A substantial number of trauma-exposed veterans seen in primary care report significant symptoms of PTSD and depression. While primary care mental health integration (PCMHI) providers have been ...successful in delivering brief mental health treatments in primary care, few studies have evaluated interventions that combine mobile health resources with PCMHI groups. This pilot study assessed the potential benefits of webSTAIR, a 10-module transdiagnostic treatment for trauma-exposed individuals, supported by 5 biweekly group sessions delivered via telehealth. The transdiagnostic and mobile health nature of the treatment, as well as the therapist and peer support provided through group sessions, may offer an innovative approach to increasing access to patient-centered and trauma-informed treatment in primary care settings.
Thirty-nine male and female veterans with trauma-related symptoms (i.e., PTSD and/or depression) participated in group webSTAIR. Mixed effects analyses were conducted to assess changes in PTSD and depression at pre-, mid-, and post-treatment. Baseline symptom severity was assessed as a predictor of module completion and group attendance. The project was part of a VHA quality improvement project, and IRB approval was waived by the affiliated university.
Analyses revealed significant pre-to-post improvement in both PTSD and depression outcomes with a large effect size for PTSD (Hedges' gav = 0.88) and medium to large for depression (Hedges' gav = 0.73). Of participants who completed the baseline assessment, 90% began webSTAIR; of those, 71% completed the program. Baseline symptoms of PTSD and depression did not predict group attendance or module completion.
Good outcomes and a satisfactory retention rate suggest that group webSTAIR may provide easily accessible, high-quality, and effective treatment for patients presenting with trauma-related problems without increasing therapist or system burdens. The results suggest the value of conducting a randomized controlled trial to test the effectiveness of group webSTAIR relative to PCMHI usual care or other evidence-based, disorder-specific (e.g., PTSD) treatments for trauma-exposed individuals in PCMHI.
Salt-sensitive hypertension (SSH) is characterized by impaired sodium excretion and subnormal vasodilatory response to salt loading. Sacubitril/valsartan (LCZ696) was hypothesized to increase ...natriuresis and diuresis and result in superior blood pressure control compared with valsartan in Asian patients with SSH. In this randomized, double-blind, crossover study, 72 patients with SSH received sacubitril/valsartan 400 mg and valsartan 320 mg once daily for 4 weeks each. SSH was diagnosed if the mean arterial pressure increased by ≥10% when patients switched from low (50 mmol/d) to high (320 mmol/d) sodium diet. The primary outcome was cumulative 6- and 24-hour sodium excretion after first dose administration. Compared with valsartan, sacubitril/valsartan was associated with a significant increase in natriuresis (adjusted treatment difference: 24.5 mmol/6 hours, 50.3 mmol/24 hours, both P<0.001) and diuresis (adjusted treatment difference: 291.2 mL/6 hours, P<0.001; 356.4 mL/24 hours, P=0.002) on day 1, but not on day 28, and greater reductions in office and ambulatory blood pressure on day 28. Despite morning dosing of both drugs, ambulatory blood pressure reductions were more pronounced at nighttime than at daytime or the 24-hour average. Compared with valsartan, sacubitril/valsartan significantly reduced N-terminal pro B-type natriuretic peptide levels on day 28 (adjusted treatment difference: -20%; P=0.001). Sacubitril/valsartan and valsartan were safe and well tolerated with no significant changes in body weight or serum sodium and potassium levels with either treatments. In conclusion, sacubitril/valsartan compared with valsartan was associated with short-term increases in natriuresis and diuresis, superior office and ambulatory blood pressure control, and significantly reduced N-terminal pro B-type natriuretic peptide levels in Asian patients with SSH.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01681576.
There were two quality improvement aims in this project: (1) to evaluate the outcomes of a six-week closed geriatric focused Acceptance and Commitment Therapy (ACT)-based group called "Aging ...Resiliently" offered in a primary care setting, and (2) to obtain feedback from group members in order to make relevant modifications to future groups.
Four cohorts of veterans ages 58 and older participated in the group (N = 17). Paired samples t-tests were computed to determine the significance of changes on pre- and post- self-report measures of depression, experiential avoidance, and life satisfaction. Veterans also provided feedback in the form of an open-ended feedback questionnaire.
There were statistically significant improvements in depressive symptoms and satisfaction with life, but not in experiential avoidance. Two major themes emerged from the feedback questionnaire about what group members found to be the most helpful: (1) self-reflection/values, and (2) the social process of the group.
At our institution, the Aging Resiliently group yielded meaningful outcomes for older veterans presenting with different problems related to aging.
This Aging Resiliently group proved to be a potential effective, feasible, and acceptable psychotherapy for older veterans in our established local primary care setting.
Self-compassion, mindfulness, and psychological inflexibility, constructs associated with mindfulness-based interventions, have demonstrated associations with multiple aspects of psychological ...health. However, a very limited body of research has analyzed the relative predictive strength among mindfulness-related constructs. Regression analyses were performed to determine the common and unique variance in psychological health predicted by these constructs and to compare their relative predictive strength in a nonclinical sample of 147 undergraduate students at a Mid-Atlantic university. Consistent with previous research, self-compassion demonstrated a stronger ability than single-factor mindfulness to predict variance in psychological health. However, results were mixed when a multifaceted measure of mindfulness was considered. Self-compassion predicted greater variance than multifaceted mindfulness when prediction was based on one total score, but not when individual subscales were analyzed. Psychological inflexibility predicted greater variance than did self-compassion for negative indicators of psychological health. Results suggest that self-compassion and psychological inflexibility may demonstrate greater associations with psychological health than single scores of mindfulness and that important predictive power is lost, particularly from the nonreactivity facet, when multifaceted mindfulness is consolidated into a single score.
Positive health behaviors can promote brain health with age. We developed a novel health education and implementation group for older Veterans called the “Healthy Aging Project: Brain” also known as ...HAP‐B. We had these primary goals: provide psychoeducation, focus on ‘what matters’, improve awareness of health behaviors, and promote behavioral change through individualized goal‐setting, monitoring, and support. The scientific literature + needs assessment‐based content addresses 4 key areas: physical activity, sleep improvement, cognitive stimulation, and social interaction. Each of the 6 “classes” are 90 minutes long. Pre‐pandemic n=37 Veterans across 6 groups participated. To mitigate health risk exposure and reach Veterans for whom travel is a barrier, we have adapted the group to a virtual format with n=18 participants across 3 virtual groups (another group is ongoing, n=6). This QA/QI project collects optional pre/post self‐report measures which target satisfaction with the group, depressive symptoms, sleep quality, social support, and subjective well‐being. Additions along the way include in‐session self‐ratings for targeted goal behavior adherence and a pre/post self‐efficacy questionnaire. Our population tends to be predominantly male and White. Results and qualitative findings are promising. The group has successfully been run in 3 outpatient in‐person settings: Mental Health Services, Geriatrics Memory Health Clinic, and Primary Care Mental Health Integration. In‐person results suggest a significant decline in report of depressive symptoms. Lessons learned for implementation for both the in‐person and virtual formats will be shared, as well as analyses on associations between self‐efficacy and satisfaction with life over time. Future directions include ongoing data collection to increase power, continued efforts to increase participant diversity, and direct comparison of in‐person vs virtual formats. We will also present our initiated adaptation for flexible use in long‐term care facilities and among those with cognitive impairments.
Sensitive, reliable, and scalable biomarkers are needed to accelerate the development of therapies for Parkinson disease (PD). In this study, we evaluate the biomarkers of early PD diagnosis, disease ...progression, and treatment effect collected in the SPARK.
Cinpanemab is a human-derived monoclonal antibody binding preferentially to aggregated forms of extracellular α-synuclein. SPARK was a randomized, double-blind, placebo-controlled, phase 2 multicenter trial evaluating 3 cinpanemab doses administered intravenously every 4 weeks for 52 weeks with an active treatment dose-blind extension period for up to 112 weeks. SPARK enrolled 357 participants diagnosed with PD within 3 years, aged 40-80 years, ≤2.5 on the modified Hoehn and Yahr scale, and with evidence of striatal dopaminergic deficit. The primary outcome was change from baseline in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale total score. Secondary and exploratory biomarker outcomes evaluated change from baseline at week 52 relative to placebo. Dopamine transporter SPECT and MRI were used to quantify changes in the nigrostriatal dopamine pathway and regional atrophy. CSF and plasma samples were used to assess change in total α-synuclein levels, α-synuclein seeding, and neurofilament light chain levels. SPARK was conducted from January 2018 to April 2021 and terminated due to lack of efficacy.
Approximately 3.8% (15/398) of SPECT-imaged participants did not have evidence of dopaminergic deficit and were screen-failed. Binary classification of α-synuclein seeding designated 93% (110/118) of the enrolled CSF subgroup as positive for α-synuclein seeds at baseline. Clinical disease progression was observed, with no statistically significant difference in cinpanemab groups compared with that in placebo. Ninety-nine percent of participants with positive α-synuclein seeding remained positive through week 52. No statistically significant changes from baseline were observed between treatment groups and placebo across biomarker measures. Broadly, there was minimal annual change with high interindividual variability across biomarkers-with striatal binding ratios of the ipsilateral putamen showing the greatest mean change/SD over time.
Biomarker results indicated enrollment of the intended population with early PD, but there was no significant correlation with disease progression or clear evidence of a cinpanemab treatment effect on biomarker measures. Suitable biomarkers for evaluating disease severity and progression in early PD trials are still needed.
NCT03318523 (clinicaltrials.gov/ct2/show/NCT03318523); Submitted October 24, 2017; First patient enrolled January 2018.
Background The debilitating effects of chronic glucocorticoids excess are well-known, but comparatively little is understood about the role of acute cortisol. Indirect evidence in rodents suggests ...that acute cortisone could selectively increase some forms of long-duration aversive states, such as “anxiety,” but not relatively similar, briefer aversive states, such as “fear.” However, no prior experimental studies in humans consider the unique effects of cortisol on anxiety and fear, using well-validated methods for eliciting these two similar but dissociable aversive states. The current study examines these effects, as instantiated with short- and long-duration threats. Methods Healthy volunteers ( n = 18) received placebo or a low (20 mg) or a high (60 mg) dose of hydrocortisone in a double-blind crossover design. Subjects were exposed repeatedly to three 150-sec duration conditions: no shock; predictable shocks, in which shocks were signaled by a short-duration threat cue; and unpredictable shocks. Aversive states were indexed by acoustic startle. Fear was operationally defined as the increase in startle reactivity during the threat cue in the predictable condition (fear-potentiated startle). Anxiety was operationally defined as the increase in baseline startle from the no shock to the two threat conditions (anxiety-potentiated startle). Results Hydrocortisone affected neither baseline nor short-duration, fear-potentiated startle but increased long-duration anxiety-potentiated startle. Conclusions These results suggest that hydrocortisone administration in humans selectively increases anxiety but not fear. Possible mechanisms implicated are discussed in light of prior data in rodents. Specifically, hydrocortisone might increase anxiety via sensitization of corticotrophin-releasing hormones in the bed nucleus of the stria terminalis.
The present study examined psychometric and experiential differences between paper-and-pencil and electronic versions of the Suicide Status Form (SSF), a measure used as part of the Collaborative ...Assessment and Management of Suicidality. Thirty-five graduate students and professionals in social work, clinical psychology, or counseling role-played a suicidal client in two consecutive intake sessions with SSF-trained therapists, one session with a paper version of the SSF and the other using a computer, in counterbalanced order. Statistical equivalence analyses revealed that SSF ratings did not differ significantly between modalities except on two scales. Agitation was higher on the computer-based SSF for those who completed the computer version first. Additionally, participants rated their wish to live significantly higher on paper than computer. These findings are important because agitation is a significant warning sign of suicidal behavior, and the wish to live rating is part of an index score used to reliably classify different suicidal states, with implications for future suicidal behaviors. Measures of working alliance, psychotherapy expectations, affective experience, and session experience were completed after each session and at the end. Clients’ ratings significantly favored the paper SSF on 4 of these 15 experiential variables, but only when clients rated both versions at the end of the study. This measurement is an artifact of the within-subjects research design, and so findings might not generalize to clinical practice. Overall, despite predominant equivalence of the versions, there were important findings favoring the paper SSF. CAMS clinicians using the SSF need to know about these subtle differences between versions, and SSF training should take these findings into account. Additionally, a literature review is included on technology-based psychotherapy addressing the therapeutic alliance and its association with treatment outcome within face-to-face psychotherapy with adjunctive technology, videoconferencing-based psychotherapy, telephone-based psychotherapy, and internet-based psychotherapy with text communication. Results indicate equivalent alliance strength for tasks and goals, but mixed findings for bond; thus, aspects of the alliance may be differentially affected. Results are also mixed concerning the strength of the alliance-outcome relation. Conclusions are tentative due to methodological limitations and a lack of standardized measures, and research directions are suggested.
The main challenge for gaining biological insights from genetic associations is identifying which genes and pathways explain the associations. Here we present DEPICT, an integrative tool that employs ...predicted gene functions to systematically prioritize the most likely causal genes at associated loci, highlight enriched pathways and identify tissues/cell types where genes from associated loci are highly expressed. DEPICT is not limited to genes with established functions and prioritizes relevant gene sets for many phenotypes.
Introduction Burnout poses a substantial, ongoing threat to healthcare worker (HCW) wellbeing and to the delivery of safe, quality healthcare. While systemic and organization-level changes in ...healthcare are critically important, HCWs also need individual-level skills to promote resilience. The objective of this trial is to test feasibility, acceptability, and efficacy of PARK, an online self-guided positive affect regulation intervention, in a sample of healthcare workers during the COVID-19 pandemic. Design and methods In the context of the unprecedented rise in burnout during the COVID-19 pandemic, we conducted a randomized waitlist-controlled trial of the Positive Affect Regulation sKills (PARK) program—a five-week, online, self-guided coping skills intervention nested within an ongoing cohort of HCWs. N = 554 healthcare workers were randomly assigned to receive the intervention immediately or to receive the intervention after approximately 12 weeks. Outcomes included change in burnout, emotional wellbeing (positive affect, meaning and purpose, depression, anxiety) and sleep over approximately 12 weeks. Analyses included mixed-effects linear regression models comparing change over time in outcomes between intervention and control conditions. Results One third (n = 554) of the participants in the cohort of HCWs consented to participate and enrolled in PARK in April 2022. Compared to those who did not enroll, participants in the trial reported higher burnout, poorer emotional wellbeing, and poorer sleep at baseline (April, 2022; all p s < .05). Intent-to-treat analyses showed that participants randomly assigned to the intervention immediately (PARK-Now) improved significantly on anxiety (within-group change on PROMIS T-score = -0.63; p = .003) whereas those in the waitlist (PARK-Later) did not (within group T-score change 0.04, p = 0.90). The between-group difference in change, however, was not statistically significant ( B = -0.67 p = 0.10). None of the other wellbeing outcomes changed significantly in the intervention group compared to the waitlist. Additional as-treated analyses indicated that those participants who completed all 5 of the weekly online lessons (N = 52; 9.4%) improved significantly more on the primary outcome of positive affect compared to those who enrolled in PARK but completed zero lessons (n = 237; 42.8%; B = 2.85; p = .0001). Conclusions Online self-guided coping skills interventions like PARK can be effective in targeted samples and future work will focus on adaptations to increase engagement and tailor PARK for HCWs who could most benefit.
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