Predictors of anxiety recurrence in the Coordinated Anxiety Learning and Management (CALM) trial.
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ABSTRACT:
SUBMITTER: Taylor JH
PROVIDER: S-EPMC4492801 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
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Project description:Most patients with anxiety disorders receive treatment in primary care settings. Limited moderator data are available to inform clinicians of likely prognostic outcomes for individual patients. We identify baseline characteristics associated with outcome in adults seeking treatment for anxiety disorders.We conducted an exploratory moderator analysis from the Coordinated Anxiety Learning and Management (CALM) trial. In the CALM trial, 1,004 adults who met DSM-IV criteria for generalized anxiety disorder (GAD), panic disorder, social anxiety disorder, and/or posttraumatic stress disorder (PTSD) were randomized to usual care (UC) or a collaborative care intervention (ITV) of cognitive-behavioral therapy and/or pharmacotherapy between June 2006 and April 2008. Logistic regression was used to examine baseline characteristics associated with remission and response overall and by treatment condition. Receiver operating curve (ROC) analyses identified subgroups associated with similar likelihood of response and remission of global anxiety symptoms. Remission was defined as score < 6 on the 12-item Brief Symptom Inventory (BSI-12) anxiety and somatization subscales. Response was defined as at least 50% reduction on BSI-12, or meeting remission criteria.Randomization to ITV over UC was often the strongest predictor of outcome. Several baseline patient characteristics were associated with poor treatment outcome including comorbid depression, increased severity of underlying anxiety disorder(s) (P < .001), low socioeconomic status (perceived [P < .001] and actual [P < .05]), and limited social support (P < .001). Patient characteristics associated with particular benefit from ITV were being female (P < .05), increased depression (P < .01)/GAD severity (P < .05), and low socioeconomic status (P < .05). ROC analysis demonstrated prognostic subgroups with large differences in response likelihood.Further research should focus on the effectiveness of implementing the ITV intervention of CALM in community treatment centers where patients typically are of low socioeconomic status and may particularly benefit from ITV.ClinicalTrials.gov identifier: NCT00347269.
| S-EPMC4930076 | biostudies-literature
Project description:BackgroundImproving the quality of mental health care requires integrating successful research interventions into 'real-world' practice settings. Coordinated Anxiety Learning and Management (CALM) is a treatment-delivery model for anxiety disorders encountered in primary care. CALM offers cognitive behavioral therapy (CBT), medication, or both; non-expert care managers assisting primary care clinicians with adherence promotion and medication optimization; computer-assisted CBT delivery; and outcome monitoring. This study describes incremental benefits, costs and net benefits of CALM versus usual care (UC).MethodThe CALM randomized, controlled effectiveness trial was conducted in 17 primary care clinics in four US cities from 2006 to 2009. Of 1062 eligible patients, 1004 English- or Spanish-speaking patients aged 18-75 years with panic disorder (PD), generalized anxiety disorder (GAD), social anxiety disorder (SAD) and/or post-traumatic stress disorder (PTSD) with or without major depression were randomized. Anxiety-free days (AFDs), quality-adjusted life years (QALYs) and expenditures for out-patient visits, emergency room (ER) visits, in-patient stays and psychiatric medications were estimated based on blinded telephone assessments at baseline, 6, 12 and 18 months.ResultsOver 18 months, CALM participants, on average, experienced 57.1 more AFDs [95% confidence interval (CI) 31-83] and $245 additional medical expenses (95% CI $-733 to $1223). The mean incremental net benefit (INB) of CALM versus UC was positive when an AFD was valued ≥$4. For QALYs based on the Short-Form Health Survey-12 (SF-12) and the EuroQol EQ-5D, the mean INB was positive at ≥$5000.ConclusionsCompared with UC, CALM provides significant benefits with modest increases in health-care expenditures.
| S-EPMC3340455 | biostudies-literature
Project description:When treating anxious patients with co-occurring depression, research demonstrates that both types of symptoms independently improve. The current analyses examined how reductions in anxiety and depression may be interrelated both during treatment, as well as over time following treatment. Participants were 503 individuals with one or more DSM-IV anxiety disorders who completed a collaborative care anxiety management program. Anxiety and depression were assessed at each treatment session (i.e., session by session data) and also at 6, 12, and 18-month post-baseline assessments (i.e., long-term outcomes data). Mediation analyses examined changes in symptoms in session by session data and long-term outcomes data. Anxiety and depression changed reciprocally in session by session data; change in anxiety mediated change in depression to a greater extent than vice versa. In the long-term outcomes data, change in anxiety mediated change in depression. However, the reverse mediation model of the long-term outcomes period revealed that accounting for changes in depression altered the effect of time on anxiety. Thus, temporal change during active treatment may share similarities with those related to maintaining gains after treatment, although differences arose in the reverse mediation models. Limitations of the methodology and implications of anxiety treatment for depression outcomes are discussed.
| S-EPMC4656042 | biostudies-literature
Project description:Although self-efficacy (SE) and outcome expectancy (OE) have been well researched as predictors of outcome, few studies have investigated changes in these variables across treatments. We evaluated changes in OE and SE throughout treatment as predictors of outcomes in a large sample with panic disorder, generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder. We hypothesized that increases in SE and OE would predict reductions in anxiety and depression as well as improvement in functioning.Participants (mean age = 43.3 years, SD = 13.2, 71.1% female, 55.5% white) were recruited from primary care centers throughout the United States and were randomized to receive either Coordinated Anxiety Learning and Management (CALM) treatment - composed of cognitive behavioral therapy, psychotropic medication, or both - or usual care. SE and OE ratings were collected at each session for participants in the CALM treatment (n = 482) and were entered into a structural equation model as predictors of changes in Brief Symptom Inventory, Anxiety Sensitivity Index, Patient Health Questionnaire (PHQ), and Sheehan Disability Scale outcomes at 6, 12, and 18 months after baseline.The best-fitting models predict symptom levels from OE and SE and not vice versa. The slopes and intercept of OE significantly predicted change in each outcome variable except PHQ-8. The slope and intercept of SE significantly predicted change in each outcome variable.Over and above absolute level, increases in SE and OE were significant predictors of decreases in symptoms and increases in functioning. Implications for treatment are discussed, as well as future directions of research.
| S-EPMC4244230 | biostudies-literature
Project description:Management of chordoid meningiomas (CMs) is complicated by high rates of recurrence, particularly following subtotal resection. Optimal management is not established given the paucity of published experience. To identify prognostic factors for recurrence following resection, the authors conducted the largest systematic review of CMs to date. A comprehensive search on MEDLINE (OVID and Pubmed), Scopus, Embase, and Web of Science utilizing the search terms "chordoid" AND "meningioma" was performed to identify all reports of pathologically confirmed intracranial CMs. A total of 221 patients were included, comprising 120 females and 101 males. Mean age, MIB-1/Ki67, and tumor size was 45.5 years, 4.3% (range 0.1-26.6%), and 4.1 cm (range 0.8-10 cm), respectively. 5-, and 10- year progression free survival was 67.5 and 54.4%, respectively. Gross total resection (GTR) and subtotal resection was achieved in 172 and 48 patients, respectively. Adjuvant radiotherapy (RT) was given to 30 patients. Multivariate analysis found GTR was strongly correlated with decreased recurrence rates (HR 0.04, p = <0.0001), while higher MIB-1 labeling index (?5 vs <5%) was associated with increased recurrence (HR 7.08; p = 0.016). Adjuvant RT, age, gender, and tumor location were not associated with recurrence. GTR resection is the strongest predictor of tumor control, and should be the goal to minimize local progression. Additionally, higher MIB-1 labeling was associated with increased rates of tumor recurrence. Tumors that are subtotally resected or demonstrate higher MIB-1 are at greater recurrence and warrant consideration for RT and close long term follow up.
| S-EPMC4684776 | biostudies-literature
Project description:Symptomatic recurrence of Clostridium difficile infection (CDI) occurs in approximately 20% of patients and is challenging to treat. Identifying those at high risk could allow targeted initial management and improve outcomes. Adult toxin enzyme immunoassay-positive CDI cases in a population of approximately 600,000 persons from September 2006 through December 2010 were combined with epidemiological/clinical data. The cumulative incidence of recurrence ? 14 days after the diagnosis and/or onset of first-ever CDI was estimated, treating death without recurrence as a competing risk, and predictors were identified from cause-specific proportional hazards regression models. A total of 1678 adults alive 14 days after their first CDI were included; median age was 77 years, and 1191 (78%) were inpatients. Of these, 363 (22%) experienced a recurrence ? 14 days after their first CDI, and 594 (35%) died without recurrence through March 2011. Recurrence risk was independently and significantly higher among patients admitted as emergencies, with previous gastrointestinal ward admission(s), last discharged 4-12 weeks before first diagnosis, and with CDI diagnosed at admission. Recurrence risk also increased with increasing age, previous total hours admitted, and C-reactive protein level at first CDI (all P < .05). The 4-month recurrence risk increased by approximately 5% (absolute) for every 1-point increase in a risk score based on these factors. Risk factors, including increasing age, initial disease severity, and hospital exposure, predict CDI recurrence and identify patients likely to benefit from enhanced initial CDI treatment.
| S-EPMC3388024 | biostudies-literature
Project description:ObjectiveDetermine if group psychoeducational support can improve in vitro fertilization (IVF) patients' quality of life (QoL).DesignRandomized controlled trial (NCT04048772).SettingUniversity-affiliated IVF clinic.PatientsWomen (n = 76) and male partners undergoing initial autologous IVF cycle from August 2019, to December 2020.InterventionsCouples were assigned to groups based on projected oocyte retrieval date. Groups were randomly assigned to the control or intervention arm. Clinic closures because of the COVID-19 pandemic delayed treatment for a portion of participants. Groups were conducted in person before and virtually during the pandemic.Main outcome measuresThe primary outcome was a change in fertility quality of life (FertiQoL) from baseline to 3 days after retrieval. Secondary outcomes were changes in depression (Patient Health Questionnaire 9), anxiety (Generalized Anxiety Disorder 7), resilience (Connor-Davidson Resilience scale), IVF knowledge scores, and the likelihood of return to treatment.ResultsKnowledge scores among women in Creating Affiliations, Learning, and Mindfulness (CALM) for IVF groups significantly increased compared with control (mean difference 13.19 [3.53 - 22.84]) before the pandemic. During the pandemic, women in CALM IVF had significant improvement in the social FertiQoL score compared with controls (10.42 [1.79 - 19.04]). Compared with controls, male CALM IVF participants had significantly greater improvement in total FertiQoL (mean difference 6.68 [0.39 - 12.98]), treatment FertiQoL (8.26 [0.69 - 15.82]), and resilience (Connor-Davidson 1.13 [0.54 - 1.72]). Immediate return to care did not significantly differ between arms.ConclusionsFor women undergoing IVF, group psychoeducational programs can improve IVF knowledge and social QoL during a pandemic. Participation in a group psychoeducational program can improve QoL and resilience in IVF dyad male partners.Clinical trial registration numberTrial registration NCT04048772.
| S-EPMC10028477 | biostudies-literature
Project description:Investigators recently tested the effectiveness of a collaborative-care intervention for anxiety disorders: Coordinated Anxiety Learning and Management(CALM) []) in 17 primary care clinics around the United States. Investigators also conducted a qualitative process evaluation. Key research questions were as follows: (1) What were the facilitators/barriers to implementing CALM? (2) What were the facilitators/barriers to sustaining CALM after the study was completed?Key informant interviews were conducted with 47 clinic staff members (18 primary care providers, 13 nurses, 8 clinic administrators, and 8 clinic staff) and 14 study-trained anxiety clinical specialists (ACSs) who coordinated the collaborative care and provided cognitive behavioral therapy. The interviews were semistructured and conducted by phone. Data were content analyzed with line-by-line analyses leading to the development and refinement of themes.Similar themes emerged across stakeholders. Important facilitators to implementation included the perception of "low burden" to implement, provider satisfaction with the intervention, and frequent provider interaction with ACSs. Barriers to implementation included variable provider interest in mental health, high rates of part-time providers in clinics, and high social stressors of lower socioeconomic-status patients interfering with adherence. Key sustainability facilitators were if a clinic had already incorporated collaborative care for another disorder and presence of onsite mental health staff. The main barrier to sustainability was funding for the ACS.The CALM intervention was relatively easy to incorporate during the effectiveness trial, and satisfaction was generally high. Numerous implementation and sustainability barriers could limit the reach and impact of widespread adoption. Findings should be interpreted with the knowledge that the ACSs in this study were provided and trained by the study. Future research should explore uptake of CALM and similar interventions without the aid of an effectiveness trial.
| S-EPMC3319426 | biostudies-literature
Project description:BackgroundMiddle-aged adults (40-65 years) report higher stress levels than most other age groups. There is a need to determine the feasibility of using a meditation app to reduce stress and improve stress-related outcomes in middle-aged adults with a focus on men, as previous meditation app-based studies have reported a low proportion of or even no male participants.ObjectiveThis study aims to (1) determine the feasibility (ie, acceptability and demand with a focus on men) of a consumer-based meditation app (Calm), to reduce stress among middle-aged adults reporting elevated stress levels, and (2) explore the preliminary effects of Calm on perceived stress, psychological outcomes (anxiety, depressive symptoms, mindfulness, and general coping), health behaviors (physical activity and eating habits), and COVID-19 perceptions.MethodsThis feasibility randomized controlled trial evaluated an app-based meditation intervention in middle-aged adults (N=83) with elevated stress levels (ie, Perceived Stress Scale score ≥15) and limited or no previous experience with meditation. Participants were randomized to the intervention group (Calm app) or a control (educational podcasts; POD) group. Participants completed self-report assessments at baseline and postintervention (week 4). Feasibility was measured as acceptability and demand using Bowen framework. Feasibility and COVID-19 perceptions data were examined using descriptive statistics, and preliminary effects were evaluated using repeated measures analysis of variance.ResultsParticipants were satisfied with Calm (27/28, 96%) and found it appropriate or useful (26/28, 93%). Most reported they would likely continue using the Calm app (18/28, 64%). More Calm users reported satisfaction, appropriateness or usefulness, and intent to continue app use than POD users. Calm users (n=33) completed a mean of 20 (SD 31.1) minutes of meditation on the days they meditated and 103 (SD 109.1) minutes of meditation per week. The average adherence rate to the prescribed meditation was 71% among Calm app users, compared to 62% among POD users. Recruitment rate of men was 35% (29/83). Of those randomized to Calm, 55% (15/29) were men, and retention among them was higher (14/15, 93%) than that among women (12/20, 60%). No significant within or between group differences were observed.ConclusionsA 4-week, app-based mindfulness meditation intervention (Calm) may be feasible for middle-aged adults and a useful stress-management tool. Calm users expressed satisfaction with the app and felt it was appropriate and useful. Significant improvements in perceived stress and psychological outcomes or stress-related health behaviors were not observed. Even though men spent less time in meditation than women did and completed fewer weekly sessions, they were more likely to adhere to the prescription. Further research is needed for improving stress and stress-related outcomes among middle-aged adults with emphasis on the effects of mindfulness meditation apps for men.Trial registrationClinicalTrials.gov NCT04272138; https://clinicaltrials.gov/ct2/show/NCT04272138.
| S-EPMC9132144 | biostudies-literature
Project description:BACKGROUND & AIMS: Sorafenib is the standard systemic therapy for advanced hepatocellular carcinoma (HCC). In early-stage HCC, survival benefits of resection/local ablation are compromised by high recurrence rates (70% at 5-years). In this setting, the phase-3 STORM-trial did not achieve its primary end-point of improving recurrence-free-survival (RFS) comparing sorafenib to placebo as adjuvant treatment. Herein we present results of the biomarker companion study BIOSTORM in which we define predictors of recurrence prevention with sorafenib and prognostic factors with B-level of evidence. METHODS: Tumor tissue from 188 patients randomized to receive sorafenib (83) or placebo (105) in the STORM trial was collected. Analyses included gene-expression profiling, targeted exome sequencing (18 known onco-drivers), immunohistochemistry (pERK, pVEGFR2, Ki67), FISH (VEGFA) and immunome. A gene signature capturing improved RFS in sorafenib-treated patients was generated. All 70 RFS events were recurrences, thus time-to-recurrence equaled RFS. Predictive and prognostic value was assessed using Cox regression models and interaction test. RESULTS: BIOSTORM recapitulates clinical and pathological characteristics of STORM patients. None of the biomarkers tested that are known to be related to angiogenesis and proliferation, or previously proposed gene-signatures, or mutations predicted sorafenib benefit. A newly generated 146-gene signature identifying 30% of patients captured benefit to sorafenib in terms of RFS (p-of-interaction=0.04). These sorafenib responders were significantly enriched in CD4+ T, B, and cytolytic Natural Killer cells, and showed absence of activated macrophages and other components of adaptive immunity. Hepatocytic pERK (HR=2.41; p=0.012) and microvascular invasion (HR=2.09; p=0.017) were independent prognostic factors. CONCLUSIONS: In BIOSTORM, hepatocytic pERK and microvascular invasion predicted poor RFS. No mutation, gene amplification or previously proposed gene-signatures predicted sorafenib benefit. A newly generated multi-gene signature associated with improved RFS on sorafenib warrants further validation. KEYWORDS: sorafenib; tyrosine-kinase inhibitor; trial enrichment; stratification.
2018-08-21 | GSE109211 | GEO