Beyond the Constraints of an RCT: Naturalistic Treatment Outcomes for Anxiety-Related Disorders.
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ABSTRACT:
SUBMITTER: Asnaani A
PROVIDER: S-EPMC8246650 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAnxiety disorders share common vulnerabilities and symptoms. Disorder-specific treatment is efficacious, but few access evidence-based care. Administering transdiagnostic cognitive-behavioral therapy via the internet (iCBT) may increase access to evidence-based treatment, with a recent randomized controlled trial (RCT) providing preliminary support for this approach. This study extends those findings and aims to answer three questions: Is a transdiagnostic iCBT program for anxiety disorders efficacious and acceptable? Does it result in change for specific disorders? Can good clinical outcomes be obtained when guidance is provided via a Coach rather than a Clinician?MethodRCT (N?=?131) comparing three groups: Clinician-supported (CL) vs. Coach-supported (CO) vs. waitlist control (Control). Individuals met DSM-IV criteria for a principal diagnosis of generalized anxiety disorder (GAD), social phobia (SP) or panic disorder with or without agoraphobia (Pan/Ag). Treatment consisted of an 8-lesson/10 week iCBT program with weekly contact from a Clinician or Coach, and follow-up at 3-months post-treatment.ResultsOutcomes for the pooled treatment groups (CL+CO) were superior to the Control group on measures of anxiety, depression and disability, were associated with medium to large effect sizes (Cohen's d?=?.76-1.44) (response rate?=?89-100%), and were maintained at follow-up. Significant reductions were found on disorder-specific outcomes for each of the target diagnoses, and were associated with large effect sizes. CO participants achieved similar outcomes to CL participants at post-treatment, yet had significantly lower symptom severity scores on general anxiety, panic-disorder, depression and disability at follow-up (d?=?.45-.46). Seventy-four percent of CO and 76% of CL participants completed the program. Less than 70 minutes of Clinician or Coach time was required per participant during the program.DiscussionThis transdiagnostic iCBT course for anxiety appears to be efficacious, associated with significant change for three target disorders, and is efficacious when guided by either a Clinician or Coach.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000242022.
| S-EPMC3223218 | biostudies-literature
Project description:Multiple and diverse psychotherapeutic or psychopharmacologic treatments effectively reduce symptoms for many patients with anxiety disorders, but the trajectory and magnitude of response vary considerably. This heterogeneity of treatment response has invigorated the search for biomarkers of treatment response in anxiety disorders, across the lifespan. In this review, we summarize evidence for biomarkers of treatment response in children, adolescents and adults with generalized, separation and social anxiety disorders as well as panic disorder. We then discuss the relationship between these biomarkers of treatment response and the pathophysiology of anxiety disorders. Finally, we provide context for treatment response biomarkers of the future, including neuronally-derived extracellular vesicles in anxiety disorders and discuss challenges that must be overcome prior to the debut of treatment response biomarkers in the clinic. A number of promising treatment response biomarkers have been identified, although there is an urgent need to replicate findings and to identify which biomarkers might guide clinicians in selecting from available treatments rather than just simply identifying patients who may be less likely to respond to a given intervention.
| S-EPMC7508464 | biostudies-literature
Project description:To examine the effectiveness of genetic testing in a real-world setting and to assess its impact on clinician treatment decisions. This was a naturalistic, unblinded, prospective analysis of psychiatric patients and clinicians who utilized a commercially available genetic test (between April and October of 2013), which incorporates 10 genes related to pharmacokinetics and pharmacodynamics of psychiatric medications. Each patient's genetic results were provided to participating clinicians, who completed a baseline survey including patient medications, history, and severity of illness. Clinicians were prompted to complete surveys within 1 week of receiving the genetic results and again 3 months later. Patients likewise completed assessments of depression, anxiety, medication side effects, and quality of life at baseline, 1 month, and 3 months. Data from 685 patients were collected. Approximately 70% and 29% of patients had primary diagnoses of either a mood or anxiety disorder, respectively. Clinician-reported data, as measured by the Clinical Global Impressions-Improvement scale, indicated that 87% of patients showed clinically measurable improvement (rated as very much improved, much improved, or minimally improved), with 62% demonstrating clinically significant improvement. When analysis was restricted to the 69% of individuals with ≥ 2 prior treatment failures, 91% showed clinically measurable improvement. Patients also reported significant decreases in depression (P < .001), anxiety (P < .001), and medication side effects (P < .001) and increases in quality of life (P < .001). These results suggest that a substantial proportion of individuals receiving pharmacogenetic testing showed clinically significant improvements on multiple measures of symptoms, adverse effects, and quality of life over 3 months. In the absence of a treatment-as-usual comparator, the proportion of improvement attributable to the test cannot be estimated. ClinicalTrials.gov identifier: NCT01507155.
| S-EPMC4560190 | biostudies-literature
Project description:Coronavirus disease-19 (COVID-19)-related anxiety and post-traumatic stress symptoms (PTSS) or post-traumatic stress disorder (PTSD) are likely to be a significant long-term issue emerging from the current pandemic. We hypothesize that cannabidiol (CBD), a chemical isolated from Cannabis sativa with reported anxiolytic properties, could be a therapeutic option for the treatment of COVID-19-related anxiety disorders. In the global over-the-counter CBD market, anxiety, stress, depression, and sleep disorders are consistently the top reasons people use CBD. In small randomized controlled clinical trials, CBD (300-800 mg) reduces anxiety in healthy volunteers, patients with social anxiety disorder, those at clinical high risk of psychosis, in patients with Parkinson's disease, and in individuals with heroin use disorder. Observational studies and case reports support these findings, extending to patients with anxiety and sleep disorders, Crohn's disease, depression, and in PTSD. Larger ongoing trials in this area continue to add to this evidence base with relevant patient cohorts, sample sizes, and clinical end-points. Pre-clinical studies reveal the molecular targets of CBD in these indications as the cannabinoid receptor type 1 and cannabinoid receptor type 2 (mainly in fear memory processing), serotonin 1A receptor (mainly in anxiolysis) and peroxisome proliferator-activated receptor gamma (mainly in the underpinning anti-inflammatory/antioxidant effects). Observational and pre-clinical data also support CBD's therapeutic value in improving sleep (increased sleep duration/quality and reduction in nightmares) and depression, which are often comorbid with anxiety. Together these features of CBD make it an attractive novel therapeutic option in COVID-related PTSS that merits investigation and testing through appropriately designed randomized controlled trials.
| S-EPMC7891214 | biostudies-literature
Project description:BACKGROUND: Over the past several decades, complementary and alternative medications have increasingly become a part of everyday treatment. With the rising cost of prescription medications and their production of unwanted side effects, patients are exploring herbal and other natural remedies for the management and treatment of psychological conditions. Psychological disorders are one of the most frequent conditions seen by clinicians, and often require a long-term regimen of prescription medications. Approximately 6.8 million Americans suffer from generalized anxiety disorder. Many also suffer from the spectrum of behavioural and physical side effects that often accompany its treatment. It is not surprising that there is universal interest in finding effective natural anxiolytic (anti-anxiety) treatments with a lower risk of adverse effects or withdrawal. METHODS: An electronic and manual search was performed through MEDLINE/PubMed and EBSCO. Articles were not discriminated by date of publication. Available clinical studies published in English that used human participants and examined the anxiolytic potential of dietary and herbal supplements were included. Data were extracted and compiled into tables that included the study design, sample population, intervention, control, length of treatment, outcomes, direction of evidence, and reported adverse events. RESULTS: A total of 24 studies that investigated five different CAM monotherapies and eight different combination treatments and involved 2619 participants met the inclusion criteria and were analyzed. There were 21 randomized controlled trials and three open-label, uncontrolled observational studies. Most studies involved patients who had been diagnosed with either an anxiety disorder or depression (n = 1786). However, eight studies used healthy volunteers (n = 877) who had normal levels of anxiety, were undergoing surgery, tested at the upper limit of the normal range of a trait anxiety scale, had adverse premenstrual symptoms or were peri-menopausal, reported anxiety and insomnia, or had one month or more of elevated generalized anxiety. Heterogeneity and the small number of studies for each supplement or combination therapy prevented a formal meta-analysis. Of the randomized controlled trials reviewed, 71% (15 out of 21) showed a positive direction of evidence. Any reported side effects were mild to moderate. CONCLUSIONS: Based on the available evidence, it appears that nutritional and herbal supplementation is an effective method for treating anxiety and anxiety-related conditions without the risk of serious side effects. There is the possibility that any positive effects seen could be due to a placebo effect, which may have a significant psychological impact on participants with mental disorders. However, based on this systematic review, strong evidence exists for the use of herbal supplements containing extracts of passionflower or kava and combinations of L-lysine and L-arginine as treatments for anxiety symptoms and disorders. Magnesium-containing supplements and other herbal combinations may hold promise, but more research is needed before these products can be recommended to patients. St. John's wort monotherapy has insufficient evidence for use as an effective anxiolytic treatment.
| S-EPMC2959081 | biostudies-other
Project description:Although previous research has supported the importance of anxiety as an etiological and maintenance factor for eating disorders, the specific mechanisms are not well understood. The role of anxiety in the context of eating behavior is especially unclear. The purpose of this study was to identify anxiety-eliciting eating situations and anxiety management strategies patients use to mitigate anxiety experienced in the context of eating as determined by diagnostic groups and symptom patterns. Fifty-three eating disorder outpatients were administered the Eating and Anxiety Questionnaire (EAQ) and the Eating Disorder Diagnostic Scale. Ratings indicated significant anxiety in most eating situations, whereas management strategies were more limited yet regularly employed. Factor analysis of the EAQ revealed a 6-factor solution for anxiety management strategies and a 4-factor solution for anxiety-eliciting situations. These results indicate patients with eating disorders report high levels of anxiety associated with eating behaviors but utilize limited yet consistent anxiety management strategies. Effective intervention strategies for managing eating-related anxiety should be incorporated into treatment and may need to be specified for different diagnostic subgroups.
| S-EPMC5558599 | biostudies-other
Project description:The study of inflammation in fear- and anxiety-based disorders has gained interest as growing literature indicates that pro-inflammatory markers can directly modulate affective behavior. Indeed, heightened concentrations of inflammatory signals, including cytokines and C-reactive protein, have been described in posttraumatic stress disorder (PTSD), generalized anxiety disorder (GAD), panic disorder (PD), and phobias (agoraphobia, social phobia, etc.). However, not all reports indicate a positive association between inflammation and fear- and anxiety-based symptoms, suggesting that other factors are important in future assessments of inflammation's role in the maintenance of these disorders (ie, sex, co-morbid conditions, types of trauma exposure, and behavioral sources of inflammation). The most parsimonious explanation of increased inflammation in PTSD, GAD, PD, and phobias is via the activation of the stress response and central and peripheral immune cells to release cytokines. Dysregulation of the stress axis in the face of increased sympathetic tone and decreased parasympathetic activity characteristic of anxiety disorders could further augment inflammation and contribute to increased symptoms by having direct effects on brain regions critical for the regulation of fear and anxiety (such as the prefrontal cortex, insula, amygdala, and hippocampus). Taken together, the available data suggest that targeting inflammation may serve as a potential therapeutic target for treating these fear- and anxiety-based disorders in the future. However, the field must continue to characterize the specific role pro-inflammatory signaling in the maintenance of these unique psychiatric conditions.
| S-EPMC5143487 | biostudies-literature
Project description:Aim: Guided Internet-delivered therapy has shown to be an effective treatment format for anxiety disorders. However, not all patients experience improvement, and although predictors of treatment outcome have been identified, few are consistent over time and across studies. The current study aimed to examine whether treatment self-efficacy (self-efficacy regarding the mastery of obstacles during treatment) in guided Internet-delivered therapy for anxiety disorders in adults could be a predictor of lower dropout rates and greater symptom reduction. Method: The analyzed data comes from an open effectiveness study including 575 patients receiving guided Internet-delivered therapy for panic disorder or social anxiety disorder. Treatment self-efficacy was measured at pre-treatment. Symptom reduction was measured at 10 measurement points, including a 6-month follow-up. A mixed linear model was applied in the analysis. Results: The results showed that high treatment self-efficacy was a predictor of both lower dropout rates and greater symptom reduction. Significant interaction effects between time and treatment self-efficacy were found for several of the nine modules that constitutes the treatment program, suggesting that treatment self-efficacy could be a moderator of symptom reduction. Three of nine modules in the panic disorder treatment and six of nine in the social anxiety disorder treatment showed significant interaction effects. Conclusion: The results suggest that measuring treatment self-efficacy may be a valuable tool to identify patients at risk of dropping out, and that treatment self-efficacy could be a predictor and moderator of symptom reduction in guided Internet-delivered therapy. The implications of the results are discussed.
| S-EPMC8566333 | biostudies-literature
Project description:BackgroundDisease trajectories of patients with anxiety disorders are highly diverse and approximately 60% remain chronically ill. The ability to predict disease course in individual patients would enable personalized management of these patients. This study aimed to predict recovery from anxiety disorders within 2 years applying a machine learning approach.MethodsIn total, 887 patients with anxiety disorders (panic disorder, generalized anxiety disorder, agoraphobia, or social phobia) were selected from a naturalistic cohort study. A wide array of baseline predictors (N = 569) from five domains (clinical, psychological, sociodemographic, biological, lifestyle) were used to predict recovery from anxiety disorders and recovery from all common mental disorders (CMDs: anxiety disorders, major depressive disorder, dysthymia, or alcohol dependency) at 2-year follow-up using random forest classifiers (RFCs).ResultsAt follow-up, 484 patients (54.6%) had recovered from anxiety disorders. RFCs achieved a cross-validated area-under-the-receiving-operator-characteristic-curve (AUC) of 0.67 when using the combination of all predictor domains (sensitivity: 62.0%, specificity 62.8%) for predicting recovery from anxiety disorders. Classification of recovery from CMDs yielded an AUC of 0.70 (sensitivity: 64.6%, specificity: 62.3%) when using all domains. In both cases, the clinical domain alone provided comparable performances. Feature analysis showed that prediction of recovery from anxiety disorders was primarily driven by anxiety features, whereas recovery from CMDs was primarily driven by depression features.ConclusionsThe current study showed moderate performance in predicting recovery from anxiety disorders over a 2-year follow-up for individual patients and indicates that anxiety features are most indicative for anxiety improvement and depression features for improvement in general.
| S-EPMC8711102 | biostudies-literature
Project description:Anxiety disorders are the most common psychiatric illnesses in the United States with approximately 30% of the population experiencing anxiety-related symptoms in their lifetime [Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE (2005) Lifetime prevalence and age-of-onset distributions of Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 62:593-60]. Notably, a variety of studies have demonstrated that 30-40% of the variance contributing to these disorders is heritable. In the present review, we discuss the latest findings regarding the genetic and environmental influences on the development and symptomatology of anxiety disorders. Specific emphasis is placed on posttraumatic stress disorder (PTSD) due to its uniqueness as an anxiety disorder; its diagnosis is dependent on a precipitating traumatic event and its development appears to be mediated by both genetic and environmental contributions. The co-morbidity of anxiety disorders and the potential re-classification of anxiety disorders as part of DSM-V are reviewed given the potential impact on the interpretation and design of genetic investigations. Lastly, several keys to future genetic studies are highlighted. Thorough analyses of the gene by environment (GxE) interactions that govern one's vulnerability to anxiety disorder(s), the effectiveness of individual treatment strategies, and the severity of symptoms may lead to more effective prophylactic (e.g. social support) and treatment strategies.
| S-EPMC2760665 | biostudies-literature