Our Research Breakthroughs & Stories
Veterans Medical Research Foundation announces two new clinical trial awards from the Congressional Directed Medical Research Program, awarded to Dr. Sonya Norman
Monday, February 12, 2024
SONYA NORMAN, PhD Dr. Norman directs the U.S. National Center for PTSD’s PTSD Consultation Program, is a researcher in the VA’s Center of Excellence for Stress and Mental Health, and Professor of Psychiatry at the University of California San Diego School of Medicine.
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DOD Grant Number: HT9425-23-1-0861
Project Period: 09/01/2023-05/31/2027
Title: Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy
Compared to Prolonged Exposure (TriGR)
Contracting/Performing Organizations: Veterans Medical Research Foundation of San Diego
San Diego Veterans Administration Healthcare System
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OVERVIEW
This project proposes to establish whether trauma-informed guilt reduction therapy (TrIGR) is effective for a large group of veterans (anyone who served post 9/11 with guilt from any kind of trauma) and whether it is as effective as longer treatments already available within sessions of TrIGR are noninferior to 12 sessions of prolonged exposure (PE) in reducing posttraumatic stress disorder (PTSD) symptom severity among veterans with PTSD who endorse trauma-related guilt symptoms and superiority in reducing trauma-related guilt and shame, explore treatment differences in change in suicidal ideation and dropout, explore mechanisms of change, and explore if guilt and shame mediate the relationship between treatment condition and PTSD, functioning, and depression outcomes. A hybrid type I randomized treatment clinical trial will be performed. The intervention is administration of TrIGR over 6 weekly sessions and administration of PE over 12 weekly sessions with assessments of primary and secondary outcomes at baseline, 8, 16, and 28 weeks after the first therapy session. The projected results are an understanding of the effectiveness of TrIGR.
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DOD Grant Number: HT94252310669
Project Period: 09/01/2023-05/31/2027
Title: Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among
Veterans in Intensive Outpatient Substance Use Treatment (MPE/PTSD)
Contracting/Performing Organizations: Veterans Medical Research Foundation of San Diego
San Diego Veterans Administration Healthcare System
OVERVIEW
This project proposes to evaluate the effectiveness of massed prolonged exposure therapy (M-PE) delivery in substance use disorder (SUD) intensive outpatient programming (IOP) in reducing dropout rates and improving outcomes as compared to weekly PE (WPE) delivery. The specific aims are to (1) compare the effectiveness of M-PE to W-PE concurrent to IOP SUD treatment in impacting posttraumatic stress disorder (PTSD) symptoms and PE completion; (2) compare differences in treatment arms on patient-centered outcomes, including percent days with drug use or heavy drinking, functioning, depressive symptoms, suicidal-related thoughts, and participant satisfaction; (3) conduct a mixed-method process evaluation to understand patients, providers, and clinical -PE, explore barriers and facilitators to integrating M-PE into IOP SUD treatments within Veterans Affairs (VA) and DOD, and identify strategies for widespread implementation. The application outlines a mixed-method 2-group hybrid type I effectiveness/implementation randomized clinical trial. The intervention is that M-PE (delivered 4 days per week over up to 3 weeks) will be compared to PE delivered as usual (i.e., weekly; W-PE) initiated concurrent to IOP SUD treatment programs in 4 VA clinics. The projected results are to learn about barriers and facilitators to implementing M-PE in IOP SUD settings and enable identification of potential implementation strategies for spread in VA and DOD communities as warranted effective PTSD treatments.
PI: Samir Gupta, MD
Agency: Patient Centered Outcomes Research Institute (PCORI)
Title: Colonoscopy versus stool-based testing for older adults with a history of colon polyps (COOP)
Period: 04/01/2024-03/31/2026
Overview:
In a survey of older adults, half preferred FIT, a non-invasive, low cost, stool-based test, to colonoscopy for surveillance of polyps. This approach has not been studied, leading to its absence from major society guidelines. The COOP Trial addresses this evidence gap, as a comparative effectiveness randomized controlled trial (RCT) comparing colonoscopy versus annual FIT for post-polyectomy surveillance among adults aged 65-82 with a history of low-risk colorectal polyps who are due for surveillance colonoscopy within the coming year.
PI: Leslie Morland, PhD
DOD Grant Number: HT94252410499
Title: A Hybrid-1 Effectiveness Implentation Trial of Partner-Assisted Prolonged Exposure for PTSD
Period: 09/30/2024-09/29/2028
Overview:
Partnering with significant others may prove a powerful method for helping Veterans get the most out of their PTSD treatment. The aim of this study is to determine if Partner Assisted Prolonged Exposure (PPE) differs from standard Prolonged Exposure (PE) in its effects on outcomes for intimate partners, including romantic functioning, psychological distress, caregiver burden, and psychosocial functioning.
PI: Victoria Merritt, PhD
DOD Grant Number: HT9425-25-1-0027
Title: Polygenic Risk Scores (PRS) to Predict Post-Traumatic Epilepsy (PTE) in the Million Veteran Program (MVP) Cohort
Period: 07/01/2025-06/30/2028
Overview:
Post-Traumatic Epilepsy (PTE) is a common complication of traumatic brain injury (TBI), but not all people who survive a TBI develop epilepsy. Thus, if we can predict who is at highest risk for developing PTE, we can design interventions to optimize functional outcomes after TBI and prevent PTE. This study involves phenotyping Veterans with PTE, developing a polygenic risk score (PRS) to predict risk of PTE, and identifying genetic biomarkers of PTE risk.
New hope for Veterans with traumatic brain injury
The use of transcranial magnetic stimulation (TMS) for headaches related to mTBI involves four 5-minute treatment sessions within the first week, with single sessions, repeated every four to eight weeks as needed.
Friday, December 15, 2017
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Dr. Albert Leung and his team at VA San Diego Healthcare System (VASDHS) Center for Pain and Headache Research have pioneered a treatment for headache pain associated with mTBI. Using transcranial magnetic stimulation, or TMS, clinicians take an electromagnetic coil – charge it with electricity, and apply it to specific points on the skull. Using brain magnetic resonance imaging (MRI) based neuronavigation guidance, Dr. Leung’s team can accurately and consistently deliver a targeted magnetic field to specific brain areas. TMS is FDA approved for major depression and certain types of migraines that don’t respond to other treatments; and, up until now has had limited research on the potential of TMS for treating other types of headaches. More
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