Study Results
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Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2022-01-03
2027-01-29
Brief Summary
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Detailed Description
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OEF/OIF Veterans have experienced increased length and number of deployments, contributing to diagnosis of PTSD. rTMS is a brain-based therapy involving application of a repetitive, brief magnetic pulse to the scalp through an electromagnetic coil. rTMS applied to the dorsolateral prefrontal cortex (DLPFC) has efficacy in patients with treatment-resistant depression, and recent work has shown efficacy for treating PTSD. Standard rTMS treatments are stand-alone, though the unique properties of rTMS may make it more effective when added to a psychotherapy such as an evidence-based psychotherapy (EBP) for PTSD.
rTMS is theorized to act on the DLPFC node of the brain's cognitive control network (CCN) to improve emotion regulatory processes and facilitate reduction in affective symptoms. In support of this theory, studies have found that improvements in affective flexibility, upregulation of positive affect, and downregulation of attention to negative stimuli occur in task-based paradigms immediately following stimulation of the DLPFC with rTMS in a single-session. In addition, recent research has found that rTMS prior to cognitive processing therapy (CPT) in Veterans with PTSD is effective at improving PTSD outcomes compared to sham rTMS plus CPT, possibly through the regulatory mechanism of the CCN. Given these promising findings, further study into optimizing rTMS-augmented EBPs for PTSD is warranted.
There are limitations to both rTMS and first line EBPs for PTSD. One problem is high numbers of sessions needed for effective treatment (i.e. 20 sessions of rTMS and 12-18 sessions of EBPs) contributing to high attrition rates. A large multi-site study of VA patients in PTSD clinic found that just 2% of a sample of 1924 Veterans who had at least one session of EBP received an "adequate dose" of at least 8 sessions.12 A potential optimization for rTMS-augmented EBPs would be to reduce session number to improve retention. WET is a novel EBP for PTSD that is non-inferior to CPT in as few as 5 sessions. Using rTMS to augment WET in Veterans with PTSD is a crucial step in this line of inquiry.
This double-blind, Phase II randomized controlled trial will examine whether rTMS added to WET results in superior outcomes compared to sham rTMS added to WET (N=98 with women and men equally represented). The investigators will randomize 49 OEF/OIF Veterans with PTSD to undergo an active rTMS/WET treatment protocol versus 49 OEF/OIF Veterans given a sham rTMS/WET treatment.
Specific Aim 1: To compare PTSD outcomes of those who experience active rTMS/WET versus sham rTMS/WET. Hypothesis 1: Active rTMS added to WET will contribute to greater PTSD symptom reduction compared to sham rTMS added to WET in Veterans with PTSD.
Specific Aim 2a: If there is a treatment effect in Aim 1, determine if emotional flexibility mediates the rTMS/WET-PTSD relation. Aim 2b (exploratory): Determine if emotional flexibility has a unique mediating effect over cognitive flexibility. Hypothesis 2a: Significant reduction in PTSD symptoms will be partially mediated by emotional flexibility. Hypothesis 2b: Significant reduction in PTSD symptoms will be partially mediated by cognitive flexibility, but to a lesser extent than emotional flexibility.
This CDA-2 extends Dr. Lantrip's research integrating emotion regulation and neurostimulation to understand and improve upon treatment of PTSD in Veterans. The CDA-2 will provide her with specialized training in WET, a unique exposure-based therapy for the treatment of trauma, as well as clinical trials for PTSD, and neurostimulation. The mentoring team integrates expertise in the proposed areas of study and extensive experience mentoring early career investigators. Project findings will inform a future VA Merit proposal, which will focus on individual differences and mechanisms contributing to PTSD symptom improvement in TMS-augmented behavioral therapy. This study has the potential to inform and improve upon existing treatments for PTSD. Together, Dr. Lantrip's work aligns with VA's priorities, CR\&D's mission, and with the goal to provide the highest quality of care for Veterans.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active TMS/WET
Active repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Written Exposure Therapy
Narrative written disclosure of trauma administered in an evidence-based protocol.
repetitive transcranial magnetic stimulation
Noninvasive magnetic neuromodulation device
Sham TMS/WET
Sham repetitive transcranial magnetic stimulation completed prior to written exposure therapy
Written Exposure Therapy
Narrative written disclosure of trauma administered in an evidence-based protocol.
repetitive transcranial magnetic stimulation
Noninvasive magnetic neuromodulation device
Interventions
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Written Exposure Therapy
Narrative written disclosure of trauma administered in an evidence-based protocol.
repetitive transcranial magnetic stimulation
Noninvasive magnetic neuromodulation device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* veteran;
* English-speaking and able to provide written informed consent;
* diagnosed with PTSD;
* between the ages of 18 and 60 years. Participants over age 60 will not be included, as aging is known to impact brain structure, and thus the potential accuracy of the rTMS target, independently of PTSD.
Exclusion Criteria
* The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
* Participants will also be screened and excluded if any of the following are met:
* current psychosis including psychotic disorder,
* bipolar disorder,
* schizophrenia; or another severe cognitive or psychiatric disorder;
* positive screen for current suicidal intent and plan \[with a score of 2 or 3 on BDI-2 item 9\];
* current substance use disorder; or substance use in the last 12 hours before the rTMS session.
* The investigators note that PTSD is often comorbid with traumatic brain injury (TBI) in military veterans who were deployed to a war zone. The investigators will use the Department of Defense and Veterans Affairs consensus-based classification of TBI severity for classification of TBI.
* Participants with moderate or severe TBI will be excluded.
* Participants with mild traumatic brain injury (mTBI) or concussion will be enrolled. This will enhance the ecological validity of the study.
* Participants with cognitive impairment as evidenced by a Montreal Cognitive Screen (MoCA) less than 23/30 or estimated baseline intellectual ability of a standard score of less than 80 on a word reading test will be excluded due to potential neurocognitive differences.
* Participants on psychotropic medications will not be excluded, but participants will be required to be stable on their medication for at least four weeks prior to beginning the study and throughout the time of study.
* Participants enrolled in long term, supportive psychotherapy (i.e. not an evidence-based psychotherapy (EBP)) may continue to be involved in their treatment throughout the study. However, participants involved in a concurrent EBPs will be excluded. Participants will be asked to disclose whether they chose to participate in an EBP during the course of the treatment or followup phases of the study.
18 Years
60 Years
ALL
No
Sponsors
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National Center for PTSD
FED
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Crystal M Lantrip
Role: PRINCIPAL_INVESTIGATOR
Central Texas Veterans Health Care System, Temple, TX
Locations
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Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MHBP-007-20F
Identifier Type: -
Identifier Source: org_study_id
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