & W. Penk (Eds.), Treating PTSD in military personnel: A clinical handbook (pp. 42-58). New York, NY: Guilford. 2011.
Peterson AL, Luethcke CA, Borah EV, Borah AM, Young-McCaughan S. Assessment and treatment of combat-related PTSD in returning war veterans. J Clin Psychol Med Settings. 2011 Jun;18(2):164-75. doi: 10.1007/s10880-011-9238-3. — View Citation
Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2. — View Citation
Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. — View Citation
Resick PA, Wachen JS, Mintz J, Young-McCaughan S, Roache JD, Borah AM, Borah EV, Dondanville KA, Hembree EA, Litz BT, Peterson AL. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J Consult Clin Psychol. 2015 Dec;83(6):1058-1068. doi: 10.1037/ccp0000016. Epub 2015 May 4. — View Citation
Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370. Review. — View Citation
Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11. — View Citation
Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr, PP. The PTSD Checklist for DSM-5 (PCL-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 2013.
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 to 4 Weeks (Posttreatment) |
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