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During the COVID-19 outbreak, there was a sharp increase in generalized anxiety disorder (GAD). Acupuncture therapy has the advantages of accurate clinical efficacy, safety and reliability, few adverse reactions, and no dependence, and is gradually becoming one of the emerging therapies for treating GAD. We present a study protocol for a randomized clinical trial with the aim of exploring the mechanism of brain plasticity in patients with GAD and evaluate the effectiveness and reliability of acupuncture treatment. Transcranial magnetic stimulation (TMS) will be used to assess cortical excitability in GAD patients and healthy people. Sixty-six GAD patients meeting the inclusion criteria will be randomly divided into two groups: TA group, (treatment with acupuncture and basic western medicine treatment) and SA group (sham acupuncture and basic western medicine treatment). Twenty healthy people will be recruited as the control group (HC). The parameters that will be evaluated are amplitude of motor evoked potentials (MEPs), cortical resting period (CSP), resting motor threshold (RMT), and Hamilton Anxiety Scale (HAMA) score. Secondary results will include blood analysis of γ-aminobutyric acid (GABA), glutamate (Glu), glutamine (Gln), serotonin (5-HT), and brain-derived nerve growth factor (BDNF). Outcomes will be assessed at baseline and after the intervention (week 8). This study protocol is the first clinical trial designed to detect differences in cerebral cortical excitability between healthy subjects and patients with GAD, and the comparison of clinical efficacy and reliability before and after acupuncture intervention is also one of the main contents of the protocol. We hope to find a suitable non-pharmacological alternative treatment for patients with GAD.

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BACKGROUND: Transcranial magnetic stimulation (TMS) has been shown to improve response and remission in patients with treatment resistant depression. The objective of this study was to compare the efficacy of two bilateral rTMS protocols with different protocols in patients with treatment resistant depression and comorbid severe anxiety. METHODS: A retrospective cohort study involving 67 patients who underwent two different bilateral TMS protocols and who met the specified eligibility criteria was conducted. Group 1 received stimulation with 85% RMT intermittent theta burst (iTBS) in the left DLPFC + 120% RMT (1 Hz) in the right DLPFC. Group 2 received stimulation with 100% RMT (iTBS) in the left DLPFC + 110% RMT (1 Hz) in the left DLPFC. RESULTS: After the magnetic stimulation treatment, 55% (n=22) achieved response to depression symptoms in group 1 and 62% (n=18) in group 2. Remission of depression symptoms was achieved in 13% in group 1 (n=5) and 24% in group 2 (n=7). There were no significant differences between the two protocols after TMS CONCLUSIONS: Different bilateral protocol parameters in individuals undergoing TMS may have an impact on symptom response and remission. Further studies with larger sample sizes are needed.

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Introduction: The Unified Protocol (UP) is a psychotherapeutic intervention that has proven to be effective for the transdiagnostic treatment of emotional disorders, both in individual and group format. Recently, its virtual application through teletherapy has begun to be studied. In a previous pilot study carried out in Argentina in a sample of 7 subjects, significant decreases were observed in levels of depression, difficulties in emotional regulation, hopelessness and negative affect and a significant increase in quality of life after having applied the PU in virtual and group format to people with emotional disorders. Method: The present work aims to evaluate the maintenance of the results observed in this study after three months. Results: No statistically significant differences were observed in any of the variables analyzed, which shows that the results achieved have been maintained. Discussion: The UP is presented as a promising intervention for the treatment of emotional disorders in a virtual and group format, although further research is required in order to generalize the results.

Introducción: El Protocolo Unificado (PU) es una intervención psicoterapéutica que ha demostrado ser efectiva para el tratamiento transdiagnóstico de los trastornos emocionales, tanto en formato individual como grupal. Recientemente, comenzó a estudiarse su aplicación de manera virtual a través de teleterapia. En un estudio piloto previo realizado en Argentina en una muestra de 7 sujetos se observaron disminuciones significativas en niveles de depresión, dificultades en la regulación emocional, desesperanza y afecto negativo y un aumento significativo en calidad de vida luego de haber aplicado el PU en formato virtual y grupal a personas con trastornos emocionales. Método: El presente trabajo pretende evaluar el mantenimiento a los tres meses de los resultados observados en dicho estudio. Resultados: No se observaron diferencias estadísticamente significativas en  ninguna de las variables analizadas, lo que da cuenta de un mantenimiento de los resultados alcanzados. Discusión: El PU se presenta como una  intervención prometedora para el tratamiento de trastornos emocionales en formato virtual y grupal, aunque se requiere mayor investigación con el objetivo de generalizar los resultados.

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BACKGROUND: The Unified Protocol (UP) is a transdiagnostic intervention based on emotional regulation for the treatment of emotional disorders. Its application in individual and group formats has been studied worldwide, obtaining similar results to specific protocols but with a lower drop-out rate and improving the cost-benefit ratio, since a larger number of patients can benefit from it. Moreover, the inclusion of digital technologies in psychotherapy aims to improve the accessibility of treatments, especially since the pandemic of COVID-19 that forced the implementation of treatments through teletherapy increasing its use. To date, no studies have been carried out in Argentina on the application of the UP in a group format and through teletherapy. The aim of the present study is to evaluate the efficacy of the UP in a group format and through teletherapy in the Argentine population. METHODS: A parallel-group, controlled, randomized trial, with pre-post and repeated follow-up measures intergroup design will be conducted. One hundred eighty patients will be randomized to one of the following conditions: an online, group-based UP intervention or a waiting list. The Beck Depression Inventory-II and the Beck Anxiety Inventory will be used to compare primary outcomes and the Beck Hopelessness Scale, Difficulties in Emotion Regulation Scale, Positive Affect and Negative Affect Scale, and Multicultural Quality of Life Index will be administered for secondary outcomes at baseline, post-intervention, and 3 months follow-up. Ad-hoc questionnaires will be used to assess patients' experiences and treatment satisfaction. DISCUSSION: The purpose of this trial is to evaluate the efficacy of the online and group application of the UP in the Argentine population, as well as to evaluate the patient's experience and satisfaction with the treatment. It is expected that the findings of this study will be useful in reducing anxious and depressive symptomatology, will allow us to adapt the UP to our culture, and will improve accessibility to treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05275322. Registered on 11 March 2022.

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Importance: A transdiagnostic treatment, the Unified Protocol, is as effective as single diagnostic protocols in comorbid emotional disorders in clinical populations. However, its effects on posttraumatic stress disorder and other emotional disorders in individuals living in war and armed conflict contexts have not been studied. Objective: To evaluate the efficacy of a cultural and contextual adaptation of the Unified Protocol (CXA-UP) on posttraumatic stress disorder, anxiety, and depression compared to waitlist control in individuals exposed to armed conflict in Colombia. Design, Setting, and Participants: From April 2017 to March 2020, 200 participants 18 years and older were randomly assigned to the CXA-UP or to a waitlist condition. CXA-UP consisted of 12 to 14 twice-a-week or weekly individual 90-minute face-to-face sessions. Outcomes were assessed at baseline, posttreatment, and 3 months following treatment. Analyses were performed and compared for all randomly allocated participants (intent-to-treat [ITT]) and for participants who completed all sessions and posttreatment measures (per protocol [PP]). The study took place at an outpatient university center and included individuals who were registered in the Colombian Victims Unit meeting DSM-5 diagnostic criteria for posttraumatic stress disorder, anxiety, or depression or were severely impaired by anxiety or depression. Individuals who were receiving psychological therapy, were dependent on alcohol or drugs, were actively suicidal or had attempted suicide in the previous 2 months, had psychosis or bipolar disorder, or were cognitively impaired were excluded. Intervention: CXA-UP or waitlist. Main Outcomes and Measures: Primary outcomes were changes in anxiety, depression, and somatic scores on the Patient Health Questionnaire and Posttraumatic Stress Disorder Checklist for DSM-5. Results: Among the 200 participants (160 women [80.0%]; 40 men [20.0%]; mean [SD] age, 43.1 [11.9] years), 120 were randomized to treatment and 80 to waitlist. Results for primary outcomes in the ITT analysis showed a significant pretreatment-to-posttreatment reduction when comparing treatment and waitlist on the posttraumatic stress disorder checklist for DSM-5 scores (slope [SE], -31.12 [3.00]; P < .001; Cohen d, 0.90; 90% CI, 0.63-1.19), 9-item Patient Health Questionnaire (PHQ-9) (slope [SE],-11.94 [1.30]; P < .001; Cohen d, 0.77; 90% CI, 0.52-1.06), PHQ-anxiety (slope [SE], -6.52 [0.67]; P < .001; Cohen d, 0.82; 90% CI, 0.49-1.15), and PHQ-somatic (slope [SE], -8.31 [0.92]; P < .001; Cohen d, 0.75; 90% CI, 0.47-1.04). Conclusions and Relevance: In this study, significant reductions and large effect sizes in all measures of different emotional disorders showed efficacy of a single transdiagnostic intervention in individuals exposed to armed conflicts. Trial Registration: ClinicalTrials.gov Identifier: NCT03127982.

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Importance: Guided internet-delivered cognitive behavioral therapy (i-CBT) is a low-cost way to address high unmet need for anxiety and depression treatment. Scalability could be increased if some patients were helped as much by self-guided i-CBT as guided i-CBT. Objective: To develop an individualized treatment rule using machine learning methods for guided i-CBT vs self-guided i-CBT based on a rich set of baseline predictors. Design, Setting, and Participants: This prespecified secondary analysis of an assessor-blinded, multisite randomized clinical trial of guided i-CBT, self-guided i-CBT, and treatment as usual included students in Colombia and Mexico who were seeking treatment for anxiety (defined as a 7-item Generalized Anxiety Disorder [GAD-7] score of ≥10) and/or depression (defined as a 9-item Patient Health Questionnaire [PHQ-9] score of ≥10). Study recruitment was from March 1 to October 26, 2021. Initial data analysis was conducted from May 23 to October 26, 2022. Interventions: Participants were randomized to a culturally adapted transdiagnostic i-CBT that was guided (n = 445), self-guided (n = 439), or treatment as usual (n = 435). Main Outcomes and Measures: Remission of anxiety (GAD-7 scores of ≤4) and depression (PHQ-9 scores of ≤4) 3 months after baseline. Results: The study included 1319 participants (mean [SD] age, 21.4 [3.2] years; 1038 women [78.7%]; 725 participants [55.0%] came from Mexico). A total of 1210 participants (91.7%) had significantly higher mean (SE) probabilities of joint remission of anxiety and depression with guided i-CBT (51.8% [3.0%]) than with self-guided i-CBT (37.8% [3.0%]; P = .003) or treatment as usual (40.0% [2.7%]; P = .001). The remaining 109 participants (8.3%) had low mean (SE) probabilities of joint remission of anxiety and depression across all groups (guided i-CBT: 24.5% [9.1%]; P = .007; self-guided i-CBT: 25.4% [8.8%]; P = .004; treatment as usual: 31.0% [9.4%]; P = .001). All participants with baseline anxiety had nonsignificantly higher mean (SE) probabilities of anxiety remission with guided i-CBT (62.7% [5.9%]) than the other 2 groups (self-guided i-CBT: 50.2% [6.2%]; P = .14; treatment as usual: 53.0% [6.0%]; P = .25). A total of 841 of 1177 participants (71.5%) with baseline depression had significantly higher mean (SE) probabilities of depression remission with guided i-CBT (61.5% [3.6%]) than the other 2 groups (self-guided i-CBT: 44.3% [3.7%]; P = .001; treatment as usual: 41.8% [3.2%]; P < .001). The other 336 participants (28.5%) with baseline depression had nonsignificantly higher mean (SE) probabilities of depression remission with self-guided i-CBT (54.4% [6.0%]) than guided i-CBT (39.8% [5.4%]; P = .07). Conclusions and Relevance: Guided i-CBT yielded the highest probabilities of remission of anxiety and depression for most participants; however, these differences were nonsignificant for anxiety. Some participants had the highest probabilities of remission of depression with self-guided i-CBT. Information about this variation could be used to optimize allocation of guided and self-guided i-CBT in resource-constrained settings. Trial Registration: ClinicalTrials.gov Identifier: NCT04780542.

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OBJECTIVE: To identify and evaluate the quality of mobile apps available in Brazil focused on the care of patients with anxiety disorders. METHODS: A comprehensive search was conducted until October 2021 on Play Store (Android) and Apple Store (iOS) in Brazil, using the terms "anxiety," "phobia," "panic attack," and "social phobia." Two independent authors identified the apps and performed data extraction and quality assessment using the Mobile App Rating Scale (MARS). Pearson's correlation was used to analyze the relationship between user star rating and the quality defined by the MARS instrument. RESULTS: A total of 3,278 potential apps were identified, of which 71 fully met the eligibility criteria. Most apps were made available on the Play Store (91.74%), in English (69.01%), and updated in the last two years (90.14%). Approximately half of the apps (50.70%) did not inform the developer's country and most of them did not report the user star rating (70.42%). The target population was indicated as free by most apps (85.92%), with generalized anxiety disorder being the most addressed disorder (74.65%), followed by panic disorder (33.80%). The three main purposes of the apps were education (83.10%), self-assessment (38.03%), and meditation/breathing (32.39%). Only 31 apps (43.66%) had acceptable quality (above 3.0) and the average total MARS quality score of 2.93 (2.20 to 3.90), with the functionality section receiving the highest score (3.90) and the lowest scoring sections being engagement (2.16). The apps that were rated stars by users (29.58%) showed a negative Pearson correlation (ρ = -0.100), evidencing a difference in the user's evaluation and that performed using the MARS instrument. CONCLUSION: Gaps in the quality of apps focused on the care of patients with anxiety disorders were evidenced since most were classified as having low quality through the MARS instrument. Thus, users are recommended to use these apps with caution.

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OBJECTIVES: Anxiety and depression are prevalent in the elderly and lead to loss of functionality and increased mortality. Although the use of antidepressants and face-to-face psychotherapies are indicated, the current context of telemedicine provides an alternative, with the advantage of facilitating access to care. The study aimed to evaluate the efficacy of telemedicine interventions to reduce anxiety and depression in the elderly through a systematic review with meta-analysis. METHODS: The systematic review, through a search in 7 databases, included studies that evaluated the use of telemedicine interventions for depressive or anxious symptoms in the elderly, compared with usual care or waiting list or with another telemedicine intervention. Quantitative assessment was performed through meta-analysis. RESULTS: A total of 31 articles identified in the search met the eligibility criteria and four were included for meta-analysis. Studies showed that telemedicine interventions are feasible and several studies demonstrated significant improvement in depressive or anxiety symptoms. Four studies evaluated the efficacy of internet-delivered cognitive behavioral therapy for depression and anxiety in older adults, compared with a waitlist, and found pooled effect sizes of -1.20 (95% CI -1.60 to -0.81) and -1.14 (95% CI -1.56 to -0.72), respectively, with low heterogeneity. CONCLUSIONS: Telemedicine interventions can be an alternative for the treatment of mood and anxiety symptoms in the elderly. However, more studies are needed to prove their clinical effectiveness, especially in countries with lower incomes and diverse culture and education.

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Background: The comorbidity of anxiety and drug use disorders complicates treatment prognosis, and one of the greatest challenges is to address the environmental and behavioral factors involved. The aim of this study was to describe the uses of intervention mapping in the design of a theory and evidence-based complex intervention to develop skills around the management of anxiety for cocaine users in outpatient addiction treatment. Methods: The six steps of the intervention mapping approach, which are needs assessment, creation of matrices of performance objectives, selection of methods and practical strategies, program development, adoption and implementation, and evaluation were applied to develop the Interpersonal Theory of nursing to Anxiety management in people with Substance Use Disorders (ITASUD) intervention. The theory used for the conceptual model was interpersonal relations theory. All theory-based methods and practical applications were developed at the individual level, acting in behavioral, interpersonal, organizational and community environments. Results: The intervention mapping provided a broad overview of the problem and outcome expectations. The ITASUD intervention consists of five consecutive sessions of 110-min targeting individual determinants of anxiety (knowledge, triggers, relief behaviors, self-efficacy and relations), delivered by a trained nurse using Peplau's concepts of interpersonal relations. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change. Conclusions: The intervention mapping approach increases the effectiveness of the intervention since the matrices provide a broad view of all factors that affect the problem and facilitate replication through transparency of the determinants, methods, and applications used. ITASUD addresses all factors that play an important role in substance use disorders based on a theoretical basis, which provides the translation of evidence from research into effective practice, policy, and public health improvements.

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Specific phobias are a common anxiety disorder that deteriorates the lives of people who suffer from them. To reduce the symptoms produced by this mental disorder exposure therapies have been used. However, low- and middle-income countries, including Mexico, have the lowest rate of treatment due to multiple barriers that prevent addressing mental health problems. Self-applied treatments have been explored in previous studies, nevertheless, high dropout rates are a common problem in this kind of treatment. An alternative is using immersive self-applied treatments that could help increase adherence to the treatment. This article aims to present a study protocol to explore the feasibility of an Internet self-applied exposure treatment for rat phobias, using four types of immersive multimedia elements: images, videos, video games, and 360° videos. Also, the satisfaction and perception of a Virtual Therapy Assistant (VTA) that provides information and support to the user are described. The study protocol will compare two groups of participants, one on the waiting list, and the other will receive the self-applied treatment for rat phobia supported by the VTA. For this study, 45 participants will be recruited and the evaluation measures will be taken at four different times: baseline, post-treatment, and follow-ups at 3 and 6 months. The levels of anxiety and avoidance of the user manifested during the exposure to the multimedia elements, the improvement of the user's clinical symptoms, the level of satisfaction, the perception of effectiveness, and ease of use of the self-applied system will be evaluated. This study is expected to support the viability of self-applied treatment for rat phobias and the use of a VTA, showing the impact on treatment adherence. To the best of our knowledge, this is the first study to explore an exposure treatment for rats using different multimedia elements with the support of a VTA. The work will serve as a basis for the development of new virtual assistants that help in the treatment of other types of specific phobias. This research has been registered in Clinical Trials NCT (NCT05081323).

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Activation of the insula is found in all anxiety-related disorders and increased insular-prefrontal cortex (PFC) functional connectivity is associated with reduced anxiety. In this study, the combined stimulation of the insula and PFC using the dTMS H4 (insula+LPFC) and H2 (PFC) coils were used to reduce anxiety in 13 subjects experiencing occupational stress, and 55 participants suffering from generalized anxiety disorder (GAD). The combined HF stimulation of the insula and PFC significantly decreased anxiety scores according to the HARS, CAS, and STAI anxiety scales, leading to a reduction in anxiety according to HARS of 88.7% and 70.7% in participants with occupational stress and the clinical sample of participants diagnosed with GAD, respectively. The findings suggest that the prefrontal-insular axis is critical for the regulation of anxiety and its stimulation can be used for the treatment of anxiety in people suffering from occupational stress and GAD.

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The impact of childhood experiences on the development of psychopathology is well established in the literature. Few studies, however, have assessed parental bonding during childhood as a predictor of response to anxiety disorders treatment. The aim of the study was to examine whether emotional memories of childhood parenting could predict short-term and long-term outcome in three different interventions for patients with generalized anxiety disorder (GAD): mindfulness-based intervention (Body in Mind Training [BMT]), fluoxetine (FLX), and an active control group (quality of life [QoL]). A total of 124 participants from a randomized controlled trial for GAD treatment were evaluated pre- and post-treatment and after 18 months. Patients were assessed for the severity of GAD symptoms (GAD-7, PSWQ, and DERS), early memories of warmth and safeness (EMWSS), and recall of perceived threat and subordination/submission in childhood (ELES). Negative childhood memories predicted a greater reduction in anxiety symptoms on BMT treatment compared to FLX and QoL, whereas positive childhood memories predicted more symptomatic improvement in the QoL group. Our findings suggest that individuals with GAD who have early memories of subordination and threat appear to benefit more from interventions that focus on developing emotion-regulation strategies and enhancing self-compassion, such as mindfulness-based interventions.

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BACKGROUND: Generalized anxiety disorder (GAD) is associated with the lowest treatment response rate among all anxiety disorders. Understanding mechanisms of improvement may help to develop more effective and personalized treatments. AIM: The objective of the study was to investigate different improvement mechanisms in the treatment of individuals diagnosed with GAD. DESIGN: We reported data from a randomized controlled trial that evaluated three different GAD treatments (mindfulness-based intervention, BMT; fluoxetine, FLX; and an active comparison group, QoL) for 8 weeks. METHOD: Mediation analyses were performed evaluating the association between worry symptoms at baseline and anxiety scoring at the endpoint, considering self-compassion or mindfulness or its dimensions at mid-treatment as mediators for the whole sample (assessing GAD improvement mechanism) and the different interventions as moderators. RESULTS: Contrary to mindfulness state scoring (C = .06; 95% CI = -.05 to .20), self-compassion (C = .11; 95% CI = .01 to .28) and non-judgement of inner experience (C = .10; 95% CI = .004 to .21) mediated the association between worry symptoms at baseline and anxiety at the endpoint. When comparing BMT to FLX, the intervention modality did not moderate these associations. CONCLUSION: Self-compassion and non-judgement of inner experience seem to be essential targets in GAD treatment, contrary to the mindfulness state itself. Although no difference was found considering the intervention modality, future research may assess how to boost these dimensions in specific treatments for GAD.

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INTRODUCTION: Metacognitive beliefs about worry may trigger anxiety. However, the effect of generalized anxiety disorder (GAD) treatment on metacognition has not yet been investigated. OBJECTIVES: To validate the Metacognitions Questionnaire (MCQ-30) in a Brazilian GAD sample and verify whether different interventions reduce metacognitive beliefs. METHOD: We recruited 180 GAD individuals and randomized them to Body in Mind Training (BMT), Fluoxetine (FLX), or an active control group (Quality of Life [QoL]) for 8 weeks. The MCQ-30 was assessed for internal consistency, was evaluated with confirmatory and exploratory factor analyses, and was tested for convergent validity with the Penn State Worry Questionnaire (PSWQ). Generalized estimating equations (GEE) were employed to analyze differences after the interventions. RESULTS: The MCQ-30 demonstrated good internal consistency and acceptability; the original five-factor model was supported. There was a positive moderate correlation between MCQ-30 scores and worry. GEE showed a significant group x time interaction (p < 0.001). Both BMT (mean difference [MD] = -6.04, standard error [SE] = -2.39, p = 0.034) and FLX (MD = -5.78, SE = 1.91, p = 0.007) reduced MCQ-30 scores. FLX was superior to QoL, but not BMT, at weeks 5 and 8. There were no differences between BMT and QoL. CONCLUSION: The Brazilian-Portuguese version of MCQ-30 showed good psychometric properties. Furthermore, the positive effect of FLX and BMT on metacognition suggests it may represent a potential therapeutic target.

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OBJECTIVE: This study explores in cognitive-behavioral therapy (CBT) for generalized anxiety disorder (GAD) to what degree therapists' perceptions of their patients as interpersonally challenging (IC) is explained by the therapist or patient effects, if baseline patients' characteristics predict IC, and if IC is related to outcome. METHOD: Eighty patients diagnosed with GAD and treated by 20 therapists with 16 sessions of CBT were randomized to two different implementation conditions. Patients completed baseline measures of depression, anxiety, interpersonal problems, and interpersonal strengths. The therapists completed a single-item assessing IC session-by-session. As an outcome, patients completed a worry measure at baseline, session 5, session 10, and posttreatment. RESULTS: Multilevel models showed meaningful therapist effects, explaining 18% of IC variance. Interpersonal strengths were the only baseline predictor significantly and negatively associated with IC during treatment. Structural equation models showed significant negative IC effects on subsequent patient worry during therapy. CONCLUSIONS: IC might represent a risk factor for psychotherapy outcome. Patient interpersonal strengths at baseline may buffer therapists perceiving their patients as ICs. The therapist effects on IC suggest that CBT clinicians treating GAD might benefit from identifying cases that are interpersonally challenging for them and reflecting about what might trigger that perception.

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BACKGROUND: Emotional and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. Reasons include limited access and low availability to effective interventions and comorbidity between mental disorders. Emotional deregulation of negative affectivity has been found to be a mediating factor in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In addition, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported intervention programs have been empirically tested for effectiveness, efficiency and efficacy and can be key to ensuring access to those who are inaccessible. The aim of the study is to evaluate the efficacy, moderators of clinical change and acceptability of a transdiagnostic guided Internet-delivered intervention versus a transdiagnostic self-guided Internet-delivered intervention for emotional, trauma and stress-related disorders, and waiting list in community sample. METHODS: A three-armed, parallel group, superiority randomized controlled clinical trial with repeated measurements at four times: pretest, posttest, follow-up at 3, 6 and 12 months. Outcomes assessor, participant, care provider and investigator will be blinded. Participants aged 18 to 70 years will be randomly allocated 1:1:1 to one of three study arms: a) Transdiagnostic guided internet-delivered intervention with synchronous assistance, b) Transdiagnostic self-guided internet-delivered intervention, c) Waiting list group. Based on sample size estimation, a minimum of 207 participants (69 in each intervention group) will be included. DISCUSSION: The study could contribute to improving the efficacy of transdiagnostic internet-delivered interventions to promote the dissemination of evidence-based treatments and eventually, to decrease the high prevalence of emotional and trauma-related disorders in the Mexican population. TRIAL REGISTRATION: ClinicalTrial.gov: NCT05225701 . Registered February 4, 2022.

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BACKGROUND: Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent among university students and predict impaired college performance and later life role functioning. Yet most students do not receive treatment, especially in low-middle-income countries (LMICs). We aim to evaluate the effects of expanding treatment using scalable and inexpensive Internet-delivered transdiagnostic cognitive behavioral therapy (iCBT) among college students with symptoms of MDD and/or GAD in two LMICs in Latin America (Colombia and Mexico) and to investigate the feasibility of creating a precision treatment rule (PTR) to predict for whom iCBT is most effective. METHODS: We will first carry out a multi-site randomized pragmatic clinical trial (N = 1500) of students seeking treatment at student mental health clinics in participating universities or responding to an email offering services. Students on wait lists for clinic services will be randomized to unguided iCBT (33%), guided iCBT (33%), and treatment as usual (TAU) (33%). iCBT will be provided immediately whereas TAU will be whenever a clinic appointment is available. Short-term aggregate effects will be assessed at 90 days and longer-term effects 12 months after randomization. We will use ensemble machine learning to predict heterogeneity of treatment effects of unguided versus guided iCBT versus TAU and develop a precision treatment rule (PTR) to optimize individual student outcome. We will then conduct a second and third trial with separate samples (n = 500 per arm), but with unequal allocation across two arms: 25% will be assigned to the treatment determined to yield optimal outcomes based on the PTR developed in the first trial (PTR for optimal short-term outcomes for Trial 2 and 12-month outcomes for Trial 3), whereas the remaining 75% will be assigned with equal allocation across all three treatment arms. DISCUSSION: By collecting comprehensive baseline characteristics to evaluate heterogeneity of treatment effects, we will provide valuable and innovative information to optimize treatment effects and guide university mental health treatment planning. Such an effort could have enormous public-health implications for the region by increasing the reach of treatment, decreasing unmet need and clinic wait times, and serving as a model of evidence-based intervention planning and implementation. TRIAL STATUS: IRB Approval of Protocol Version 1.0; June 3, 2020. Recruitment began on March 1, 2021. Recruitment is tentatively scheduled to be completed on May 30, 2024. TRIAL REGISTRATION: ClinicalTrials.gov NCT04780542 . First submission date: February 28, 2021.

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OBJECTIVE: Generalized anxiety disorder (GAD) is a chronic and disabling disorder associated with various impairments and shows a significant prevalence in the worldwide and Brazilian populations. This study aimed to investigate the longitudinal relationship of two symptoms relevant to the disorder (worry and depressive symptoms) in the context of a randomized clinical trial (RCT) by using a cross-lagged panel model (CLPM) analysis. METHODS: A total of 92 adult patients with GAD were randomized to receive ten sessions of either acceptance­based group behavioral therapy (ABBT) or nondirective supportive group therapy (NDST). Treatment had four time-point measures. Worries were measured using the Penn State Worry Questionnaire (PSWQ), and depression was measured using the Depression Anxiety Stress Scales (DASS-D). RESULTS: The NDST model revealed significant paths from worry to depression (first wave) and from depression to worry (second wave). There was no other significant cross-lagged effect. These data show that there was an influence between symptoms only during one of the treatment groups, and without a homogeneous and constant pattern in any of the cross-lagged routes. CONCLUSION: A supportive group psychotherapy potentially interferes with the pattern of the direct relationship between worries and depressive symptoms in adults with GAD.

OBJETIVO: O transtorno de ansiedade generalizada (TAG) é um diagnóstico crônico e incapacitante, associado a diversos prejuízos e com relevante prevalência na população mundial e na brasileira. Este estudo tem por objetivo investigar a relação longitudinal de duas manifestações relevantes para o transtorno (preocupação e sintomas depressivos), utilizando uma análise cross-lagged panel model (CLPM) por meio de dados de um ensaio clínico randomizado (ECR). MÉTODOS: Um total de 92 pacientes adultos com TAG foi randomizado para duas psicoterapias em grupo: terapia comportamental baseada em aceitação (TCBA) ou terapia de apoio não diretiva (TAND). Cada grupo teve duração de 10 sessões, distribuídas em 14 semanas. O tratamento teve quatro tempos de medida: linha de base, meio do tratamento, pós-tratamento e seguimento de três meses. As variáveis investigadas foram: preocupações, medidas pelo Penn State Worry Questionnaire (PSWQ), e sintomas depressivos, medidos pela Depression Anxiety Stress Scales (DASS-D). Os modelos CLMP foram gerados pelo programa Mplus. RESULTADOS: O modelo do grupo TAND revelou duas rotas significativas: preocupação para sintomas depressivos (primeira onda) e sintomas depressivos para preocupação (segunda onda). Não houve outro efeito cross-lagged que obteve significância estatística. Esses dados mostram que houve influência alternada entre os sintomas somente durante o período de um dos dois tratamentos testados, configurando um padrão heterogêneo das rotas cross-lagged. CONCLUSÃO: A psicoterapia suportiva em grupo potencialmente interfere no padrão da relação direta entre preocupação e sintomas depressivos em adultos com TAG.

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