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Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial.

ABSTRACT: Background:The Unified Protocol for Emotional Disorders (UP) for emotional regulation manifests effective results in a broad range of mental disorders. The UP efficacy was tested in several countries, but it has not been tested within Mexican population. It is crucial to do more research and implement effective protocols to intervene Mexican population with Anxiety Disorders (AD). Objective:This study aims to examine and describe the research procedures and treatment interventions of the UP in a Randomized Controlled Trial (RCT), to approach and treat AD in patients in 2 Mexican borderland cities, by applying the UP and an Electroencephalogram (EGG) neuro screening. Methods:The enrolled patients will be randomized in a two-arm control trial with repeated measures, comprising between 18 and 60 years, that were diagnosed with an AD, and low scored in depression symptoms and suicidal ideation. The study will comprise of two conditions: an intervention group clinical trial with the UP or a waiting list control. The primary outcome measures will be applied on AD quantitative self-reports and a gamma activity by EGG before and after the intervention and in follow-ups of 3 and 6 months. The participants in the waiting list group, will receive the treatment after the trial first group completes the treatment. Conclusions:Processes and outcomes of this project, will provide evidence in order to apply the UP in a broader population with AD and other mental disorders also covered by this protocol, such as depression and borderline personality disorder in a broader Mexican population, a country that suffers with a major health issue with an increasing rate of mental disorders and scarce psychological and health coverage.

SUBMITTER: Dominguez-Rodriguez A

PROVIDER: S-EPMC7136174 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial.

Dominguez-Rodriguez A A Chavez-Valdez S M SM Avitia G C GC Valencia-Espinoza L C LC

Contemporary clinical trials communications 20200317

<h4>Background</h4>The Unified Protocol for Emotional Disorders (UP) for emotional regulation manifests effective results in a broad range of mental disorders. The UP efficacy was tested in several countries, but it has not been tested within Mexican population. It is crucial to do more research and implement effective protocols to intervene Mexican population with Anxiety Disorders (AD).<h4>Objective</h4>This study aims to examine and describe the research procedures and treatment interventions ...[more]

PMID: 32274440

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Project description:ImportanceTransdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments.ObjectiveTo determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders.Design, setting, and participantsFrom June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat.InterventionsThe UP or SDPs.Main outcomes and measuresBlinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs.ResultsAmong the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs.Conclusions and relevanceThe UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders.Trial registrationclinicaltrials.gov Identifier: NCT01243606.

Project description:BackgroundAnxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program.ObjectiveThe primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting.MethodsA cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed.ResultsWe have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017.ConclusionsWe expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers.Trial registrationClinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR).

Project description:BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has been an emotionally challenging time, especially for young adults. It is associated with a substantial increase in the prevalence of mental health problems, negative symptoms, and stressful experiences that compromise well-being. In low-income countries, internet-delivered psychological services could have a remarkable impact on the population's mental health, given the lack of mental health professionals.AimTo investigate the efficacy of internet-delivered cognitive-behavior therapy (CBT)-transdiagnostic intervention for adults with emotional disorders.MethodsIn this internet-delivered randomized controlled trial, 102 students with an emotional disorder (mean age = 28.20 years, standard deviation = 5.07) were randomly allocated to receive unified protocol (UP) (n = 51) or treatment as the usual intervention. Following a semi-structured clinical interview, participants completed an online survey including the Overall Anxiety Severity and Impairment Scale, Overall Depression Severity and Impairment Scale, Difficulties in Emotion Regulation Scale, Positive and Negative Affect Schedule, and Emotional Style Questionnaire.ResultsThe participants showed a high degree of adherence. In total, 78% (n = 40) of the experimental group participants completed the UP treatment. Considering the intention to treat procedure, the results of the analysis of covariance indicated that participants who received UP showed statistically significant changes in depression symptoms [Cohen's d = -1.50 with 95% confidence interval (CI): -1.90 to -1.10], anxiety (Cohen's d = -1.06 with 95%CI: -1.48 to -0.65), difficulties with emotion regulation (Cohen's d = -0.33 with 95%CI: -0.7 to -0.06), positive affect (Cohen's d = 1.27 with 95%CI: 0.85 to 1.68), negative affect (Cohen's d= -1.04 with 95%CI: -1.46 to -0.63), and healthy emotionality (Cohen's d = 0.53 with 95%CI: 0.09 to 0.13) compared with the control group.ConclusionThis study's findings highlight the potential value of transdiagnostic internet-delivered programs for young adults with an emotional disorder during the COVID-19 pandemic, and expand the research examining emotional well-being improvements resulting from CBT-transdiagnostic interventions. The findings suggest that UP, which generally concentrates on reducing negative effects, can increase positive effects.

Project description:BACKGROUND:Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials. METHODS:Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected. DISCUSSION:The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03113175 and NCT03113201 . Registered on 13 April 2017.

Project description:BackgroundThe U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks.MethodsAdult smokers (N = 200) of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General). Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg). After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a) quit smoking with assistance, (b) continue smoking free research cigarettes, or (c) return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and 1-hydroxypyrene, oxidative stress biomarkers including 8-isoprostanes, measures of psychiatric symptoms (e.g., depression, anxiety), smoking behavior and dependence (e.g., cigarette consumption, quit attempts), and health effects (e.g., blood pressure, respiratory symptoms).DiscussionResults from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes.Trial registrationTRN: NCT01928758 , registered August 21, 2013.

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Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial.

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Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial.

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