A Randomized Controlled Trial of OC-Go for Childhood Obsessive-Compulsive Disorder: Augmenting Homework Compliance in Exposure With Response Prevention Treatment.

The current study investigates a novel digital tool designed to address barriers to out-of-session homework adherence in exposure with response prevention (ERP) for child obsessive-compulsive disorder (OCD). The OC-Go platform allows clinicians to create and push tailored interactive protocol- or symptom-specific assignments to patients on their mobile devices, providing in-the-moment step-by-step directions, encouragement, accountability, and a sense of therapeutic presence for patients during out-of-office exposures. The platform also facilitates objective measurement of homework and allows providers to support one another through a shared and searchable crowdsourced library with hundreds of assignable exposures and psychoeducation activities for specific OCD symptoms. The current study tested the usability and feasibility of the OC-Go platform with ERP stakeholders (OCD therapists, patients, and parents; N = 172) using the System Usability Scale (SUS). The study also tested the efficacy of OC-Go for augmenting homework adherence and clinical response using a randomized controlled, crossover design in a sample of 28 treatment-seeking youth with OCD. Participants randomized to standard ERP exhibited a homework adherence rate of 68.4% (95% CI [65.6, 71.0]), those randomized to ERP with OC-Go exhibited a greater adherence rate of 83.3% (95% CI [80.8, 85.6], p < .001). Both groups experienced large declines in Children's Yale-Brown Obsessive-Compulsive Scale-rated OCD (d = 1.31, p < .001), though participants randomized to begin ERP with OC-Go exhibited clinically significant greater improvement (p = .05), translating into an additional augmented treatment response at the Week 6 primary end point (d = 0.36) and the Week 12 treatment end point (d = 0.72). Stakeholders rated OC-Go in the 90th percentile for usability on the SUS, indicative of a highly usable and easy-to-learn technology. Initial evidence supports OC-Go as a feasible and effective adjunct to improve out-of-office exposure measurement, adherence, and treatment response in ERP for child OCD.

Massed v. standard prolonged exposure therapy for PTSD in military personnel and veterans: 12-month follow-up of a non-inferiority randomised controlled trial.

BACKGROUND: The utilisation of massed therapy for treating posttraumatic stress disorder (PTSD) is gaining strength, especially prolonged exposure. However, it is unknown whether massed prolonged exposure (MPE) is non-inferior to standard prolonged exposure (SPE) protocols in the long term. The current study aimed to assess whether MPE was non-inferior to SPE at 12 months post-treatment, and to ascertain changes in secondary measure outcomes. METHODS: A multi-site non-inferiority randomised controlled trial (RCT) compared SPE with MPE in 12 clinics. The primary outcome was PTSD symptom severity (CAPS-5) at 12 months post-treatment commencement. Secondary outcome measures included symptoms of depression, anxiety, anger, disability, and quality of life at 12 weeks and 12 months post-treatment commencement. Outcome assessors were blinded to treatment allocation. The intention-to-treat sample included 138 Australian military members and veterans and data were analysed for 134 participants (SPE = 71, MPE = 63). RESULTS: Reductions in PTSD severity were maintained at 12 months and MPE remained non-inferior to SPE. Both treatment groups experienced a reduction in depression, anxiety, anger, and improvements in quality of life at 12 weeks and 12 months post-treatment commencement. Treatment effects for self-reported disability in the SPE group at 12 weeks were not maintained, with neither group registering significant effects at 12 months. CONCLUSIONS: The emergence of massed protocols for PTSD is an important advancement. The current study provides RCT evidence for the longevity of MPE treatment gains at 12 months post-treatment commencement and demonstrated non-inferiority to SPE. Promisingly, both treatments also significantly reduced the severity of comorbid symptoms commonly occurring alongside PTSD.

Individual symptom reduction and post-treatment severity: Varying levels of symptom amelioration in response to prolonged exposure for post-traumatic stress disorder.

Many patients evince significant post-traumatic stress disorder (PTSD) symptoms after a dose of an evidence-based treatment (EBT) for PTSD. Little research systematically addresses if individual PTSD symptoms are more or less resistant to change through an EBT for PTSD or have greater or lesser post-treatment severity levels. Two studies within VA medical centers provided data. Study 1 (n = 81) was drawn from a randomized clinical trial of Prolonged Exposure (PE), an EBT for PTSD. Study 2 (n = 225) was drawn from two PTSD specialty clinics employing PE. Symptoms were assessed pre- and post-treatments via semi-structured clinician interview (Study 1) and patient self-report (Studies 1 and 2). Most individual symptoms reduced about the same amount through the course of treatment except for avoidance, which showed greater reductions. High heterogeneity in post-treatment symptom severity was found with troubled sleep and hypervigilance displaying above average levels, and traumatic amnesia, foreshortened future, and flashbacks displaying below average levels. Method of symptom measurement had a modest impact on results, as semi-structured clinical interview results were moderately more differentiated than self-report measures. Results were generally consistent between an efficacy (i.e., extremely high, potentially artificial methodological control) and effectiveness (i.e., relatively more real world) context. Primary limitation is analysis of single items on semi-structured clinician interview and patient self-report scale when psychometric validation studies did not interpret measures this way. Moreover, DSM-IV criteria for PTSD were assessed. EBT augmentation and new treatment development should focus on further reducing both PTSD symptoms in general and on the specific symptoms of troubled sleep and hypervigilance, which persist to a greater degree. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Effect of massed v. standard prolonged exposure therapy on PTSD in military personnel and veterans: a non-inferiority randomised controlled trial.

BACKGROUND: A short, effective therapy for posttraumatic stress disorder (PTSD) could decrease barriers to implementation and uptake, reduce dropout, and ameliorate distressing symptoms in military personnel and veterans. This non-inferiority RCT evaluated the efficacy of 2-week massed prolonged exposure (MPE) therapy compared to standard 10-week prolonged exposure (SPE), the current gold standard treatment, in reducing PTSD severity in both active serving and veterans in a real-world health service system. METHODS: This single-blinded multi-site non-inferiority RCT took place in 12 health clinics across Australia. The primary outcome was PTSD symptom severity measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 12 weeks. 138 military personnel and veterans with PTSD were randomised. 71 participants were allocated to SPE, with 63 allocated to MPE. RESULTS: The intention-to-treat sample included 138 participants, data were analysed for 134 participants (88.1% male, M = 46 years). The difference between the mean MPE and SPE group PTSD scores from baseline to 12 weeks-post therapy was 0.94 [95% confidence interval (CI) -4.19 to +6.07]. The upper endpoint of the 95% CI was below +7, indicating MPE was non-inferior to SPE. Significant rates of loss of PTSD diagnosis were found for both groups (MPE 53.8%, SPE 54.1%). Dropout rates were 4.8% (MPE) and 16.9% (SPE). CONCLUSIONS: MPE was non-inferior to SPE in significantly reducing symptoms of PTSD. Significant reductions in symptom severity, low dropout rates, and loss of diagnosis indicate MPE is a feasible, accessible, and effective treatment. Findings demonstrate novel methods to deliver gold-standard treatments for PTSD should be routinely considered.

The influence of posttraumatic stress disorder treatment on anxiety sensitivity: Impact of prolonged exposure, sertraline, and their combination.

Trauma-informed beliefs often decrease during posttraumatic stress disorder (PTSD) treatment. This may also extend to anxiety sensitivity (AS), defined as a fear of anxiety-related sensations and beliefs that anxiety is dangerous and/or intolerable. However, little is known about how AS changes during exposure-based and psychopharmacological PTSD treatments. Further, high AS may be a risk factor for diminished PTSD symptom improvement and increased treatment dropout. To better understand how AS impacts and is impacted by PTSD treatment, we conducted a secondary analysis of a randomized clinical trial with a sample of 223 veterans (87.0% male, 57.5% White) with PTSD from four U.S. sites. Veterans were randomized to receive prolonged exposure (PE) plus placebo (n = 74), sertraline plus enhanced medication management (n = 74), or PE plus sertraline (n = 75). Veterans answered questions about PTSD symptoms and AS at baseline and 6-, 12-, 24-, 36-, and 52-week follow-ups. High baseline AS was related to high levels of PTSD severity at 24 weeks across all conditions, ß = .244, p = .013, but did not predict dropout from exposure-based, ß = .077, p = .374, or psychopharmacological therapy, ß = .009, p = .893. AS also significantly decreased across all three treatment arms, with no between-group differences; these reductions were maintained at the 52-week follow-up. These findings suggest that high AS is a risk factor for attenuated PTSD treatment response but also provide evidence that AS can be improved by both PE and an enhanced psychopharmacological intervention for PTSD.

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel.

OBJECTIVE: Prolonged exposure (PE) therapy is a first-line posttraumatic stress disorder (PTSD) treatment, but the manualized 90-min session format constitutes a barrier to adopting PE in most settings because they use 60-min sessions for scheduling and billing. We examined whether 60-min PE sessions were as effective and efficient as 90-min PE sessions. METHOD: In total, 160 active-duty military personnel with PTSD were randomized to 8-15 sessions of 60- or 90-min PE sessions and assessed pre- and posttreatment, and 3- and 6-month posttreatment, using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual for Mental Disorders, 5th edition [DSM-5] (CAPS-5). Participants were also assessed weekly during treatment using the PTSD Checklist for DSM-5 (PCL-5). A 60-min PE was hypothesized to be noninferior to 90-min PE based on preliminary studies. RESULTS: Using intent-to-treat analyses, the 95% CI for the difference between 60- and 90-min PE was less than the noninferiority margin (4.69 for the CAPS-5 and 7.38 for the PCL-5) at all three endpoints, suggesting that the efficacy of 60-min PE was noninferior to that of 90-min PE. Similarly, the rate of improvement per session for 60-min PE was noninferior to the rate for 90-min sessions for the PCL-5. Sensitivity analyses and Bayes factors were consistent with these results. CONCLUSIONS: 60-min sessions of PE are noninferior to 90-min sessions with regard to both efficacy and efficiency. Thus, PE can be effectively delivered in shorter sessions, making it easier for behavioral health providers to implement within the military health system and in other mental health systems that use 60-min session appointments. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Change in posttraumatic stress disorder-related thoughts during treatment: Do thoughts drive change when pills are involved?

Posttraumatic negative thoughts about one's self and the world are related to posttraumatic stress disorder (PTSD) symptom severity and change in cognitive behavioral treatment (CBT), but little is known about this association when CBT is delivered with medication. The current study presents a planned comparison of changes in negative posttraumatic thoughts during (a) prolonged exposure (PE) plus pill placebo (PE+PLB), (b) sertraline plus enhanced medication management (SERT+EMM), and (c) PE plus sertraline (PE+SERT) as part of a randomized clinical trial in a sample of 176 veterans. Lagged regression modeling revealed that change in posttraumatic negative thoughts was associated with PTSD symptom change in the conditions in which participants received sertraline, ds = 0.14-0.25, ps = 0.04-.001). However, contrary to previous research, the models that started with symptom change were also statistically significant, d = 0.23, p < .001, for the lagged effect of symptoms on negative thoughts about self in the SERT+EMM condition, indicating a bidirectional association between such thoughts and PTSD symptoms. In the PE+PLB condition, no significant association between posttraumatic thoughts and PTSD symptoms emerged in either direction. These results suggest that the previously demonstrated role of change in posttraumatic thoughts leading to PTSD symptom reduction in PE may be altered when combined with pill administration, either active or placebo.

Increased Smoking Cessation Among Veterans With Large Decreases in Posttraumatic Stress Disorder Severity.

INTRODUCTION: Improvement in posttraumatic stress disorder (PTSD) is associated with better health behavior such as better medication adherence and greater use of nutrition and weight loss programs. However, it is not known if reducing PTSD severity is associated with smoking cessation, a poor health behavior common in patients with PTSD. AIMS AND METHODS: Veterans Health Affairs (VHA) medical record data (2008-2015) were used to identify patients with PTSD diagnosed in specialty care. Clinically meaningful PTSD improvement was defined as ≥20 point PTSD Checklist (PCL) decrease from the first PCL ≥50 and the last available PCL within 12 months and at least 8 weeks later. The association between clinically meaningful PTSD improvement and smoking cessation within 2 years after baseline among 449 smokers was estimated in Cox proportional hazard models. Entropy balancing controlled for confounding. RESULTS: On average, patients were 39.4 (SD = 12.9) years of age, 86.6% were male and 71.5% were white. We observed clinically meaningful PTSD improvement in 19.8% of participants. Overall, 19.4% quit smoking in year 1 and 16.6% in year 2. More patients with versus without clinically meaningful PTSD improvement stopped smoking (n = 36, cumulative incidence = 40.5% vs. 111, cumulative incidence = 30.8%, respectively). After controlling for confounding, patients with versus without clinically meaningful PTSD improvement were more likely to stop smoking within 2 years (hazard ratio = 1.57; 95% confidence interval: 1.04-2.36). CONCLUSIONS: Patients with clinically meaningful PTSD improvement were significantly more likely to stop smoking. Further research should determine if targeted interventions are needed or whether improvement in PTSD symptoms is sufficient to enable smoking cessation. IMPLICATIONS: Patients with PTSD are more likely to develop chronic health conditions such as heart disease and diabetes. Poor health behaviors, including smoking, partly explain the risk for chronic disease in this patient population. Our results demonstrate that clinically meaningful PTSD improvement is followed by greater likelihood of smoking cessation. Thus, PTSD treatment may enable healthier behaviors and reduce risk for smoking-related disease.

Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games: A Randomized Trial.

Disseminating efficacious psychological treatments remains a challenge for researchers and clinicians. In the case of social anxiety disorder (SAD), Social Effectiveness Therapy for Children (SET-C) has been demonstrated as an efficacious intervention, but elements of the protocol, such as peer generalization sessions, remain challenging to conduct in typical clinical settings. To address this need, we developed an artificially intelligent, web-based application, Pegasys-VR™, designed to replace peer generalization sessions and enhance homework compliance. The feasibility of Pegasys-VR™ was tested in a randomized controlled trial in comparison to SET-C. The results indicated that both programs were equally efficacious in decreasing anxiety and improving social skill in social encounters. Sixty-three percent (63%) of children treated with SET-C and 60% treated with Pegasys-VR™ did not meet diagnostic criteria for SAD at posttreatment. Pegasys-VR™ is a feasible, efficacious, and dissemination-friendly element of a comprehensive treatment program for social anxiety disorder in children.

Predictors of Response to Prolonged Exposure, Sertraline, and Their Combination for the Treatment of Military PTSD.

Objective: The current study is an analysis of predictors of posttraumatic stress disorder (PTSD) treatment response in a clinical trial comparing (1) prolonged exposure plus placebo (PE + PLB), (2) PE + sertraline (PE + SERT), and (3) sertraline + enhanced medication management (SERT + EMM) with predictors including time since trauma (TST), self-report of pain, alcohol use, baseline symptoms, and demographics.Methods: Participants (N = 196) were veterans with combat-related PTSD (DSM-IV-TR) of at least 3 months' duration recruited between 2012 and 2016 from 4 sites in the 24-week PROlonGed ExpoSure and Sertraline (PROGrESS) clinical trial (assessments at weeks 0 [intake], 6, 12, 24, 36, and 52).Results: Across treatment conditions, (1) longer TST was predictive of greater week 24 PTSD symptom improvement (ß = 1.72, P = .01) after adjusting for baseline, (2) higher baseline pain severity was predictive of smaller symptom improvement (ß = -2.96, P = .003), and (3) Hispanic patients showed greater improvement than non-Hispanic patients (ß = 12.33, P = .03). No other baseline characteristics, including alcohol consumption, were significantly predictive of week 24 improvement. Comparison of TST by treatment condition revealed a significant relationship only in those randomized to the PE + SERT condition (ß = 2.53, P = .03). Longitudinal analyses showed similar results.Conclusions: The finding that longer TST shows larger symptom reductions is promising for PTSD patients who might not seek help for years following trauma. Higher baseline pain severity robustly predicted attenuated and slower response to all treatment conditions, suggesting a common neuropathologic substrate. Finally, in the current study, alcohol use did not impede the effectiveness of pharmacotherapy for PTSD.Trial Registration: ClinicalTrials.gov identifier: NCT01524133.