Integrating biological treatment mechanisms into randomized clinical trials: Design of PROGrESS (PROlonGed ExpoSure and Sertraline Trial)

被引：26

作者：

Rauch, Sheila A. M. ^{[1
,2
]}

Simon, Naomi M. ^{[3
,4
]}

Kim, H. Myra ^{[5
,6
]}

Acierno, Ron ^{[8
,9
]}

King, Anthony P. ^{[5
,7
]}

Norman, Sonya B. ^{[12
,13
,14
]}

Venners, Margaret R. ^{[5
]}

Porter, Katherine ^{[5
,7
]}

Phan, K. Luan ^{[16
,17
]}

Tuerk, Peter W. ^{[8
,10
]}

Allard, Carolyn ^{[11
,14
,15
]}

Liberzon, Israel ^{[5
,7
]}

Rothbaum, Barbara O. ^{[2
]}

Martis, Brian ^{[5
,7
]}

Stein, Murray B. ^{[11
,14
]}

Hoge, Charles W. ^{[18
]}

机构：

[1] Atlanta VA Med Ctr, 1670 Clairmont Rd, Atlanta, GA 30033 USA

[2] Emory Univ, Sch Med, 12 Execut Pk,3rd Floor, Atlanta, GA 30029 USA

[3] Massachusetts Gen Hosp, Dept Psychiat, One Bowdoin Sq,6th Floor, Boston, MA 02114 USA

[4] NYU, Med Sch, Dept Psychiat, One Pk Ave,8th Floor, New York, NY 10016 USA

[5] VA Ann Arbor Healthcare Syst, 2215 Fuller Rd, Ann Arbor, MI 48105 USA

[6] Univ Michigan, Consulting Stat Comp & Analyt Res, 3550 Rackham,950 E Washington St, Ann Arbor, MI 48109 USA

[7] Univ Michigan, Dept Psychiat, 4250 Plymouth Rd, Ann Arbor, MI 48109 USA

[8] Ralph H Johnson VA Med Ctr, 109 Bee St, Charleston, SC 29401 USA

[9] Med Univ South Carolina, Coll Nursing, Jonathan Lucas St, Charleston, SC 29425 USA

[10] Med Univ South Carolina, Dept Psychiat, 67 President St, Charleston, SC 29425 USA

[11] VA San Diego Healthcare Syst, 3350 Villa La Jolla Dr, San Diego, CA 92161 USA

[12] Natl Ctr PTSD, 215 N Main St, White River Jct, VT 05009 USA

[13] VA Ctr Excellence Stress & Mental Hlth, 3350 La Jolla Village Dr,MC116B, San Diego, CA 92161 USA

[14] Univ Calif San Diego, Sch Med, 9500 Gilman Dr, La Jolla, CA 92037 USA

[15] Solara Mental Hlth San Diego, San Diego, CA USA

[16] Univ Illinois, Dept Psychiat, 1747 W Roosevelt Rd, Chicago, IL 60608 USA

[17] Jesse Brown VA Med Ctr, 820 S Damen Ave, Chicago, IL 60612 USA

[18] Walter Reed Army Inst Res, 503 Robert Grant Ave, Silver Spring, MD 20910 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2018年 / 64卷

基金：

美国国家卫生研究院;

关键词：

Randomized controlled trial; Posttraumatic stress disorder; Biomarkers; Mechanisms; Methods; POSTTRAUMATIC-STRESS-DISORDER; COGNITIVE-BEHAVIORAL THERAPY; ANTERIOR CINGULATE CORTEX; TRAUMATIC BRAIN-INJURY; MENTAL-HEALTH PROBLEMS; PSYCHOMETRIC PROPERTIES; ANXIETY DISORDERS; NEURAL PREDICTORS; EMOTIONAL STIMULI; AMYGDALA;

D O I：

10.1016/j.cct.2017.10.013

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Increased emphasis on mechanisms of treatment effectiveness, biomarker predictors, and objective indicators of treatment response has sparked interest in integrated, translational treatment outcomes trials. The PROlonGed ExpoSure and Sertraline Trial (PROGrESS) is one such randomized controlled trial (RCT) focused on a key question in clinical management of posttraumatic stress disorder (PTSD) - the comparative and combined effectiveness of medication and psychotherapy. PROGrESS employs a state of the art trial design to examine psychotherapy and medication effects across three conditions: 1) Prolonged Exposure (PE) plus pill placebo, 2) Sertraline (SERT) plus Enhanced Medication Management (EMM), and 3) Combined treatment (PE/SERT). Innovative measures will capture potential biomarker predictors and indicators of treatment response within and across these three treatment conditions in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) service members and veterans with PTSD. Assessments include clinician-rated measures, self-report outcome measures, saliva for salivary cortisol and cortisol response to awakening at six assessment points, blood at baseline and week 24 for genetic and genomic analysis, as well as resting state connectivity and emotion processing and regulation using functional Magnetic Resonance Imaging (fMRI) paradigms in a subsample of veterans. Accordingly, the current study is designed to provide pragmatic clinical direction for the delivery of PTSD treatment through its primary outcomes in an effectiveness design, and will also provide informative results to elucidate underlying mechanisms and biomarkers involved in PTSD treatment response.

引用

页码：128 / 138

页数：11

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