TY - JOUR
AU - J. C. Fortney
AU - D. L. Kaysen
AU - C. C. Engel
AU - J. M. Cerimele
AU - J. P. Nolan Jr.
AU - E. Chase
AU - B. E. Blanchard
AU - S. Hauge
AU - J. Bechtel
AU - A. Taylor
AU - R. Acierno
AU - N. Nagel
AU - R. K. Sripada
AU - J. T. Painter
AU - B. B. DeBeer
AU - A. Zimberoff
AU - E. J. Bluett
AU - A. R. Teo
AU - L. A. Morland
AU - K. Grubbs
AU - D. M. Sloan
AU - B. P. Marx
AU - P. J. Heagerty
A1 - 
AB - IMPORTANCE: There have only been 3 efficacy trials reporting head-to-head comparisons of pharmacotherapy and trauma-focused psychotherapy for posttraumatic stress disorder (PTSD), and none were conducted in primary care. In addition, few trials have examined treatment sequences for patients not responding to an initial treatment. OBJECTIVE: To test the hypothesis that (1) brief trauma-focused psychotherapy (written exposure therapy [WET]) is more effective than a choice of 3 selective serotonin reuptake inhibitors (SSRIs; ie, sertraline, fluoxetine, or paroxetine) and (2) WET augmentation is more effective than switching to the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine for those not responding to an SSRI. DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic comparative effectiveness trial conducted from April 2021 to June 2024 that randomized primary care patients to 1 of 3 treatment sequences: (1) SSRI followed by WET augmentation, (2) SSRI followed by switch to SNRI, or (3) WET followed by SSRI. Effectiveness in this pragmatic trial depends on treatment engagement and treatment fidelity. The study included patients meeting clinical criteria for PTSD from primary care clinics of 7 federally qualified health centers and 8 Department of Veterans Affairs medical centers. INTERVENTIONS: SSRI followed by WET augmentation, SSRI followed by switch to SNRI, or WET followed by SSRI. MAIN OUTCOMES AND MEASURES: PTSD symptom severity, as measured by the DSM-5 PTSD Checklist (PCL-5). RESULTS: A total of 700 patients (mean [SD] age, 45.1 [15.4] years; 368 men [62.1%]). The mean (SD) baseline PCL-5 score was 52.8 (11.1), indicating considerable symptom severity. At 4 months, 144 of 278 patients (51.8%) randomized to an SSRI were adherent and reported a 14.0-point PCL-5 decrease, whereas 111 of 352 patients (31.5%) randomized to WET completed all sessions and reported a 12.1-point decrease. There was no significant between-group difference (adjusted mean difference [MD], 1.79; 95% CI, -0.76 to 4.34; P = .17). For the 122 of 295 patients (41.4%) randomized to an SSRI who did not respond to treatment, those randomized to switch to the SNRI reported a 9.2-point PCL-5 decrease compared with a 2.3-point decrease for those randomized to WET augmentation, which was a statistically significant between-group difference (adjusted MD, 10.19; 95% CI, 4.97-15.41; P < .001). CONCLUSIONS AND RELEVANCE: Study results showed that treatment of PTSD in primary care with either SSRIs or WET was feasible and effective. For patients not responding to an SSRI, switching to an SNRI may be more effective than WET augmentation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04597190.
AD - Department of Psychiatry and Behavioral Sciences, Division of Population Health, School of Medicine, University of Washington, Seattle.; VA Health Systems Research, Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound, Seattle, Washington.; Department of Psychiatry and Behavioral Sciences, Division of Public Mental Health & Population Sciences, School of Medicine, Stanford University, Palo Alto, California.; Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio.; El Dorado, Arkansas.; Primary Care Behavioral Health, VA Bedford Healthcare System, Bedford, Massachusetts.; Ralph H Johnson VA Healthcare System, Charleston, South Carolina.; Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center, Houston.; Primary Care Mental Health Integration, Cincinnati VA Medical Center, Cincinnati, Ohio.; Department of Psychiatry, University of Michigan, Ann Arbor.; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.; Health Systems Research Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System, North Little Rock.; Division of Pharmaceutical Evaluation & Policy, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock.; Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Denver.; VA Rocky Mountain Mental Illness, Research, Education, and Clinical Center for Suicide Prevention, Denver, Colorado.; HealthPoint SeaTac, SeaTac, Washington.; Family Medicine Residency, University of Montana, Missoula.; Department of Psychiatry, Oregon Health & Science University, Portland.; Health Systems Research, Center to Improve Veteran Involvement in Care, VA Portland Health Care System, Portland, Oregon.; Department of Psychiatry, University of San Diego, San Diego, California.; VA San Diego Healthcare System, San Diego, California.; National Center for PTSD at VA Boston Healthcare System, Boston, Massachusetts.; Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts.; Department of Biostatistics, School of Public Health, University of Washington, Seattle.
AN - 41091477
BT - JAMA Psychiatry
C5 - Healthcare Disparities
CP - 12
DA - Dec 1
DO - 10.1001/jamapsychiatry.2025.2962
DP - NLM
IS - 12
JF - JAMA Psychiatry
LA - eng
N2 - IMPORTANCE: There have only been 3 efficacy trials reporting head-to-head comparisons of pharmacotherapy and trauma-focused psychotherapy for posttraumatic stress disorder (PTSD), and none were conducted in primary care. In addition, few trials have examined treatment sequences for patients not responding to an initial treatment. OBJECTIVE: To test the hypothesis that (1) brief trauma-focused psychotherapy (written exposure therapy [WET]) is more effective than a choice of 3 selective serotonin reuptake inhibitors (SSRIs; ie, sertraline, fluoxetine, or paroxetine) and (2) WET augmentation is more effective than switching to the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine for those not responding to an SSRI. DESIGN, SETTING, AND PARTICIPANTS: This was a pragmatic comparative effectiveness trial conducted from April 2021 to June 2024 that randomized primary care patients to 1 of 3 treatment sequences: (1) SSRI followed by WET augmentation, (2) SSRI followed by switch to SNRI, or (3) WET followed by SSRI. Effectiveness in this pragmatic trial depends on treatment engagement and treatment fidelity. The study included patients meeting clinical criteria for PTSD from primary care clinics of 7 federally qualified health centers and 8 Department of Veterans Affairs medical centers. INTERVENTIONS: SSRI followed by WET augmentation, SSRI followed by switch to SNRI, or WET followed by SSRI. MAIN OUTCOMES AND MEASURES: PTSD symptom severity, as measured by the DSM-5 PTSD Checklist (PCL-5). RESULTS: A total of 700 patients (mean [SD] age, 45.1 [15.4] years; 368 men [62.1%]). The mean (SD) baseline PCL-5 score was 52.8 (11.1), indicating considerable symptom severity. At 4 months, 144 of 278 patients (51.8%) randomized to an SSRI were adherent and reported a 14.0-point PCL-5 decrease, whereas 111 of 352 patients (31.5%) randomized to WET completed all sessions and reported a 12.1-point decrease. There was no significant between-group difference (adjusted mean difference [MD], 1.79; 95% CI, -0.76 to 4.34; P = .17). For the 122 of 295 patients (41.4%) randomized to an SSRI who did not respond to treatment, those randomized to switch to the SNRI reported a 9.2-point PCL-5 decrease compared with a 2.3-point decrease for those randomized to WET augmentation, which was a statistically significant between-group difference (adjusted MD, 10.19; 95% CI, 4.97-15.41; P < .001). CONCLUSIONS AND RELEVANCE: Study results showed that treatment of PTSD in primary care with either SSRIs or WET was feasible and effective. For patients not responding to an SSRI, switching to an SNRI may be more effective than WET augmentation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04597190.
PY - 2025
SN - 2168-622X (Print); 2168-622x
SP - 1203
EP - 1215+
ST - Pragmatic Comparative Effectiveness of Primary Care Treatments for Posttraumatic Stress Disorder: A Randomized Clinical Trial
T1 - Pragmatic Comparative Effectiveness of Primary Care Treatments for Posttraumatic Stress Disorder: A Randomized Clinical Trial
T2 - JAMA Psychiatry
TI - Pragmatic Comparative Effectiveness of Primary Care Treatments for Posttraumatic Stress Disorder: A Randomized Clinical Trial
U1 - Healthcare Disparities
U3 - 10.1001/jamapsychiatry.2025.2962
VL - 82
VO - 2168-622X (Print); 2168-622x
Y1 - 2025
ER -