Safety, Feasibility, and Benefits of Transcranial Direct Current Stimulation (tDCS) in Human Subjects With Posttraumatic Stress Disorder (PTSD) Receiving an Exposure-based, Behavioral Therapy
Phase: NA
Conditions: Post Traumatic Stress Disorder
Sponsor: The University of Texas Health Science Center at San Antonio

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Title: Safety, feasibility, and benefits of transcranial direct current stimulation (tDCS) in human subjects with PTSD 
receiving an exposure-based, behavioral therapy
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1. PROTOCOL TITLE: Safety, feasibility, and benefits of transcranial direct current stimulation (tDCS) in human subjects with 
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PTSD receiving an exposure-based, behavioral therapy
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2. ABSTRACT. 
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Symptoms of posttraumatic stress disorder (PTSD) include intrusive memories about the event, physiological hyperarousal, 
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sleep difficulties, and negative alterations to mood and cognitions, all of which can have significant, long-term effects on 
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health and functioning. Evidence-based non-pharmacological, psychotherapies for PTSD exist and are well-established 
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(Lewis et al., 2020). However, there remains room for improvement in outcomes given that a proportion of patients (~50%) do 
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not significantly benefit from treatment (Steenkamp et al., 2015a). The field of non-invasive brain stimulation is rapidly gaining 
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considerable attention as a potential therapeutic for PTSD based on the ability to modulate brain activity in regions associated 
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with the fear response and extinction learning (two critical constructs associated with PTSD pathology and PTSD treatment). 
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While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and 
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benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, we will conduct a partially double -
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blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 
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adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral 
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psychotherapy for PTSD.
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3. OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS.
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The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment 
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benefits of tDCS, a noninvasive brain stimulation technique, when delivered in combination with WET for PTSD.
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Specific Aims and Hypotheses:
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Aim 1: To evaluate the safety of tDCS vs. sham when combined with WET. 
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Hypothesis 1: tDCS can be safely combined with WET for PTSD as indicated by minimal adverse events (AEs) and 
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high tolerability of any observed study related AEs.
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Aim 2: To evaluate the feasibility of combining tDCS with WET for PTSD as measured by rates of enrollment, recruitment, 
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and treatment completion.
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Aim 3: To explore PTSD symptom reductions associated with tDCS vs. sham when combined with WET.
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Hypothesis 2: tDCS can reduce PTSD severity more so than a sham condition when combined with WET for PTSD 
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on the PTSD Checklist (PCL-5).
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Hypothesis 3: tDCS can decrease physiological arousal (heart rate and galvanic skin response) associated with the 
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stress response during written exposure.
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4. MILITARY RELEVANCE. 
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The proposed study will recruit civilians and military veterans seeking PTSD treatment. Although this study will recruit a 
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mixed sample of civilians and veterans, findings from this study can inform existing literature focused on military-related 
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PTSD. Compared to civilians, the rate of PTSD is particularly elevated among military populations, with approximately 
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23% of military vs. 6-8% of civilians meeting criteria for PTSD (Fulton et al., 2015). Furthermore, PTSD has been 
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identified as the signature deployment-related psychiatric condition among service members. The functional impact of 
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PTSD can cost service members their military careers and veterans with PTSD are at increased risk of unemployment 
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and homelessness following military separation (Asnaani et al., 2014). Notwithstanding evidence that current first-line 
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treatments are effective for PTSD, there remains room for improvement in outcomes given that a large proportion of 
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patients (~50%) do not significantly benefit from treatment (Steenkamp et al., 2015b). Research dedicated to evaluating 
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novel treatments for PTSD has the potential to promote greater PTSD treatment efficacy that will lead to greater symptom 
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reductions, positive well-being, and improved functioning in the military community.
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5. BACKGROUND AND SIGNIFICANCE.
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Impact and Prevalence of PTSD: Approximately, 70% of the U.S. population (~232 million) will experience a traumatic 
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event in their lifetime and 7% of those individuals (~16 million) will go on to develop PTSD (Benjet et al., 2016). Symptoms 
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of PTSD can include fear, anxiety, negative mood, uncontrollable/negative thoughts about the event, sleep disturbances, 
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and avoidance of environmental trauma reminders. The impact of PTSD is substantial and often results in chronic, 
HUMAN SUBJECTS RESEARCH PROTOCOL

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pervasive functional problems with relationships, work, and physical health (Asnaani et al., 2014). When left untreated, it 
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can lead to detriments in mental health and psychosocial functioning (Pacella et al., 2013; Thomas et al., 2010). The 
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overall impact of PTSD is substantial and often leads to significant burdens on the individual, their family, and the 
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community (Renshaw et al., 2011). The sequalae of PTSD not only impacts an individual’s immediate environment but 
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also places significant burden on society due to increased work sick days and greater healthcare utilization (Asnaani et 
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al., 2014; Thomas et al., 2010).
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Non-Pharmacological, Psychotherapy Approaches to PTSD Treatment: Evidence-based non-pharmacological, 
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psychotherapies for PTSD exist and are well-established (Lewis et al., 2020). Written Exposure Therapy (WET) is a type 
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of first-line, exposure-based psychotherapy for PTSD that is recommended in the International Society for Traumatic 
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Stress Studies (ISTSS) and Veterans Administration and Department of Defense (VA/DoD) Clinical Practice Guidelines 
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(Forbes et al., 2020; VA/DoD, 2018). WET aims to reduce trauma-related distress and PTSD symptoms through an 
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exposure-based intervention that promotes extinction learning and emotional processing by writing about the traumatic 
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event (Sloan et al., 2018, 2020; Sloan & Marx, 2019). Extinction learning can be defined within the context of operant and 
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classical conditioning theory, where there is a gradual decrease in response that occurs when a stimulus is presented 
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without reinforcement. Exposure to a traumatic event and PTSD can result in the development of a maladaptive fear 
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response. That is, an individual’s response to “innocuous,” conditioned stimuli (e.g., “a crowded restaurant”) can be 
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repeatedly interpreted as “dangerous” (i.e., conditioned response) based on the prior exposure to a traumatic event (e.g., 
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“bomb exploded in a crowded area while deployed to a combat zone”). This interpretation often prompts negative 
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reinforcement behaviors (i.e., avoidance or safety strategies to reduce anxiety) that prevent extinction learning processes 
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to the feared conditioned stimuli  (Foa et al., 1991). During WET, individuals are encouraged to approach the trauma 
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memory through writing about the event so that they can make sense of the trauma, develop healthy coping strategies, 
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and mitigate avoidance behaviors. WET is comprised of five treatment sessions and is a brief, scalable first-line 
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psychotherapy for PTSD. During each WET session, patients write about their traumatic event using empirically 
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supported, therapist-guided writing instructions for approximately 30 minutes. In the first session, the therapist guides the 
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participant through the writing. In subsequent sessions, participants complete writing independently. Individuals are 
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prompted to write about the details of the traumatic event during initial writing sessions and then about the impact of the 
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trauma in later sessions. Following the half hour of writing, the therapist briefly meets with the participant for 15-30 
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minutes to talk about their writing. At the end of the appointment, individuals are encouraged to allow themselves to think 
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about the trauma between session, but no formal between session homework assignments are assigned. Overall, 
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research has shown that WET is non-inferior to CPT, a first-line psychotherapy for PTSD and requires less than half of the 
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sessions (Sloan et al., 2018). Notwithstanding evidence that WET and other first-line psychotherapies are effective 
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treatments for PTSD, there remains room for improvement in outcomes given that a large proportion of patients (~50%) 
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do not significantly benefit from treatment (Steenkamp et al., 2015). Overall, the therapeutic needs of individuals with 
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PTSD are significant and combined interventions that adapt currently available treatments have the potential to improve 
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outcomes for many individuals suffering from PTSD.
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PTSD and the Brain: As noted above, the constellation of PTSD symptoms is largely characterized by a maladaptive fear 
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response. First-line psychotherapies for PTSD aim to target and modify the individual’s fear response through extinction 
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learning interventions. Therefore, the success of exposure-based psychotherapy is dependent on the efficacy of extinction 
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learning. Within the brain, the fear response and conditioned learning are associated with the prefrontal cortex (PFC), 
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which modulates fear signaling (i.e., extinction learning) between the amygdala and dorsal anterior cingulate. Research 
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has shown that PFC signal modulation to other critical brain areas is associated with extinction learning. These pathways 
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are often inhibited for individuals with PTSD (Etkin & Wager, 2007). Therefore, interventions that can augment activity in 
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brain areas related to extinction learning, particularly during an exposure-based task, are of high relevance for PTSD 
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treatments.
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Transcranial Direct Current Stimulation (tDCS): One promising method to activate brain regions critical to extinction 
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learning is non-invasive brain stimulation, which permits targeted intervention of the aforementioned brain regions 
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associated with PTSD. Non-invasive brain stimulation was first performed over 80 years ago when Ugo Cerletti and his 
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collaborators used electricity to induce seizures in a patient with paranoid psychosis. Electroconvulsive therapy (ECT) 
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continues to be in use today; however, while effective, the risk of adverse cognitive effects limits the use of ECT to severe, 
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treatment-resistant patients. More recently, there have been advances in non-invasive brain stimulation techniques that 
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are safer and do not result in the negative side effects associated with ECT. Specifically, the use of repetitive transcranial 
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magnetic stimulation (rTMS) and tDCS have provided a significant advance whereby pathophysiological alterations in the 
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brain can be safety targeted without significant negative side effects (Clark et al., 2015; Marin et al., 2014; van ’t Wout-

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Frank et al., 2019; van ’t Wout et al., 2017).. tDCS is of particular interest because of its cost-effectiveness, device 
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portability, and robust safety/side effect profile (Bikson et al., 2016). tDCS involves the use of a low grade (subthreshold), 
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consistent electrical current (1-2 mA) that is typically delivered through two electrodes placed on the scalp for 
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approximately 30 minutes (Nitsche et al., 2008). During stimulation, a current flows between the electrodes passing 
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through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing 
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neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize (Rahman et al., 2017). Anodal 
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tDCS increases the excitability of the cortex whereas cathodal tDCS decreases it.
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Safety and Effect of tDCS: There has been a great deal of research on the safety of tDCS, which suggests that the 
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technique is safe, does not cause permanent or severe damage, or discomfort when used according to appropriate 
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guidelines (Thair et al., 2017). To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA) has not 
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produced any reports of Serious AEs or irreversible injury across over 33,000 sessions and 1,000 subjects with repeated 
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sessions (e.g., Bikson et al., 2016). These results comprise 
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a diverse pool of subjects that includes individuals from 
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potentially vulnerable populations (e.g., those with a 
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psychiatric diagnosis, in pain, and those with neurological 
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conditions). Overall, tDCS has received a “nonsignificant 
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risk” determination from different IRBs monitoring a number 
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of trials (Fregni et al., 2015). Typical side effects are minor 
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and transient (e.g., skin irritation, tingling, and minor 
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headaches), with such AEs mitigated by appropriate 
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screening (e.g., exclusion for history of skin condition) and 
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the use recommended tDCS guidelines (Bikson et al., 2016; 
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DaSilva et al., 2011; Thair et al., 2017).
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Existing research on the effects of tDCS for a variety of 
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psychiatric conditions is promising but remains in the early 
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stages of exploration (see Kekic et al., 2016). Depression is 
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the most extensively researched use of tDCS to treat 
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psychiatric conditions to date, but preliminary studies have 
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also evaluated conditions, such as schizophrenia, 
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substance use, and anxiety-related disorders. With regard 
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to PTSD, preliminary, proof-of-concept laboratory models in 
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humans have demonstrated that non-invasive brain 
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stimulation via tDCS can stimulate the PFC and reduce 
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maladaptive fear responses during an extinction learning 
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task, with minimal AEs that are highly tolerable (Raij et al., 
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2018;van ’t Wout et al., 2016; van ’t Wout et al., 2017). In a 
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pilot study of tDCS vs. sham combined with a virtual reality 
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exposure protocol, a sample of military veterans 
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demonstrated a reduction in physiological and self-reported 
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PTSD symptoms, with minimal AEs (van ’t Wout-Frank et 
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al., 2019). Current tDCS approaches for PTSD appears 
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promising, but more research is needed. As detailed above, 
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the PFC plays a central role in several processes altered in 
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PTSD. Prefrontal hypoactivity has been consistently 
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reported in patients with PTSD. Given that anodal tDCS stimulation is postulated to produce neuronal activation, whereas 
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cathodal tDCS induces hyperpolarization, anodal tDCS may reverse the PFC hypofunction seen in PTSD patients. 
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Overall, tDCS represents a novel and conceptually informed method to improve PTSD treatment outcomes, especially if 
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paired with an exposure-based psychotherapy.
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6. RESEARCH DESIGN.
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This study is an early phase II, two-arm, partially double-blind pilot RCT to explore the safety, feasibility, and effects of 
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tDCS vs. sham delivered in combination with WET among individuals seeking treatment for PTSD. As seen in Figure 1, all 
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individuals will complete a phone screen to learn more about the study to include the inclusion and exclusion criteria. 
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Study candidates will be recruited from the University of Texas Health Science Center at San Antonio (UTHSCSA) 

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Psychiatry Outpatient Clinics, and the San Antonio community. Participants will be recruited from the South Texas 
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Veterans Healthcare System (SVTHCS) by responding to flyers approved and posted by Public Affairs. Interested 
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participants who appear to meet eligibility criteria will be consented and then complete a baseline assessment to 
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determine study eligibility. Eligible participants will be randomized to five weekly sessions of tDCS, or sham, combined 
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with WET for PTSD. tDCS (or sham) will be simultaneously delivered during the writing exposure portion of WET for 30 
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minutes each session. Outcomes to address study objectives will include (1) safety as measured by the adverse events 
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(AE) monitoring logs, (2) feasibility based on study recruitment (number of contacted referrals who were eligible to begin 
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the full baseline assessment over the total number of contacted referrals [will not to include non-contact referrals]), 
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screening (number screened eligible following baseline assessment over the total number of individuals who completed a 
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baseline assessment), and treatment completion (number who completed all 5 sessions over total randomized), and (3) 
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the associated effects of tDCS for PTSD as measured by the PCL-5 and physiological stress response (as measured by 
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heart rate and galvanic skin response). Assessments will be collected twice to satisfy study aims at baseline and one-
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month follow-up. Select measures will also be administered during treatment (Table in section 7.3). 
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6.1.1. Randomization. This study will use a partially double-blind randomization design. All participants will be blinded to 
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treatment arm. With the exception of one non-clinical, research team member, all other members of the research team will 
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also be blinded to treatment arm.  This approach is so that the PI and research team can be quickly made aware of which 
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treatment arm the participant is assigned to in the event of an emergency.  
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7. RESEARCH PLAN.
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7.1.1. Subject Population. Participants will be individuals 18-65 years old who meet diagnostic criteria for PTSD on the 
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Clinician Administered PTSD Scale (CAPS-5). Efforts will be tailored to equally recruit diverse individuals across sex, 
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gender/sexual orientation, race, age, disability, socioeconomic status, national origin, and branch of military service.
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7.1.2. Inclusion and Exclusion Criteria. 
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Inclusion Criteria
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Individuals between the ages of 18 and 65 years old at time of screening.
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PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
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Able to write, read, and speak English. 
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Exclusion Criteria
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History of epilepsy or seizures.
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History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., 
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Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer’s, Dementia, Parkinson’s, and/or 
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Huntington’s).
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History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
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Electronic implants in the body that could be susceptible to electrical current  (e.g., cardiac pacemaker, cochlear 
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implants, medical pump).
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Metallic objects other than dental appliances/fillings near the site of stimulation
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Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined 
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by clinical judgement).
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Current moderate or severe substance use disorder.
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Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided 
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by the study treatment.
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Change in anticonvulsive or benzodiazepine medication regimen in the past month. 
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10. History of adverse effects to previous tDCS or other brain stimulation technique.
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11. Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
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12. Currently pregnant or breastfeeding.
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7.1.3. Description of the Recruitment and Prescreening Process. Participants will be recruited through the UTHSCSA 
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Outpatient Psychiatry Clinics located on the 7th Floor of the Medical Building and University Park Plaza (i.e., Advance Clinic, 
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Be Well Clinic, Transitional Care Clinic), and the San Antonio community through provider referrals, recruitment events, and 
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flyers. Participants will be recruited from the South Texas Veterans Healthcare System (SVTHCS) by responding to flyers 
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approved and posted by Public Affairs. Providers can give their patients contact information for the study staff so that 
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interested individuals may contact STRONG STAR directly. Alternatively, providers can obtain consent-to-contact from their 

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patients that allows the study staff to contact the potential participant directly. Co-Investigator, Melissa Martinez, MD, a 
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psychiatrist, Professor, and the Director of the Interventional Psychiatry Program at UTHSCSA, which offers brain stimulation 
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interventions for patients with PTSD and other psychiatric diagnoses, will also refer participants for the study. Individuals who 
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are not eligible or interested in other IRB-approved STRONG STAR protocols will be told about this study. Study information 
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will be posted on the STRONG STAR website and social media. Patients can self-refer themselves to the study. Under an 
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IRB-approved HIPAA Waiver of Authorization, study personnel will initially conduct a brief telephone interview where the basic 
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study inclusion/exclusion criteria will be reviewed. This will mitigate unnecessary travel and more in-depth screening for 
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individuals. Participants who appear eligible after telephone pre-screening will be invited into the STRONG STAR clinic to 
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provide written informed consent and undergo more rigorous assessment for study eligibility.
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7.1.4. Consent Process. During the consent appointment, potential participants will have the study explained to them in a 
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private location in-person at the UTHSCSA STRONG STAR offices located at 7550 IH10 West, Suite 1325, San Antonio, 
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TX 78229. The potential participant will be given a copy of the informed consent document (ICD) to read. After the 
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potential participant has read the ICD, and a member of the study team has reviewed the risks and benefits of the study to 
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ensure the participant understands the research, the participant will be given the opportunity to discuss the research with 
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family and friends. The research team will be available to answer any questions about the research. Once the potential 
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participant has reached a decision, the participant will sign the consent form. A copy of the signed ICD will be given to the 
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participant.
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7.1.5. Subject Screening Procedures. Following consent, a baseline assessment will take place to determine participant 
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eligibility. The entire screening process will take approximately 4 hours. This will include the completion of the 
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questionnaires, interviews, and screening tests outlined in the Table of Assessments below (see section 7.3). The 
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baseline assessment may occur in-person using paper forms, or the participant will be logged into the STRONG STAR 
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eCAP online data capture system to complete self-report questionnaires. For individuals not meeting study inclusion 
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criteria, the study staff will assist coordinating appropriate care outside of the study. If the participant has been referred 
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from another STRONG STAR study and already undergone baseline testing within the past 30 days, the participant will be 
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asked as part of the consent process to use these assessments rather than repeating the assessment battery. If the 
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participant is newly referred to this study, if it has been more than 30 days since baseline testing for another study, or the 
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participant declines use of previously completed assessments, he or she will meet with an evaluator and complete the full 
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baseline assessment per protocol.
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7.1.6. Source of Research Material. All measures will be administered for research purposes. For a complete list of 
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measures see Section 7.3.
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7.1.7. Compensation for participation. Participants will be paid $25 for physiological assessment of Heart Rate and 
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Galvanic Skin Response at sessions 1, 3, and 5 for a total of up to $75. Payment will be provided via a rechargeable 
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MasterCard® ClinCard. The MasterCard® ClinCard is a debit card issued to the study participant. Funds are loaded onto 
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card through the ClinCard website at www.clincard.com. Only authorized users will be able to access the ClinCard 
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website to add funds with a username and password. The ClinCard funds will be available to recipients within 1 business 
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day and can be used as the participant chooses. The participant will be notified that their name, address, and date of birth 
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will be shared with a third-party (ClinCard) solely for the purposes of payment processing. This information will only be 
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used for the administration of the payment and will be kept strictly confidential. 
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7.2 Study Device Overview. Transcranial Direct Current Stimulation (tDCS) will be the active intervention for this study. 
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tDCS will be administered using a Soterix 1x1 Transcranial Direct Current Stimulator Mini-Clinical Trials (Model 1601) and 
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two 5cm x 7cm Soterix SNAPpad electrode sponges soaked in saline solution that are secured to the head with the 
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Soterix SNAPstrap. SNAPpad sponges have a pre-inserted carbon rubber snap electrode that connects directly to the 
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designated electrode montage site on the SNAPstrap. The SNAPstrap is a customized head-gear strap positioned to 
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target the designated tDCS area. The SNAPstrap includes fixed electrode sites and built-in cabling for simple and 
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consistent device set-up. Soterix is an established, reputable medical brand that provides medical grade quality 
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transcranial electrical stimulation devices. The Soterix 1x1 includes programmable intensity (2.0mA) and duration (30 min) 
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features so that each stimulation session is standardized, as well as contact quality monitoring to ensure the electrodes 
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are secured prior to and during the session. The device includes a sham condition setting to enable a matched tDCS 
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sham waveform that allows for flexibility in testing in a research study. The device also has an abort option, which will 
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terminate the session and ramp down the device, as necessary.
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Medical devices, such as tDCS, are regulated by the FDA regardless of indications for use. We are requesting that the 
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IRB consider an “Investigational Device Exception (IDE)” for tDCS. See completed Form P, “Use of an IDE in Research.” 
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Based on other studies conducted in the US, the IRBs have designated tDCS to be of nonsignificant risk (see Fregni et 
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al., 2015). We are not seeking a new indication for tDCS with the data from this research project.
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7.3. Study Procedures/Research Interventions. The intervention to be tested in this study is Transcranial Direct Current 
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Stimulation (tDCS). tDCS procedures and dose for this study will be consistent with conventional published clinical 
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practice guidelines (≤40 min, ≤4 mA; Bikson et al., 2016) and will be delivered in combination with Written Exposure 
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Therapy (WET), an evidence-based, trauma-focused psychotherapy for PTSD (Sloan & Marx, 2019). 
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For this study, individuals will complete the following procedures at each session. 
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
Upon arrival, participants will complete self-report measures prior to their session as described in Table 7.3. 
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
Consistent with the WET protocol, session 1 will be 90-minutes while sessions 2-5 will be 60-minutes. All 
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sessions will include a 30-minute intervention of tDCS (or sham) plus written narrative followed by approximately 
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15-30 minutes to review writing with a study therapist. Session 1 includes psychoeducation on PTSD and review 
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the treatment rationale (approximately 30-45 minutes) at the beginning of the session (prior to the writing), while 
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subsequent sessions (2-5) begin with the writing.
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The tDCS (or sham) intervention will be delivered during the written narrative portion of each session. A trained 
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study team member will prepare the participant for tDCS after review of psychoeducation/rationale in session 1 
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and prior to sessions 2-5. Two electrodes in saline-soaked sponges (SNAPpads) will be placed on the participant 
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scalp. The anode will be placed over the left dorsolateral prefrontal cortex (lDLPFC) while the cathode will be 
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placed over the right dorsolateral prefrontal cortex (rDLPFC), consistent with previous work (Ahmadizadeh et al., 
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2019). The electrodes will be secured to the head using customized straps (SNAPstraps) designated to target the 
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desired brain regions. As described in Section 7.2, electrode and strap procedures will be completed using 
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standardized, preset equipment to maximize efficiency and reproducibility of positioning.
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Next, the study team member will place the HR and GSR device on the individual’s non-writing hand and begin 
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monitoring. The participant will then begin the writing exposure and tDCS device will be activated. The Soterix 
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device has standardized programming so that all participants receive the same dose (or sham) and intervention 
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based on the set procedures. The tDCS device will be set at 2.0mA for a total of 30-minutes. Once the “start” 
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button is clicked by the study team member, the device is programmed to gradually ramp up current to the set 
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intensity dose (2.0mA in this study) in the first 30-seconds. As seen in Figure 1, in the active intervention the 
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current will remain at 2.0mA for 30-minutes and then the programmed device will gradually ramp down from 
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2.0mA to 0.0mA in the final 30-seconds.
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Figure 1. tDCS active condition
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As seen in Figure 2, during sham stimulation, participants will experience the gradual current ramp up from 0.0 
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mA to 2.0mA in the first 30-seconds and then a gradual ramp down from 2.0mA to 0.0mA (30-seconds). The 
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programmed device will automatically repeat this process at the end of the set duration of 30 minutes.
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Figure 2. tDCS sham condition
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A study team member will be in the immediate proximity during tDCS (or sham)/written exposure to monitor 
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participant safety and abort the tDCS, if necessary. Clicking the “abort” button will initiate a ramp down of current 
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to 0.0mA. A medical provider will also be available should the participant experience a serious AE or require a 
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higher level of medical care.
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
Following the tDCS (or sham) and writing, a study team member will remove the tDCS and HR/GSR device. 
327
Consistent with WET, the participant will meet with a study therapist to review their writing for 15-30 minutes. 
328
During this time, the participant will also be monitored for safety prior to leaving the appointment. 
329
330
7.3.1 Collection of Human Biological Specimens. Females will complete a CLIA-waived hCG pregnancy test at baseline for 
331
screening eligibility purposes. 
332
333
7.3.2 Data Collection. See Table in Section 7.3 for a summary of the assessments and timing of administration. The data 
334
collected in the study will be coded using an assigned number. Hard copies of data collected during the study will be 
335
securely stored in locked cabinets at the STRONG STAR offices. Data will be entered into the STRONG STAR database 
336
by a member of the research team. 
337
338
7.3.2.1 Instrumentation. See the table in Section 7.3 for a summary of the assessments and timing of administration. A 
339
description of each of the assessments can be found at the end of this protocol. Assessments will be administered in 
340
person whenever possible. However, to accommodate participant schedules and/or instances in which a participant does 
341
not reside in the local area at the time of a follow-up assessment, we may collect full or partial assessments in person or 
342
via phone, video conferencing, and/or electronic data capture using a secure link to the encrypted STRONG STAR 
343
database. Reasonable efforts will be made to collect all data as described in this protocol, but we expect some 
344
participants may not be able to complete part or all of any given follow up assessment.
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Visit/Assessment/Follow Up (F/U) Interval
Study Day 
Pre/BL
S1
S2
S3
S4
S5
Post
Informed Consent
R
Interventions
tDCS/Sham
R
R
R
R
R
WET
R
R
R
R
R
Clinical Interviews
1.
Clinician Administer PTSD Scale-5 (CAPS-5)
S,R
R
2.
STRONG STAR Health Questionnaire
S,R
R
3.
Health Questionnaire Addendum for tDCS
S,R
4.
Self-Injurious Thoughts and Behaviors Interview 
(SITBI)
S,R
R
Self-Report Questionnaires
5.
PTSD Checklist-5 (PCL-5)
R
R
R
R
R
R
R
6.
Patient Health Questionnaire-9 (PHQ)
S,R
R
R
R
R
R
R
7.
Generalize Anxiety Disorder-7 (GAD)
R
R
R
R
R
R
R
8.
Posttraumatic Cognitions Inventory (PTCI)
R
R
R
R
R
R
R
9.
Depressive Symptom Index-Suicidality Subscale 
(DSI-SS)
S,R
R
R
R
R
R
R
10. Adverse Events Monitoring
R
R
R
R
R
R
11. tDCS Reaction Monitoring
R
R
R
R
R
12. Demographics Questionnaire
S,R
13. Life Event Checklist-5 (LEC)
R
R
14. Brief Inventory of Psychosocial Functioning (B-IPF)
R
R
15. Quick Drinking Screen (QDS)
R
R
16. Drug Abuse Screening Test (DAST)
S
17. Insomnia Severity Index (ISI)
R
R
18. Cognitive Emotions Regulation Questionnaire 
(CERQ)
R
R
19. History of Head Injuries
R
20. Neurobehavioral Symptom Inventory
R
R
21. Numeric Rating Scale for Pain Intensity
R
R
22. PROMIS Pain Interference Short Form 8a
R
R
23. Credibility and Expectancy Questionnaire for WET 
(CEQ)
R
24. Credibility and Expectancy Questionnaire for tDCS 
(CEQ)
R
Physiological/Biological Measures
25. Heart Rate
R
R
R
26. Galvanic Skin Response
R
R
R
27. hCG Pregnancy Test*
S
Notes. S=Screening Purposes, R=Research Purposes; Pre/BL= Baseline Assessment, S=session, Post = one-month 
post-treatment follow-up; Heart Rate and Galvanic Skin Response measurement will occur during the writing portion of 
sessions 1, 3, and 5, using Fitbit wrist watch; *Females only. 
346
347
7.3.2.2 Data Storage, Access and Protection. Study files containing hard copies of data collected during study 
348
participation will be kept securely at the STRONG STAR offices in San Antonio. Files will be placed into locked cabinets 
349
and stored securely in a locked room by a STRONG STAR staff member. Data will be coded using an assigned number. 
350
Local study sites will maintain a list of assignment numbers for the purpose of linking subsequent research materials. Data 
351
will be entered into the STRONG STAR password protected database housed on a secure UTHSCSA server by member 
352
of the research team. Electronic data will be stored, managed, and analyzed by the STRONG STAR Data and Statistics 
353
Services staff of the STRONG STAR consortium. The overall PI and named collaborators will have access to identifiable 
354
data through the STRONG STAR website and UTHSCSA server via direct request to STRONG STAR Data and Statistics 
355
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357
All UTHSCSA STRONG STAR network connectivity is segmented with Access Control Lists and is not accessible to any 
358
other UTHSCSA network segments. The STRONG STAR data server is physically located at the Advanced Data Center 
359
(ADC), which has 24x7 onsite security, card key, biometric access controls and video surveillance. UTHSCSA ADC facility 
360
also maintains Gen 2 firewall devices to protect and prohibit any unauthorized access to UTHSCSA data. All UTHSCSA 
361
network devices are monitored by state-of-the-art monitoring applications that include configuration audit, management, 
362
and availability 24x7. The UTHSCSA STRONG STAR data server is currently a VMware Instance running Windows 
363
Server 2018 Enterprise Standard with daily backup services and vSphere Business Continuity Advanced Failover.
364
365
Only select STRONG STAR Data and Statistics Services personnel have direct access to the data on a “need to access 
366
basis”; for example (but not limited to) detecting and repairing data corruption and producing reports not currently within 
367
the STRONG STAR system. STRONG STAR Data and Statistics Services also follows the Principals of Least Privilege 
368
(POLP). All user activity is tracked and recorded within the system so if any records are added, altered, or viewed the 
369
action is recorded and can be recalled for auditing purposes. Access to this information will require a password-protected 
370
login available only to authorized STRONG STAR Data and Statistics Services staff. 
371
372
Every member of the Research Team will be trained and monitored about how to handle and protect both research 
373
records. Furthermore, the Research Team strictly controls access to study data. The STRONG STAR Data Safety and 
374
Monitoring Plan (DSMP) that has been developed in accordance with the National Institutes of Health Office of Human 
375
Research Protection to assure the appropriate clinical safety monitoring of study subjects participating in research will be 
376
used to monitor this study.
377
378
7.4 Statistical Consideration
379
380
7.4.1 Sample Size Estimation.
381
Total Required to Consent
50
Estimated Participant Screen Fail / Exclusion (20%)
10
Target Sample Size to be Randomized
40
Estimated Participant Drop Out / Withdrawal after randomization (15%)
6
Expected Treatment Completers
34
382
383
7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints (See Table in section 7.3). Adverse event 
384
(AE) monitoring will address study Aim 1. To assess study feasibility (Aim 2), we will track study recruitment (number of 
385
eligible referrals/total referrals), enrollment (number of screened enrolled participants/total eligible), and treatment 
386
(number of participants who completed all 5 WET sessions). The PCL-5 (Weathers, Litz, et al., 2013) will be the primary 
387
outcome to assess PTSD severity (Aim 3a). Heart rate (HR) and galvanic skin response (GSR) will be used to address 
388
Aim 3b. 
389
390
7.4.3 Data analysis. 
391
Power Analyses: This pilot study is not powered for formal efficacy or mechanistic hypotheses testing. Consistent with 
392
research regarding the purpose of a pilot study, our main interests were to evaluate the feasibility of the proposed recruitment, 
393
assessment, and treatment protocols, examine safety, and to explore a detectable effect of tDCS across outcomes in 
394
preparation for a larger trial (Kraemer et al., 2006; Leon et al., 2011). Although the statistical power of this study is limited, we 
395
will perform statistical analyses appropriate for an adequately powered study to identify data analysis issues germane to 
396
future planning. 
397
398
Data Analyses: Prior to developing statistical models, all variable distributions will be examined using frequency distributions, 
399
scatter plots, and histograms. Statistics such as means or proportions, standard errors, ranges, and estimates of skewness 
400
and kurtosis will be computed and used as guidelines in the application of analyses. Data transformation procedures may be 
401
applied to variables with considerable departure from normality. 
402
403
The objectives of this study are to evaluate the safety, feasibility, and PTSD symptom reductions associated with tDCS vs. 
404
sham. All statistical analyses will be intent to treat and include all participants randomized at baseline regardless of the 

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extent of study participation. Given the small sample size, we will use a Benjamini-Hochberg Adjustment procedure to 
406
mitigate the false discovery rate (two tailed initial p = .05). Analyses will be done SPSS 27 statistical software. As needed, 
407
we also have access to SAS 9.4, Stata 14.2, R, and Mplus 8.4 software.
408
409
Descriptive Statistics to Address Aims 1 and 2: Descriptive statistics will be used to address the safety and feasibility of 
410
tDCS when combined with WET. To assess, safety, we will evaluate the frequency, severity, and relatedness of AE based 
411
on the STRONG STAR AE monitoring procedures. AE logs will be reviewed and adjudicated with the study team during 
412
weekly meetings to evaluate reliable coding and participant safety. Casey Straud, PsyD (PI) and Melissa Martinez (Co-I; 
413
Attending Physician) will also hold one-on-one meetings as needed to mitigate health related AEs and monitor 
414
participants. To assess study feasibility, we will estimate recruitment (number of eligible referrals/total referrals), 
415
enrollment (number of screened enrolled participants/total eligible), and treatment (number of participants who completed 
416
all 5 WET sessions). Feasibility data will be used to inform planning for a larger clinical trial.
417
418
Generalized Linear Mixed Models (GLMM) to Address Aim 3: GLMM will be used to evaluate changes in continuous 
419
outcomes associated with tDCS vs. sham. GLMMs are a powerful and flexible statistical extension of linear mixed models 
420
that can examine outcome variables from different distributions, such as normal (continuous) and binary outcomes. 
421
Advantages of likelihood-based regression models over conventional ANOVA include the ability to use data from all 
422
participants even if they have only baseline data, relaxation of the assumption of equal variances before and after 
423
treatment, specification of data distributions other than normal such as Poisson or log-normal, and the ability to analyze 
424
longitudinal data in the presence of missing data given the assumption that data are missing at random. GLMM’s will 
425
include fixed effects of time, treatment (tDCS vs. sham), and the time by treatment interaction. Models will include a priori 
426
planned contrasts of mean differences over time and simple effects to evaluate treatment differences at each time point. 
427
To inform future studies, we will calculate conventional effect sizes with 95% confidence interval limits (Hertzog, 2008). 
428
Hedges’ g will be used to calculate continuous outcome effect sizes (e.g., PCL-5). Hedges’ g has been recommended 
429
over Cohen’s d for small samples based on sample size adjustments, yet can be interpreted using the same conventional 
430
recommendations as Cohen’s d, .20 =small, .50=medium, and .80=large effect sizes (Lakens, 2013).
431
432
Assessment timepoints are presented in the 7.3 Table. The PCL-5 will be the primary outcome to evaluate changes in 
433
PTSD severity from baseline assessment to one-month follow-up, with data points collected during treatment also 
434
included in models (Aim 3a). Heart rate monitoring and GSR will be used to evaluate physiological stress arousal during 
435
the writing exposure task (Aim 3b). Both physiological outcomes will be collected during the writing exposure portion of 
436
sessions 1, 3, and 5 to provide before, after, and peak estimates of physiological arousal. Time points of interest for 
437
physiological outcomes will be the immediate, long-term, and peak effects of tDCS. The immediate effect of tDCS will be 
438
defined as changes immediately prior to and after the first written exposure (i.e., change from T1 to T2), the third written 
439
exposure (change from T3 to T4), and the last time participants engage in writing exposure (change from T5 to T6). The 
440
long-term effect of tDCS will be defined as changes in physiological levels across sessions (session 1 to session 5) prior 
441
to engaging in the writing exposure (change from T1 to T5) and after the writing exposure (change from T2 to T6). The peak 
442
effect will evaluate change score differences (interaction effect) in the greatest estimate during session 1 to session 5.
443
444
7.5 Confidentiality. Pretreatment (baseline) and posttreatment (one-month follow-up) assessments will be primarily 
445
delivered in private offices at the STRONG STAR clinic at the UTHSCSA located at 7550 IH10 West, Suite 1325 in San 
446
Antonio, TX. tDCS or sham + WET sessions will be delivered in private offices at the STRONG STAR clinic. All treatment 
447
sessions will be completed in person. When travel to the STRONG STAR clinic is not feasible for the one-month follow-up 
448
assessment, video teleconferencing will be made available to mitigate missed appointments. Data will be stored by an 
449
assigned participant code number so that data records can be viewed by password-authenticated, authorized 
450
investigators and Consortium personnel. Digital audio recordings of assessments will be labeled with the participant’s 
451
study id number and saved on a secure password protected server. Those recordings may be reviewed for adjudication 
452
on PTSD diagnosis or to ensure that the assessment was delivered in accordance with training guidelines. Any 
453
assessment recordings will be viewed on a secure password protected server. There is no option for the reviewers to 
454
download or otherwise save the recordings to their computers. Every member of the research study team will be trained 
455
and monitored on how to handle and protect both medical and research records. Only authorized study staff, and 
456
members of the STRONG STAR Data and Statistics Services staff will have access to either the raw data or electronic 
457
study data. We are not seeking a Certificate of Confidentiality.
458
459
7.7.3. Long Term Data Storage. A STRONG STAR Repository has been approved by the UTHSCSA (HSC20100475H) IRB 
460
to enable the STRONG STAR Consortium to store specimens and data for future use. The STRONG STAR Repository is a 

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large comprehensive database of information, biological specimens and neuroimages related to the identification, 
462
assessment, and treatment of posttraumatic stress disorder (PTSD), insomnia, pain, and related behavioral health conditions. 
463
All information entered into the STRONG STAR Repository will be extracted from primary datasets collected as part of IRB-
464
approved studies, including this study, being conducted and /or supported in collaboration with the UTHSCSA STRONG 
465
STAR Consortium. Study databases are established and maintained by the Data Management and Biostatistics Core of the 
466
STRONG STAR Consortium. A unique, sequential alpha-numeric STRONG STAR ID will be assigned to each participant at 
467
the time of recruitment into this study. However, all Repository data will be identified with a different code number that can be 
468
cross linked to the original study code only through records maintained by the STRONG STAR Data Management and 
469
Biostatistics Core. At the conclusion of this study, participants who signed the consent to have their data placed in the 
470
STRONG STAR Repository will be maintained under the UTHSCSA IRB-approved Repository protocol. For participants who 
471
decline participation in the STRONG STAR Repository, at the conclusion of the study their data will be de-identified and the 
472
data maintained in the Repository without identifiers.
473
474
8.0 RISKS/BENEFITS ASSESSMENT
475
476
8.1 Risks. tDCS and WET are safe and well tolerated by human subjects, but are associated with minor, transient 
477
adverse effects. In human trials to date, the use of tDCS within the recommended clinical guidelines (≤40 min, ≤4 mA) has 
478
not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1,000 
479
subjects with repeated sessions. However, like many medical devices, AEs are possible. tDCS risk information presented 
480
below is aggregated from the following references (Ahmadizadeh et al., 2019; Bikson et al., 2016; DaSilva et al., 2011; 
481
Davis & Smith, 2019; Fregni et al., 2015; Thair et al., 2017). PTSD and WET risk information presented below is from the 
482
International Society for Traumatic Stress Studies (ISTSS) clinical practice guidelines (Forbes et al., 2020)
483
484
Likely, but Not Serious Risks (expected to occur in 15-30 out of 100 participants): 
485
486
tDCS: The most common adverse effect of tDCS include mild itching sensation at the point of contact with the electrodes. 
487
These AEs can be mitigated by excluding individuals with a history of skin condition, the use of saline solution, and 
488
limiting the intervention to 40 min or less with ~1-week in-between sessions. 
489
490
WET: Temporary increases in psychological distress can occur among individuals engaged in WET for PTSD.
491
492
Less Likely, some may be Serious (expected to occur in 10-18 out of 100 participants): 
493
494
tDCS: Transient minor discomfort can occur in about 10-18% of participants, such as mild headaches, nausea, mild 
495
burning sensation at the point of electrode contact, and fatigue. However, the relatedness of AEs to tDCS remains unclear 
496
as many controlled trials have demonstrated no difference between the tDCS and sham conditions.
497
498
Rare and Serious (expected to occur in <1 out of 100 participants): 
499
500
tDCS: A rare but serious AE of tDCS can be skin lesions following repeated tDCS. As noted above, the risk of both skin 
501
lesions and itching/burning sensations can be minimized by soaking the connecting sponges in sodium chloride (saline) 
502
solution rather than water before commencement of stimulation. Another potentially serious AE that has been discussed 
503
in the literature is seizures. To date, there is no documented evidence that tDCS has resulted in a seizure and this may be 
504
explained by the subthreshold current used in tDCS. However, there is a theoretical rationale that brain stimulation can 
505
increase the risk of seizures. 
506
507
Risks to Confidentiality: With the handling of medical and research records there is always the possibility of a breach of 
508
confidentiality. We will maintain patients’ names, contact information (i.e., Identifiers), and all PHI (protected health 
509
information) in an encrypted computer database and all PHI identifiers will be removed in the database during data 
510
analysis. Every member of the Research Team is carefully trained and monitored about how to store, handle, and protect 
511
participant records.
512
513
Risks of PTSD Diagnosis regardless of Treatment: One of the risks of PTSD both in and out of treatment is attempted 
514
suicide, which can result in death. Increased suicidality is possible during study participation.
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Safeguards for Protecting Participants: Based on existing literature on tDCS, WET, and PTSD, we have developed 
517
exclusionary criteria and safety protocols to mitigate, regularly screen, and respond to possible risks that may occur 
518
during study participation.
519
520
tDCS: To safeguard against potential tDCS risks, we have developed exclusionary criteria related to the individual’s 
521
medical, psychiatric, and substance use history and known contraindications to brain stimulation (see 7.1.2 Inclusion and 
522
Exclusion Criteria). Furthermore, prior to enrollment in the study, Melissa Martinez, MD (Co-I, medical attending) and 
523
Casey Straud, PsyD (PI) will review participants’ assessment materials to confirm eligibility. In addition to eligibility 
524
determination, we will also implement safety procedures during study participation. Participants will be monitored for AEs 
525
at each treatment session and the one-month follow-up appointment. Reported AEs will be adjudicated at weekly study 
526
team meetings. In these meetings additional safety monitoring of a participant may be developed. Individuals will also 
527
complete the tDCS Reactions form at the end of each session to assess safety. Furthermore, the device includes 
528
programmable features (intensity and duration) to mitigate session variation and the tDCS equipment includes 
529
standardized presets for efficient and reliable electrode positioning. A study team member will also be in immediate 
530
proximity of the participant during tDCS should they require assistance or experience a serious AE. The device also has 
531
an abort button that can terminate the session and ramp down the current, as needed. Lastly, we will also monitor 
532
individuals for 15-30 minutes following tDCS prior to leaving the appointment. This portion of the appointment aligns with 
533
the WET protocol but allows for additional time to monitor the participant for AEs. In the event it is determined the 
534
individual requires emergency medical services, 911 will be alerted so that the individual can be taken to the nearest 
535
emergency department (e.g., University Hospital). 
536
537
The risk for the mild itching sensation at the point of contact with the electrodes will be mitigated by excluding individuals 
538
with a history of skin condition, the use of saline solution, and limiting the intervention length to 30 min with ~1-week in-
539
between sessions.
540
541
WET: Psychological distress experienced by participants is expected to be temporary and participants will be provided 
542
immediate coping tools and techniques to manage distressing emotions by the study therapist. Any indication that the 
543
participant is considering suicide, endorses active psychosis/mania, or other harm to self/others will be handled using 
544
evidence-based procedures and policies developed by the STRONG STAR Consortium. Participants who endorse 
545
mania/psychotic symptoms will prompt a clinical interview with a licensed clinical provider to assess current risk and risk 
546
of active mania/psychosis during study participation. Individuals with active mania/psychosis will be excluded from study 
547
participation.  Trained clinicians and evaluators will assess history of suicide and current suicidal ideation using the 
548
Suicidal Ideation Thoughts and Behaviors Interview at the baseline assessment. Prior to each session individuals will also 
549
complete self-report questionnaires to monitor PTSD, depression, and suicidality symptoms. Participants identified as low 
550
to moderate risk for suicide based on the assessment results may be maintained on the protocol and additional risk 
551
management procedures will be implemented within the context of the study treatment. For participants identified as being 
552
at high risk for suicide based on the assessment results, disenrollment will be considered if it is unlikely that standard 
553
treatment plus additional risk management procedures will maintain safety. High risk participants who are disenrolled from 
554
the study will be referred for more intensive treatment (outpatient or inpatient). 
555
556
For urgent issues that occur in between appointments, whether related to tDCS or WET, participants will be instructed to 
557
get help immediately by going to the nearest emergency room. All participants will be given a study device emergency 
558
department wallet card at the beginning of the study. Participants will be instructed to keep this card on their person 
559
throughout the study. The wallet card briefly describes the study intervention (tDCS vs. sham) and provides a study team 
560
contact number.
561
562
8.2 Potential Benefits. Potential benefits of participation in this study may include a reduction in, or amelioration of, 
563
PTSD symptoms over the course of therapy. Collectively, the possible risks (i.e., temporary increase in distress and 
564
severity) associated with participation are low and reasonable within this context given the level of participant monitoring 
565
and access to research and clinical staff. We believe that the possible benefits from participating in this study significantly 
566
outweigh the possible risks. The knowledge gained from this study will serve to inform the most effective early 
567
interventions for the prevention and treatment of PTSD in military veterans.
568
569
8.3 Alternatives. Other choices to participating in this study include: not participating in this study; receiving 
570
psychotherapy or medications in the community; or participation in other research studies involving experimental 
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9.0  ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS. 
574
Adverse Events will be assessed and monitored according to the established STRONG STAR and SOP and the IRB of 
575
record’s policies and procedures. 
576
577
9.1 Reporting Unanticipated Problems Involving Risks to Subjects or Others, Serious Adverse Events and Deaths to 
578
the IRB Office. All adverse events, unanticipated problems involving risk to subjects or others, and deviations will be reported 
579
to the Institutional Review Board (IRB) in accordance with current IRB policy. UPIRSOs and recurrent non-compliance with 
580
study procedures will be reported promptly to the IRB. All adverse events that do not meet the UPIRSO criteria and deviations 
581
that are not non-compliance will be summarized at Continuing Review per the IRB of record’s policy.
582
583
10.0 WITHDRAWAL FROM STUDY PARTICIPATION. 
584
Participation in the study may be discontinued by the principal investigator if continued participation is considered a 
585
danger to a participant’s welfare. Reasons for discontinuation include: 1) a serious AE such that continued participation 
586
would be a danger to the participant; 2) clinical worsening for any reason that is deemed to necessitate non-study 
587
psychological or medical treatment; 3) exacerbation of PTSD, anxiety, or depressive symptoms that the participant cannot 
588
tolerate; or 4) discontinuation would be in the participant's best interest. Participants deemed candidates for 
589
discontinuation will be discussed in conference calls with relevant study team members and will be brought to the 
590
attention of the PI and Co-I’s for discussion and final decision. Participants who are discontinued from the study for any 
591
reason will be scheduled for a final evaluation within one week and given appropriate treatment referrals. If participants 
592
are discontinued due to a serious AE, they will continue to be followed clinically by the therapist and/or member of the 
593
research staff until the AE is resolved or becomes stable. The reason the participants are discontinued from the study will 
594
be documented for future study planning.
595
596
11.0 TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis). 
597
The following table provides an overview of activities that the research team plans to accomplish. This funding mechanism is 
598
for two years. Funds will be transferred following IRB approval. Therefore, we have accounted for a 6 month “pre-award” 
599
period to submit for IRB approval, prepare study materials, and train staff in the table below, with the study time period 
600
initiating upon award transfer. We anticipate recruiting and treating 2-3 eligible participants per month to meet study goals.
601
Pre
Award
Start
Year 1
Year 2
Study Activities (Months)
6 months
0-3
4-6
7-9
10-12
13-15
16-18
19-21
22-24
IRB Approvals, Prepare Materials, Train Staff
Recruit, Screen, and Treat 40 Participants 
X
X
X
X
X
X
Follow-up Assessments
X
X
X
X
X
X
Data Cleaning and Analysis
X
X
X
X
602
603
12.0 STUDY CLOSURE PROCEDURES. 
604
At the end of the study all data will be stripped of identifiers. De-identified (anonymized) data will be maintained indefinitely in 
605
the STRONG STAR Repository. Informed consent documents will be stored securely for a minimum of three years following 
606
completion of the research in accordance with 45 CFR 46 or in accordance with institutional requirements, whichever is 
607
longer. HIPAA authorizations will be stored for a minimum of six years in accordance with HIPAA regulations or in accordance 
608
with institutional requirements, whichever is longer. A Final Report will be submitted to the IRB to request inactivation of the 
609
study.
610
13. FUNDING. 
611
This project is funded as part of a program award titled “Transcranial direct current stimulation for the treatment of post-
612
traumatic stress disorder – from rodent models to clinical studies” through Center for Biomedical Neurosciences at UTHSCSA 
613
(Co-PIs: Casey Straud, PsyD, ABPP; Daniel Lodge, PhD; Flavia Carreno, PhD).  
614
615
14.0 DESCRIPTION OF ASSESSMENTS. 
616
The majority of the measures listed below are commonly used, have adequate to good psychometrics, and are part of the 
617
Consortium common data elements (CDE). As outlined in the National Research Action Plan, evidence-based CDEs and 
618
measures for STRONG STAR studies will ensure comparability of results across the consortium as well as other clinical 
619
trials and epidemiological studies of PTSD.
620

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14.1 Clinical Interviews: 
622
1.
The Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 (Weathers, Blake, et al., 2013)is 
623
structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 
624
(Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 
625
symptoms. Additional items that are not included in the total score evaluate overall symptom duration, distress, 
626
impairment, dissociative symptoms, and global ratings by the interviewer. Validation studies are nearly complete to 
627
establish the psychometric properties of the CAPS-5 and findings will be reported in peer-reviewed publications. This 
628
interview is very similar to its predecessor, the CAPS for DSM-IV, which has been considered the gold standard for 
629
evaluating PTSD and demonstrated good reliability and validity. In addition to reflecting diagnostic changes for PTSD 
630
in DSM-5, the CAPS-5 differs from the CAPS in that frequency and intensity ratings for each symptom are no longer 
631
scored separately, so the severity rating for each item determines whether a symptom is present or not. Subscale 
632
scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, 
633
avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis 
634
of PTSD. This measure will be administered at the baseline assessment and the one-month follow-up assessment.
635
636
2.
Health Questionnaire. The Health Questionnaire includes items regarding physical and mental health history, diagnoses, 
637
utilization of services, and military medical board evaluation/VA disability. For this study, the Health Questionnaire will be 
638
modified to assess civilian and military participants. Participants are asked about current medications being used and 
639
provide information on how long they have been taking the medication. The Health Questionnaire also asks about caffeine 
640
use and frequency of use in the past month. Overall, this measure provides a brief, yet comprehensive overview of the 
641
patient’s medical and psychiatric history as well as relevant information regarding caffeine use and medications. This 
642
measure will be administered at the baseline assessment and one-month follow-up.
643
644
3.
Health Questionnaire tDCS Addendum. The Health Questionnaire tDCS Addendum is an adapted extension of the Health 
645
Questionnaire and includes items relevant to the assessment of tDCS health contraindications. Items will assess for 
646
history of seizures, significant intracranial pathology (e.g., severe traumatic brain injury), major neurological conditions 
647
(e.g., Dementia), metallic objects in the body, skin conditions where electrodes are applied that could be exacerbated 
648
(e.g., eczema), and adverse reaction to brain stimulation. This measure will be administered at the baseline assessment.
649
650
4.
Self-Injurious Thoughts and Behaviors Interview (SITBI). The SITBI (Nock et al., 2007) is a structured interview assessing 
651
the presence, frequency, and characteristics of self-injurious and suicidal thoughts and behaviors. The SITBI will be 
652
administered by an Independent Evaluator, who will instruct the participants to answer the questions based on their entire 
653
lifetime of experience. The SITBI has shown high interrater reliability, test-retest reliability, and concurrent validity. This 
654
measure will be administered at the baseline assessment and the one-month follow-up assessment.
655
656
14.2 Self-Report Questionnaires: 
657
5.
PTSD CheckList-5 (PCL-5). The PCL-5 (Weathers, Litz, et al., 2013) is a 20-item self-report measure update of the PCL 
658
designed to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to 
659
have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD 
660
symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time 
661
points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 “not at all”) 
662
to 4 (“extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the 
663
one-month follow-up assessment.
664
665
6.
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 (Kroenke et al., 2001) is a widely used and well-validated instrument 
666
for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic 
667
symptoms related to depression and depressive disorders; these 9 items correspond to the diagnostic criteria for DSM 
668
MDD. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two 
669
weeks on a scale ranging from 0 (“not at all”) to 3 (“nearly every day”). Scores on all items are summed to obtain a total 
670
severity score. Scores reflect no significant depressive symptoms (0-4), mild depressive symptoms (5-9), moderate 
671
depressive symptoms (10-14), moderately severe depressive symptoms (15-19), and severe depressive symptoms (>19). 
672
Respondents also indicate the degree to which their depressive symptoms have made it difficult for them to do their work, 
673
take care of things at home, or get along with other people, from “not difficult at all” to “extremely difficult.” The PHQ-9 has 
674
high internal consistency (e.g., alpha ranging from .83 to .92) and correlates strongly with other measures of depression. 
675
This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-
676
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678
7.
Generalized Anxiety Disorder Screener (GAD-7). The GAD-7 (Spitzer et al., 2006) will be used to assess generalized 
679
anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been 
680
bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 (“not at all”) to 3 (“nearly every day”). 
681
Scores on all items are summed to obtain a total severity score. Scores reflect no significant anxiety symptoms (0-4), mild 
682
anxiety symptoms (5-9), moderate anxiety symptoms (10-14), and severe anxiety symptoms (>15). Respondents also 
683
indicate the degree to which their anxious symptoms have made it difficult for them to do their work, take care of things at 
684
home, or get along with other people, from “not difficult at all” to “extremely difficult.” The GAD-7 has been shown to have 
685
high internal consistency (e.g., α = .89) and has been shown to reliably discriminate between anxious and non-anxious 
686
diagnostic groups. This measure will be administered at the baseline assessment, prior to each therapy session, and the 
687
one-month follow-up assessment.
688
689
8.
Posttraumatic Cognitions Inventory (PTCI). The PTCI (Foa et al., 1999) is a 36-item questionnaire that was developed to 
690
determine how an individual views the trauma and its sequelae in an attempt to understand both how PTSD develops and 
691
is maintained. Using an emotional processing theory, Foa and her colleagues have suggested that PTSD is a 
692
consequence of disruptions in the normal processes of recovery when an individual has excessively rigid concepts about 
693
self and world rendering the person vulnerable if a traumatic event occurs. Thus, the PTCI was developed as a measure 
694
of trauma-related thoughts and beliefs. It is comprised of three subscales (Negative Cognitions about the Self, Negative 
695
Cognitions about the World, and Self-Blame). The measure was tested in almost 600 adult volunteers recruited from two 
696
university PTSD treatment clinics as well as a university community. Approximately 65% (n=392) of individuals reported 
697
having experienced a trauma in which their own life or that of another person was perceived to be in danger and their 
698
response at the time included intense terror, horror, or helplessness (Criterion A event). The remaining 35% (n=162) 
699
denied such a traumatic experience. Of those who had experienced a trauma, 170 had PTSD symptoms of at least 
700
moderate severity while the remaining 185 reported a low symptom severity. The three subscales of the PTCI 
701
demonstrated internal consistency with alpha coefficients ranging from .86 to .97. Convergent validity was demonstrated 
702
comparing the PTCI to appropriate subscales of the World Assumptions Scale and Personal Beliefs and Reactions Scale. 
703
Significant correlations between the appropriate subscales ranged from .20 to .85. The PTCI was able to differentiate 
704
individuals with and without PTSD demonstrating discriminate validity (sensitivity = .78, specificity = .93). Test–retest 
705
reliability for each of the three subscales at a 1-week interval ranged from 0.75 to 0.89 and for a 3-week interval ranged 
706
from .80 to .86. This measure will be administered at the baseline assessment, prior to each therapy session, and the 
707
one-month follow-up assessment.
708
709
9.
Depressive Symptoms Index-Suicidality Subscale (DSI-SS).The DSI-SS (Joiner & Metalsky, 1997) will be used to assess 
710
current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, 
711
perceived control over ideation, and impulses for suicide. It is being used as a core measure in the Military Suicide 
712
Research Consortium. Scores on each item range from 0 to 3, with higher scores reflecting greater severity of suicidal 
713
ideation. Instructions will instruct the participants to respond based on the past two weeks. A systematic review of 
714
measures of suicidal ideation and behaviors found that the DSI-SS had evidence of excellent internal consistency and 
715
concurrent validity. This measure will be administered at the baseline assessment, prior to each therapy session, and the 
716
one-month follow-up assessment.
717
718
10. Adverse Events Monitoring (AE). AEs will be assessed using the STRONG STAR AE monitoring procedures in order to 
719
evaluate safety of participants. Participants are asked, “Have you experienced any changes for the worse since your last 
720
visit?” All reported events are documented by the research team member. Participants also asked about the temporal 
721
nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to 
722
something else. AEs will be reviewed and adjudicated with the study team during weekly meetings to ensure reliable 
723
coding and participant safety. Melissa Martinez, MD (Co-I; Attending Physician and Casey Straud, PsyD (PI) will hold 
724
regular one-on-one meetings as needed to review medical-related AEs and monitoring of participants to mitigate health-
725
related AEs during the study. AEs will be administered prior to each therapy session, and at the one-month follow-up 
726
assessment.
727
728
11. Transcranial Direct Current Stimulation (tDCS) Reactions Monitoring. tDCS reaction monitoring will be assessed using a 
729
STRONG STAR SOP for monitoring to evaluate safety of participants. Participants will be asked to complete the form self-
730
report form at the end of the session. Participants who flag as at risk (elevated score on at least one item) on the form will 
731
be further assessed by a trained study therapist for safety. Individuals identified as at risk by study therapists will prompt a 
732
medical eyes on by the study nurse and/or Attending Physician to further determine the need for a higher level of medical 

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care. 
734
735
12. Demographics Characteristics Form. The Demographics Form measures standard demographics (race, gender, 
736
age). This measure will be administered at the baseline assessment.
737
738
13. Life Events Checklist-5 (LEC-5). The LEC (Gray et al., 2004) includes a list of 24 potentially traumatic life events 
739
commonly associated with PTSD symptoms. The instrument was designed to facilitate the diagnosis of PTSD. In this 
740
study, the LEC-5 will also be used to identify the index event and focus of the PTSD treatment. For each potentially 
741
traumatic life event, respondents rate their experience of that event on a 5-point nominal scale (1 = happened to me, 2 = 
742
witnessed it, 3 = learned about it, 4 =part of my job, 5= not sure, and 6 = does not apply). Each nominal point will be 
743
scored separately, as either 0 (=not endorsed by participant) or 1 (=endorsed by participant). This measure will be 
744
administered at the baseline assessment.
745
746
14. Brief Inventory of Psychosocial Functioning (BIPF). The BIPF (Marx, 2013) is a 7-item self-report instrument measuring 
747
respondents’ level of functioning in seven life domains: romantic relationship, relationship with children, family 
748
relationships, friendships and socializing, work, training and education, and activities of daily living. Respondents indicate 
749
the degree to which they had trouble in the last 30 days in each area on a 7-point scale ranging from “0 = Not at all” to “6 
750
= Very much.” This measure will be administered at the baseline assessment, and the one-month follow-up assessment.
751
752
15. Quick Drinking Screen (QDS). The QDS (Sobell et al., 2003) will be used to assess hazardous or harmful patterns of 
753
alcohol consumption in the past two weeks. The QDS is a four-item screener that assesses average number of drinking 
754
days, average number of drinks on drinking days, number of heavy drinking days, and greatest number of drinks in a day 
755
over the past two weeks. The average total drinks consumed per week can also be calculated by multiplying items 1 
756
(average number of drinking days per week) and 2 (average drinks per day). This measure will be administered at the 
757
baseline assessment and the one-month follow-up assessment. 
758
759
16. Drug Abuse Screening Test-10 (DAST-10). The DAST-10 (Skinner, 1982) is a 10-item self-report instrument with strong 
760
validity and reliability that was adapted from the 28-item DAST. The DAST assesses maladaptive use of drugs over the 
761
past 12 months. Items are rated as “No” or “Yes”. “Yes” responses are scored as “1” for all items except for item 3, which 
762
is reverse scored (No = “1”).  Total scores are calculated by summing all items and can be interpreted as follows: 0 = no 
763
problems reported; 1-2 (low level); 3-5 (moderate level); 6-8 (substantial level); and 9-10 (severe level). The DAST 
764
manual recommends that total scores ≥ 3 warrant further evaluation for a potential substance use disorder. This measure 
765
will be administered at the baseline assessment.
766
767
17. Insomnia Severity Index (ISI). The ISI (Morin et al., 2011) is a 7-item self-report measure that assesses perceived severity 
768
of insomnia. Each item uses a 4-point Likert type scale from 0 (not at all satisfied) to 4 (very much satisfied). The items 
769
sum to produce a total score (range 0 – 28). The ISI has an internal consistency alpha coefficient of .74 and has shown 
770
convergent validity with other measures such as the Pittsburgh Sleep Quality Index (r = .67), the Dysfunctional Beliefs and 
771
Attitudes about Sleep (r = .55), and sleep diaries (r ranges from .32-.91). This measure will be administered at the 
772
baseline assessment and the one-month follow-up assessment.
773
774
18. Cognitive Emotions Regulation Questionnaire-short form (CERQ). The CERQ-short form (Garnefski & Kraaij, 2006) is an 
775
18-item questionnaire that produces 9 subscales based on the original 36-item questionnaire. The CERQ self-report 
776
assesses cognitive coping strategies people tend to use, or what someone thinks, after having experienced threatening or 
777
stressful events. Item are rated on a 5-point Likert scale from 1 (almost never) to 5 (almost always) and produce nine 
778
subscale scores including: 1) Self-Blame, 2) Blaming Others, 3) Rumination, 4) Catastrophizing, 5) Positive Refocusing, 
779
6) Planning, 7) Positive Reappraisal, 8) Putting into Perspective, and 9) Acceptance. The higher the subscale score, the 
780
more a specific cognitive strategy is used. The CERQ has good internal consistency and convergent validity across 
781
subscales. This measure will be administered at the baseline assessment and the one-month follow-up assessment.
782
783
19. History of Head Injuries (HHI). The HHI (Schwab et al., 2006) is a modified version of the Defense and Veterans Brain 
784
Injury Center (DVBIC) 3-Item Screening Tool. Item 1 assesses if an individual has a history of head injury, the count of 
785
head injuries, and what caused the head injury. Item 2 assess post concussive symptoms that were sustained at the time 
786
of the worst event. Item 3 assess if the individual is currently experiencing post concussive symptoms. The HHI is positive 
787
when the participant endorses a history of head injury (question 1) and altered consciousness (question 2, items A-E) 
788
from the worst head injury sustained. The form was modified for this study for civilian and military samples (i.e., 

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deployment and non-deployment related head injuries were collapsed). The HHI has been identified as a gold standard 
790
for the diagnosis of TBI and has good concurrent validity. The HHI will be administered at baseline assessment. 
791
792
20. Neurobehavioral Symptom Inventory (NSI). The NSI (Cicerone & Kalmar, 1995) is a 22-item measure of behavioral, 
793
emotional, and cognitive post concussion symptoms related to a traumatic brain injury. Participants rate the degree they 
794
are impacted by each symptom on a 5-point Likert scale from 0 (None-rarely if present) to 4 (Very severe-almost always 
795
present and I have been unable to perform at work, school, or home due to this problem. I probably cannot function 
796
without help). The NSI total score is a summed score of the items (0 – 88 range), with greater scores indicating greater 
797
impact. The NSI has demonstrated good psychometric properties (King et al., 2012). The NSI will be administered at 
798
baseline assessment and one-month follow-up assessment.
799
800
21. Numeric Rating Scale for Pain Intensity (NRSPI). The NRSPI consists of three separate items that assess current pain, 
801
pain at its worst, and pain at its best. Each Item responses range from 0-10 with higher scores suggestive of greater pain 
802
severity. There is no total score calculated for this measure. The NRSPI will be administered at baseline assessment and 
803
one-month follow-up assessment.
804
805
22. Patient Reported Outcome Measurement Information System - Pain Interference Short Form 8a (PROMIS). The PROMIS 
806
(Amtmann et al., 2010) measures the self-reported consequences of pain on relevant aspects of a person’s life and may 
807
include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. 
808
All items assess pain interference over the past seven days on a Likert scale from 0 (Not at all) to 5 (Very Much). The final 
809
score is represented by a T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10.The 
810
PROMIS has demonstrated good psychometric properties. Th PROMIS will be administered at baseline assessment and 
811
one-month follow-up assessment.
812
813
23. Credibility/ Expectancy Questionnaire (CEQ) for WET. The CEQ (Devilly & Borkovec, 2000) is a 6-item measure that was 
814
designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies. This measure has 
815
been utilized across a number of STRONG STAR treatment trials and can be easily adapted to assess the target 
816
intervention(s). For the current proposed study, the CEQ will be adapted to assess the credibility and expectancy for tDCS 
817
and WET. These constructs will be assessed separately using two measures specific to each construct. The 6-item CEQ 
818
assesses both whether the person cognitively understands how the therapy works (credibility) as well as whether the 
819
person affectively believes that the therapy will work for them personally (expectancy). The 6-item CEQ has been tested 
820
in 217 individuals including 68 male Vietnam veterans and 58 female spouses, 69 individuals diagnosed with general 
821
anxiety disorder who had received treatment, and 22 individuals who had received either Cognitive Based Therapy (CBT) 
822
or Eye Movement Desensitization and Reprocessing (EMDR) for the treatment of PTSD. The scale demonstrated high 
823
internal consistency (alpha coefficients ranged from 0.84 to 0.85). Test-retest reliability over a one-week period was found 
824
to be 0.82 for expectancy and 0.75 for credibility. The CEQ was able to differentiate between two treatment rationales in 
825
one study, one with and one without an encompassing theory while maintaining equivalence between three rationales in 
826
another study. Responses to four questions are scored using a 9-point Likert scale (1= not at all, 9= extremely). 
827
Responses to two of the questions are scored using an 11-point Likert Scale (0% to 100%). The combined responses are 
828
used to generate a score for credibility and another score for expectancy. This measure will be administered prior to the 
829
second session.
830
831
24. Credibility/ Expectancy Questionnaire (CEQ) for tDCS. The CEQ (Devilly & Borkovec, 2000) is a 6-item measure that was 
832
designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies. This measure has 
833
been utilized across a number of STRONG STAR treatment trials and can be easily adapted to assess the target 
834
intervention(s). For the current proposed study, the CEQ will be adapted to assess the credibility and expectancy for tDCS 
835
and WET. These constructs will be assessed separately using two measures specific to each construct. The 6-item CEQ 
836
assesses both whether the person cognitively understands how the therapy works (credibility) as well as whether the 
837
person affectively believes that the therapy will work for them personally (expectancy). The 6-item CEQ has been tested 
838
in 217 individuals including 68 male Vietnam veterans and 58 female spouses, 69 individuals diagnosed with general 
839
anxiety disorder who had received treatment, and 22 individuals who had received either Cognitive Based Therapy (CBT) 
840
or Eye Movement Desensitization and Reprocessing (EMDR) for the treatment of PTSD. The scale demonstrated high 
841
internal consistency (alpha coefficients ranged from 0.84 to 0.85). Test-retest reliability over a one-week period was found 
842
to be 0.82 for expectancy and 0.75 for credibility. The CEQ was able to differentiate between two treatment rationales in 
843
one study, one with and one without an encompassing theory while maintaining equivalence between three rationales in 
844
another study. Responses to four questions are scored using a 9-point Likert scale (1= not at all, 9= extremely). 

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Responses to two of the questions are scored using an 11-point Likert Scale (0% to 100%). The combined responses are 
846
used to generate a score for credibility and another score for expectancy. This measure will be administered prior to the 
847
second session.
848
849
14.3 Physiological/Biospecimen Measures:
850
25. Heart Rate. Heart rate will be assessed using a wearable Fitbit wrist watch device. Heart rate data can be beneficial 
851
for individuals who report subjectively being more aroused during the exposure or behaviorally appear to be more 
852
activated. Heart rate was selected because it is a robust physiological factor associated with PTSD and stress that 
853
can be measured affordably and without specialized expertise. Heart rate will be assessed continuously during the 
854
written exposure portion of sessions 1, 3, and 5.
855
856
26. Galvanic Skin Response. GSR will be assessed using a wearable Fitbit wrist watch device. GSR data can also be 
857
beneficial for individuals who report subjectively being more aroused during the exposure or behaviorally appear to be 
858
more activated. GSR was selected because it is a robust physiological factor associated with PTSD and stress that 
859
can be measured affordably and without specialized expertise. GSR will be tracked using a wearable device to assess 
860
the pre, post, and peak arousal levels during session. GSR will be assessed continuously during the written exposure 
861
portion of sessions 1, 3, and 5.
862
863
27. hCG Pregnancy Test. Pregnancy will be assessed at the baseline appointment using a human chorionic gonadotropin 
864
(hCG), CLIA-waived pregnancy test. hCG pregnancy tests are a reliable and valid measure of pregnancy that 
865
evaluates hCG levels in the blood or urine and can determine whether a person is pregnant, as well as whether their 
866
body is producing the right level of pregnancy hormones.
867
868
15.0 REFERENCES. 
869
870
Ahmadizadeh, M. J., Rezaei, M., & Fitzgerald, P. B. (2019). Transcranial direct current stimulation (tDCS) for post-
871
traumatic stress disorder (PTSD): A randomized, double-blinded, controlled trial. Brain Research Bulletin, 153, 273–
872
278. https://doi.org/10.1016/j.brainresbull.2019.09.011
873
Amtmann DA, Cook KF, Jensen MP, Chen W-H, Choi SW, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai J-S 
874
(2010). Development of a PROMIS item bank to measure pain interference. Pain 150(1):173-82.
875
Asnaani, A., Reddy, M. K., & Shea, M. T. (2014). The impact of PTSD symptoms on physical and mental health 
876
functioning in returning veterans. Journal of Anxiety Disorders, 28(3), 310–317. 
877
https://doi.org/10.1016/j.janxdis.2014.01.005
878
Benjet, C., Bromet, E., Karam, E. G., Kessler, R. C., McLaughlin, K. A., Ruscio, A. M., Shahly, V., Stein, D. J., Petukhova, 
879
M., Hill, E., Alonso, J., Atwoli, L., Bunting, B., Bruffaerts, R., Caldas-de-Almeida, J. M., de Girolamo, G., Florescu, S., 
880
Gureje, O., Huang, Y., … Koenen, K. C. (2016). The epidemiology of traumatic event exposure worldwide: Results 
881
from the World Mental Health Survey Consortium. Psychological Medicine, 46(2), 327–343. 
882
https://doi.org/10.1017/S0033291715001981
883
Bikson, M., Grossman, P., Thomas, C., Zannou, A. L., Jiang, J., Adnan, T., Mourdoukoutas, A. P., Kronberg, G., Truong, 
884
D., Boggio, P., Brunoni, A. R., Charvet, L., Fregni, F., Fritsch, B., Gillick, B., Hamilton, R. H., Hampstead, B. M., 
885
Jankord, R., Kirton, A., … Woods, A. J. (2016). Safety of Transcranial Direct Current Stimulation: Evidence Based 
886
Update 2016. Brain Stimulation, 9(5), 641–661. https://doi.org/10.1016/j.brs.2016.06.004
887
Cicerone, K., & Kalmar, K. (1995). Persistent postconcussion syndrome: The structure of subjective complaints after 
888
mTBI. Journal of Head Trauma and Rehbilitation, 10, 1–17. http://dx.doi.org/10.1097/00001199-199510030-00002
889
Clark, C., Cole, J., Winter, C., Williams, K., & Grammer, G. (2015). A Review of Transcranial Magnetic Stimulation as a 
890
Treatment for Post-Traumatic Stress Disorder. Current Psychiatry Reports, 17(10), 83. 
891
https://doi.org/10.1007/s11920-015-0621-x
892
DaSilva, A. F., Volz, M. S., Bikson, M., & Fregni, F. (2011). Electrode positioning and montage in transcranial direct 
893
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