Atomoxetine in comorbid ADHD/PTSD: A randomized, placebo controlled, pilot, and feasibility study.

BACKGROUND: PTSD and ADHD often occur comorbidly. Research indicates that the cognitive deficits in PTSD may be related to the same disturbance of fronto-temporal systems as observed in ADHD, and ADHD has been shown to impact PTSD treatment outcomes. The presented study evaluated the safety and efficacy of atomoxetine in Veterans with comorbid ADHD/PTSD. METHODS: A double blind, randomized, placebo controlled, cross-over pilot and feasibility study was conducted. Atomoxetine was examined as an adjunctive treatment over this 10 weeks, two phase, crossover study which compared treatment with atomoxetine 80 mg daily to placebo daily. The primary outcome was improvement in ADHD symptoms as measured by the Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S), the Barkley Adult ADHD Rating Scale-IV (BAARS-IV), and the Adult ADHD Quality of Life-29 (AAQoL-29). Secondary outcomes included the Clinician Administered PTSD Scale (CAPS), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the response inhibition task Go/NoGo (GNG). RESULTS: Atomoxetine treated patients had greater reductions in ADHD symptoms as defined by total scores on the CAARS-S:S (F(1, 29) = 6.37, p = .017); both the BAARS-IV (F(1, 26) = 3.16, p = .087); and GNG overall errors test (F(1, 29) = 3.88, p = .06), reached a trend level of significance. No significant differences were noted in quality of life assessments, GNG latency periods, or CAPS scores. Atomoxetine was well-tolerated with no serious adverse events observed. CONCLUSIONS: In Veterans with ADHD comorbid with PTSD, atomoxetine demonstrated modest efficacy for ADHD symptoms; quality of life measures and PTSD symptoms were not affected.

Augmenting treatment efficiency in exposure therapy for PTSD: a randomized double-blind placebo-controlled trial of yohimbine HCl.

The alpha-2 adrenergic receptor antagonist, yohimbine, can facilitate fear extinction in animals and humans. One potential mechanism is increased noradrenergic activity and associated arousal in the presence of conditioned stimuli. Accordingly, yohimbine might augment prolonged exposure (PE) therapy for posttraumatic stress disorder (PTSD), where heightened exposure-oriented arousal is a theorized driver and empirical predictor of treatment success. A double-blind placebo-controlled randomized trial (NCT 01031979) piloted yohimbine augmentation in 26 males with combat-related PTSD. Participants were given one-time dose of yohimbine or placebo prior to the first imaginal exposure. Subsequently, both arms completed standard PE. The primary outcome was trauma-cued heart-rate reactivity a week after the drug/exposure visit, a highly specified, objective measure sensitive to incremental change. Secondary outcomes included arousal during the drug/exposure visit and slope of distress, PTSD, and depression over the course of PE. Consistent with hypothesis, yohimbine led to higher objective and subjective arousal during the drug/exposure visit and to lower trauma-cued heart-rate reactivity one-week later. One dose of yohimbine also led to greater between-session habituation and more rapid improvement on depression, but not PTSD, over the course of care. Results of this controlled pilot indicate support for continued investigation of yohimbine-augmented exposure therapy for PTSD.

Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans.

OBJECTIVES: Exposure-based psychotherapies for posttraumatic stress disorder (PTSD) are effective for many, but not all patients. It is important to determine for whom these treatments work and to examine predictors of success. METHOD: An 8-week modified prolonged exposure (PE) treatment, including components of behavioral activation and reducing the number of imaginal exposure sessions, was administered to a sample of 231 Veterans (mean age = 45.7 years, standard deviation = 14.89). Growth mixture modeling was used to model PTSD symptom trajectories across the 8-week intervention and a postintervention appointment. Further, baseline demographics, social support, clinician-rated PTSD symptoms, anxiety, and depression were examined as predictors of trajectories. RESULTS: Three classes emerged, labeled responders (n = 35), nonresponders (n = 190), and immediate responders (n = 6). The only significant baseline difference between responders and nonresponders was higher anxiety symptoms in the nonresponders. At follow-up time points, there were higher levels of clinician-rated PTSD, anxiety, and depression symptoms and lower social support in the nonresponders compared to the responders. CONCLUSION: Findings suggest that modifying standard PE treatments by reducing imaginal exposure sessions while adding behavioral activation may not be advisable for most Veterans with PTSD.

Trauma-related guilt: conceptual development and relationship with posttraumatic stress and depressive symptoms.

Despite high prevalence and concerning associated problems, little effort has been made to conceptualize the construct of posttraumatic guilt. This investigation examined the theoretical model of trauma-related guilt proposed by Kubany and Watson (2003). This model hypothesizes that emotional and physical distress related to trauma memories partially mediates the relationship between guilt cognitions and posttraumatic guilt. Using path analysis, this investigation (a) empirically evaluated relationships hypothesized in Kubany and Watson's model, and (b) extended this conceptualization by evaluating models whereby guilt cognitions, distress, and posttraumatic guilt were related to posttraumatic stress disorder (PTSD) symptoms depression symptom severity. Participants were male U.S. Iraq and Afghanistan veterans (N = 149). Results yielded a significant indirect effect from guilt cognitions to posttraumatic guilt via distress, providing support for Kubany and Watson's model (ß = .14). Findings suggested distress may be the strongest correlate of PTSD symptoms (ß = .47) and depression symptoms (ß = .40), and that guilt cognitions may serve to intensify the relationship between distress and posttraumatic psychopathology. Research is needed to evaluate whether distress specific to guilt cognitions operates differentially on posttraumatic guilt when compared to distress more broadly related to trauma memories.

Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder.

OBJECTIVE: Treatment engagement rates are low for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol use disorders across available interventions and treatment modalities. A better understanding of who does and does not engage in treatment can help improve retention, completion, and subsequent treatment outcomes. METHODS: Forty female survivors of intimate partner violence with PTSD and alcohol use disorder participated in a randomized controlled trial comparing twenty-five 90-minute sessions of either modified Seeking Safety or Facilitated Twelve-Step in a community-based outpatient clinic. This study examined differences in demographics and pre-treatment PTSD symptoms and alcohol use between participants who engaged in treatment (attended ≥ 6 sessions, n = 18) and those who dropped out (n = 22). RESULTS: There were no significant differences in PTSD or alcohol use disorder symptoms between treatment conditions. Women who engaged in therapy versus those who did not were significantly older (M = 46.2, SD = 9.14 vs. M = 38.95, SD = 10.49, respectively; p =.027), and had fewer dependents (M =.17, SD =.38, range = 0-1 vs. M =.95, SD = 1.66, range = 1-7, respectively; p =.046). Greater avoidance/numbing PTSD symptoms (OR = 1.13, p =.028, 95% CI [1.02-1.25]) and more years of heavy drinking (OR = 1.04, p =.03, 95% CI [1.00-1.07]) were also significantly associated with treatment engagement. CONCLUSIONS: This study replicates previous findings suggesting a need for additional retention strategies for younger women with dependents in comorbid PTSD and alcohol use disorder treatment. This is an analysis of data collected as part of a clinical trial registered as NCT00607412, at www.clinicaltrials.gov.

The role of alcohol expectancies in drinking behavior among women with alcohol use disorder and comorbid posttraumatic stress disorder.

Understanding how alcohol expectancies relate to alcohol use among individuals with concurrent alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) is important to understanding and treating this comorbidity. This study examined the role of positive and negative alcohol expectancies and PTSD symptoms in drinking behavior in a comorbid female sample. Participants were women (n = 33; 56% Caucasian) seeking AUD and PTSD treatment in an outpatient community co-occurring disorders program. Hypotheses related to drinking days and alcohol problems outcomes were evaluated using negative binomial hierarchical regression. PTSD symptoms were associated with fewer reported days of alcohol-related problems. Negative expectancies related to negative changes in social behavior associated with drinking days and cognitive and motor impairment associated with problems. Both the general positive expectancies score and specific global positive change subscale were uniquely associated with drinking and alcohol-related problems days after controlling for PTSD symptom severity and negative expectancies scores. Results suggest that both negative and positive expectancies about alcohol's effects are important correlates of drinking behavior among women with AUD and PTSD, with positive expectancies playing a potentially more salient role on use and consequences than symptom severity and negative expectancies.

Trauma Informed Guilt Reduction Therapy With Combat Veterans.

Guilt related to combat trauma is highly prevalent among veterans returning from Iraq and Afghanistan. Trauma-related guilt has been associated with increased risk for posttraumatic psychopathology and poorer response to treatment. Trauma Informed Guilt Reduction (TrIGR) therapy is a 4-module cognitive-behavioral psychotherapy designed to reduce guilt related to combat trauma. The goals of this study were to describe the key elements of TrIGR and report results of a pilot study with 10 recently deployed combat veterans. Ten combat veterans referred from a VA Posttraumatic Stress Disorder (PTSD) or mental health clinic completed TrIGR over 4 to 7 sessions. Nine veterans completed the posttreatment assessment. This initial pilot suggests that TrIGR may help to reduce trauma-related guilt severity and associated distress. Changes in trauma-related guilt were highly correlated with reductions in PTSD and depression symptoms over the course of treatment, suggesting a possible mechanistic link with severity of posttraumatic psychopathology. TrIGR warrants further evaluation as an intervention for reducing guilt related to traumatic experiences in combat.

A protocol for a randomized controlled trial of exposure and response prevention for veterans with obsessive compulsive disorder.

BACKGROUND: Obsessive compulsive disorder (OCD) is effectively treated with exposure and response prevention (ERP), yet very few veterans receive ERP for OCD within the Veterans Health Administration (VHA). Veterans are a clinically complex population, and no prior research has evaluated the effectiveness of ERP in veterans with OCD or comorbid OCD and posttraumatic stress disorder (PTSD). Given the limited accessibility of ERP-trained providers within VHA, assessment of video telehealth (VTH) delivery of ERP is warranted. METHODS: A sample of 160 veterans with OCD (80 diagnosed with comorbid PTSD) will be randomly assigned to receive up to 16 sessions of ERP or a stress management training control delivered via VTH. Assessments will occur at baseline, posttreatment, and 6-month follow-up. The primary outcome will evaluate the impact of ERP on participants' functioning, and secondary outcomes will include quality of life and OCD symptoms. At posttreatment, qualitative interviews with veterans, clinicians, and administrators will explore barriers and facilitators to treatment delivery, and the implementation potential of ERP. CONCLUSIONS: Results will provide direction for the treatment of OCD and comorbid PTSD in veterans, as well as guidance for future implementation efforts for ERP within VHA. CLINICALTRIALS: gov Identifier:NCT05240924.

If it's offered, will they come? Practical considerations when offering intensive PTSD treatment in an outpatient Veterans Affairs PTSD clinic.

Evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD) are efficacious; however, treatment dropout remains high. The delivery of intensive EBPs for PTSD (i.e., sessions three times per week or more) and telemental health may address barriers impacting dropout. Current evidence for intensive EBPs comes primarily from programs specifically designed for this level of care. Therefore, the feasibility of delivering intensive EBPs for PTSD in traditional outpatient clinics remains unclear. The aim of this pilot study was to identify veteran level of interest in intensive treatment and explore the feasibility of delivering intensive treatment via telemental health in an outpatient PTSD clinic at a Veterans Affairs (VA) hospital. One provider offered intensive treatment to 14 veterans. Three of the veterans initiated intensive treatment and completed with benefit. Veteranand system-level barriers, as well as veteran preferences for initiating intensive therapy and suggestions for implementing intensive EBPs in a routine outpatient clinic, are discussed.

Psychiatric medication prescriptions increasing for college students above and beyond the COVID-19 pandemic.

Psychiatric medication prescriptions for college students have been rising since 2007, with approximately 17% of college students prescribed medication for a mental health issue. This increase mirrors overall increases in both mental health diagnoses and treatment of university students. As psychiatric medication prescriptions for college students were increasing prior to pandemic, the goal of this study was to compare these prescriptions over the years, while accounting for the added stressor of the COVID-19 pandemic. This study utilized cross-sectional, retrospective data from a cohort of college students receiving care from the university's health service. We examined prescriptions for mental healthcare from 2015 to 2021. There was a significant increase in the percentage of psychiatric medication prescriptions in 2020 (baseline 15.8%; threshold 3.5%) and 2021 (baseline 41.3%; threshold 26.3%) compared to the historical baseline average for the whole sample and as well as for female students (2020 baseline 21.3% and threshold 4.6%; 2021 baseline 55.1% and threshold 33.7%). Within these years, we found higher trends for prescriptions in April-May as well as September-December. Overall, we found that psychiatric medication prescriptions have continued to rise through the years, with a large increase occurring during the pandemic. In addition, we found that these increases reflect the academic year, which is important for university health centers to consider when they are planning to staff clinics and plan the best way to treat college students with mental health difficulties in the future.

Reward circuit function in high BMI individuals with compulsive overeating: similarities with addiction.

CONTEXT: The rising rate of overweight and obese individuals among developing countries despite focused efforts on prevention and treatment underscores not only the need to better define the physiological factors that contribute to weight problems, but also the need to elucidate the neurobiological mechanisms of the self-regulatory failure over eating that leads to weight problems. Emergent findings suggest an overlapping model of addiction and compulsive overeating. OBJECTIVE: Our goal was to examine whether neural hyper-responsivity to reward typically associated with substance abuse could also be seen in individuals exhibiting binge-eating behavior. DESIGN: Participants completed self-assessments of demographic information and eating behavior. Neurofunctional data were collected via functional MRI (fMRI) scans while participants were exposed to personally relevant high-calorie cues. SETTING: The participants were recruited from the general community. PARTICIPANTS: Twenty-six individuals with high body mass index (BMI)>25 and moderate binge-eating behavior as assessed by the Binge Eating Scale (BES) were recruited for this study. MAIN OUTCOME MEASURES: fMRI BOLD response during exposure to high-calorie taste cues. RESULTS: The results showed that exposure to high-calorie taste cues elicited fMRI BOLD response in the reward system of individuals with high BMI, and, more importantly, that this hyper-responsivity increases with greater number of binge-eating symptoms (cluster-corrected p<.05, z=1.9). CONCLUSIONS: These findings support an overlapping neural model of addiction and self-regulatory failure over eating that may lead to problems with weight in humans. These findings offer insight into the prevention and treatment of disordered eating.

Marijuana craving in the brain.

Craving is one of the primary behavioral components of drug addiction, and cue-elicited craving is an especially powerful form of this construct. While cue-elicited craving and its underlying neurobiological mechanisms have been extensively studied with respect to alcohol and other drugs of abuse, the same cannot be said for marijuana. Cue-elicited craving for other drugs of abuse is associated with increased activity in a number of brain areas, particularly the reward pathway. This study used functional magnetic resonance imaging (fMRI) to examine cue-elicited craving for marijuana. Thirty-eight regular marijuana users abstained from use for 72 h and were presented with tactile marijuana-related and neutral cues while undergoing a fMRI scan. Several structures in the reward pathway, including the ventral tegmental area, thalamus, anterior cingulate, insula, and amygdala, demonstrated greater blood oxygen level dependent (BOLD) activation in response to the marijuana cue as compared with the neutral cue. These regions underlie motivated behavior and the attribution of incentive salience. Activation of the orbitofrontal cortex and nucleus accumbens was also positively correlated with problems related to marijuana use, such that greater BOLD activation was associated with greater number of items on a marijuana problem scale. Thus, cue-elicited craving for marijuana activates the reward neurocircuitry associated with the neuropathology of addiction, and the magnitude of activation of these structures is associated with severity of cannabis-related problems. These findings may inform the development of treatment strategies for cannabis dependence.

Reduced working memory performance in PTSD and suicide among veterans presenting for treatment.

Suicide is among the leading causes of death in the United States, underscoring the continued need to understand the mechanisms underlying suicide risk. A growing body of research has examined the role of working memory deficits in suicidal thoughts and behaviors (STBs), yet little research has evaluated putative pathways via which working memory impairments may heighten suicide risk. Elevated posttraumatic stress symptoms (PTSS) represent one plausible mechanism through which poor working memory performance may increase STBs. The present study utilized data from 140 treatment-seeking veterans who presented for an intake evaluation in the PTSD Clinical Team of a large VA Medical Center. Veterans completed self-report measures, a semi-structured PTSD evaluation, and a digit span working memory test. In addition to concurrent suicidal ideation assessed during the intake, additional information regarding past suicide attempts, presence of a safety plan, documentation of past suicidal behaviors, and engagement with suicide crisis lines were collected via electronic medical records. Consistent with hypotheses, a significant indirect path emerged such that poor working memory performance predicted greater suicidal ideation, greater likelihood of a past suicide attempt, and greater latent suicide risk via increased PTSS. However, no direct effect of working memory on STBs or indirect paths of PTSS on STBs via working memory emerged. These findings suggest that the relation between working memory and STBs may be explained by PTSS severity.

The impact of operational partnership on telemental health before, during, and after COVID-19.

The coronavirus disease (COVID-19) pandemic significantly accelerated the growth of telehealth services within the Veterans Health Administration (VHA), as the use of video conferencing to meet with Veterans in their homes increased tenfold in a 3-month period. A substantial portion of telehealth in VHA has traditionally comprised mental health services, and both the scope and volume of such services were significantly broadened in response to COVID-19 to allow for social distancing. The current article is a review of this mobilization from the framework of the People, Process, Technology, and Information model, with a particular highlight on the critical operational partnership between individual facilities providing care and the governing VHA program offices. Lessons learned and future goals for the sustainment and integration of telemental health services are also discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Meta-Analysis of the Treatment of Posttraumatic Stress Disorder in Adults With Comorbid Severe Mental Illness.

Objective: To evaluate the efficacy of psychosocial treatments for posttraumatic stress disorder (PTSD) among individuals with a comorbid severe mental illness (SMI; ie, schizophrenia, bipolar disorder, major depressive disorder).Data Sources: PubMed, PsycINFO, CINAHL, and Cochrane Library were searched from January 1998 to March 2020 using keywords related to PTSD, treatment, and severe mental illness.Study Selection: All clinical trials for PTSD psychotherapy among individuals with SMI were included. From 38 potentially eligible studies, a total of 14 clinical trials across 684 individuals with comorbid SMI and PTSD were identified and included in the analysis.Data Extraction: Data on demographic, SMI diagnosis, symptom severity, sample attrition, and treatment protocol received were extracted. Effect size calculations and subsequent meta-analyses were conducted using the Meta-Analysis Package for R (metafor) version 2.1-0 in R (3.6.0).Results: PTSD treatments had a large effect on PTSD outcomes among individuals with SMI, with patients experiencing a standard deviation reduction in PTSD symptomatology pre- to post-treatment (g = -1.009, P < .001, k = 34). Prolonged exposure (g = -1.464; P < .001; SE = 0.276; k = 5), eye movement desensitization and reprocessing (g = -1.351; P < .001; SE = 0.276; k = 5), and brief treatment program (g = -1.009; P < .001; SE = 0.284; k = 5) had the largest effects on PTSD symptoms.Conclusions: Although underrepresented in the PTSD literature, PTSD psychotherapies are effective for individuals with SMI. Treatments with an exposure-based component may have greater efficacy in this clinical population.

Lessons Learned in Implementing VA Video Connect for Evidence-Based Psychotherapies for Anxiety and Depression in the Veterans Healthcare Administration.

A top priority for the Veteran's Healthcare Administration is improving access to high-quality mental healthcare. Mobile and telemental healthcare are a vital component of increasing access for veterans. The Veteran's Healthcare Administration is making efforts to further broaden how veterans receive their care through VA Video Connect, which allows veterans to connect with their provider from their residence or workplace. In this mixed-methods study, successes and challenges associated with the rapid implementation of VA Video Connect telemental health appointments are examined through (1) administrative data and (2) qualitative interviews at one medical center. Within 1 year of the telehealth initiative, the number of providers experienced with telemental health increased from 15% to 85%, and telehealth appointments increased from 5376 to 14,210. Provider reported barriers included administrative challenges and concerns regarding care. Having an implementation model of telehealth champions and a team of experienced mental health providers allowed for rapid adoption of telehealth. Utilizing a similar model in other settings will further enable more veterans with depression and anxiety to have access to evidence-based psychotherapy, regardless of location or national crisis. With the dramatic increase in both training for providers as well as veteran use of telemental healthcare during the COVID-19 pandemic response, future research should aim to better understand which teams were able to switch to telehealth easily versus those which struggled, along with examining system-wide and provider-level factors that facilitated continued use of telehealth after social distancing requirements related to COVID-19 were relaxed.

The protective role of reasons for living on suicidal cognitions for military affiliated individuals with a positive PTSD screen in primary care settings.

BACKGROUND: Identifying and enhancing protective beliefs is essential in reducing suicide risk among military-affiliated individuals. The goal of this study was to examine if specific reasons for living impact the relationship between PTSD and suicidal cognitions among military-affiliated individuals in primary care settings. METHODS: Participants included 2,685 U.S. military personnel and their adult beneficiaries recruited from primary care clinics. Participants completed the Primary Care Posttraumatic Stress Disorder Screen, Suicide Cognitions Scale, and Brief Reasons for Living Inventory. RESULTS: Responsibility to family and survival and coping beliefs-were related to suicidal cognitions with higher levels associated with less suicidal cognitions and a weaker relationship between PTSD and suicidal cognitions. By contrast, fear of suicide and fear of social disapproval were associated with more suicidal cognitions, and the link between positive PTSD screen and suicidal cognitions was stronger for individuals with higher levels of fear of social disapproval. Moral objection did not predict suicidal cognitions and did not moderate the relationship between PTSD and suicidal cognitions. LIMITATIONS: The limitations of the study include that measures were done in primary care and brief screeners were often used. Additionally, the study is cross-sectional in nature, whereas some of the symptoms and outcome variables likely fluctuate over time. CONCLUSIONS: Findings suggest not all reasons for living are not equally influential and, among military-affiliated individuals with a positive PTSD screen, bolstering reasons for living related to responsibility to family and survival and coping skills could be particularly impactful in reducing suicide cognitions.

When chaos is the norm: How some veterans with PTSD are continuing to engage in trauma-focused treatments during the COVID-19 pandemic.

The COVID-19 pandemic has caused many Veterans Healthcare Administration providers working with veterans diagnosed with posttraumatic stress disorder to question the feasibility and appropriateness of continuing to provide trauma-focused treatment during this crisis. The Veterans Healthcare Administration is in a unique position to continue to provide trauma-informed care because of its capacity to offer telemental health services. Data from a Veterans Affairs medical center's posttraumatic stress disorder clinical team suggest that not only are veterans interested in continuing with treatment but also that the treatments can be modified to accommodate the current climate. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Evidence-based psychotherapy completion and symptom improvement among returning combat veterans with PTSD.

OBJECTIVE: Despite the availability of evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD) in the Veterans Health Administration, treatment completion rates are low and not all veterans benefit from these treatments. Understanding factors associated with PTSD EBP completion and symptom improvement is critical to improving completion rates and effectiveness. METHOD: This chart review study used the Andersen Behavioral Model to examine whether predisposing characteristics (nonmodifiable characteristics such as demographics), enabling factors (modifiable logistic variables that can facilitate or impede treatment use), and need factors (clinical characteristics such as symptom severity or comorbidities) predicted treatment completion or symptom improvement following PTSD EBP treatment among 82 Iraq and Afghanistan combat veterans. Logistic regression was used to examine treatment completion, and repeated measures analysis of variance was used to examine changes in PTSD and depression symptoms following treatment. RESULTS: EBP completers had greater improvement in PTSD symptoms than did EBP dropouts. Need factors (lack of comorbid substance use disorders and having problems with family members/significant others) were related to treatment completion, whereas enabling resources (receiving individual rather than group treatment) were related to symptom improvement. CONCLUSIONS: This is one the first studies to use a comprehensive model to examine factors relevant to treatment completion and symptom improvement. Results suggest that nonmodifiable predisposing characteristics do not drive treatment completion and symptom improvement, underscoring the potential importance of targeting enabling resources and needs factors for intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial.

BACKGROUND: Posttraumatic stress disorder (PTSD) rarely remits over time, and if left untreated, leads to significant distress, functional impairment, and increased health care costs. Fortunately, effective evidence-based treatments (EBTs) for PTSD, such as Prolonged Exposure (PE), exist. Despite their availability and efficacy, a significant number of individuals with PTSD do not initiate treatment when offered or dropout prematurely. One proposed theory suggests that the emotional-numbing symptoms of PTSD (e.g., blunted affect, apathy) can serve as a barrier to engaging in, and successfully completing, treatment; and the broad human-animal interaction (HAI) literature available suggests that HAI can potentially reduce emotional numbing related to PTSD. Accordingly, this manuscript describes an ongoing, federally funded, randomized controlled trial testing the efficacy of RESCUE, an HAI intervention, as a viable adjunctive treatment component for PE. METHODS/DESIGN: The study will include 70 veterans with PTSD treated at a Southeastern Veterans Affairs Medical Center (VAMC). All participants in the trial receive up to 12 sessions of PE. Participants are randomly assigned 1:1 to (1) volunteer at a local animal shelter or (2) volunteer at a community agency of their choice as part of their in-vivo exposure exercises for PE. Outcomes will be examined via standard clinical interviews, self-report questionnaires, and thematic interviews. DISCUSSION: It is hypothesized that participants in the HAI condition will report greater decreases in emotional-numbing symptoms and increased treatment compliance and completion rates relative to those in the community volunteer condition. If successful, RESCUE, could be easily incorporated into standard PE and broadly disseminated. TRIAL REGISTRATION: ClinicalTrials.gov. ID: NCT03504722. Retrospectively registered on 2 May 2017.