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Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT dissemination encompass different perspectives. One is the transdiagnostic approach, which offers treatment protocols that can be used for a range of emotional disorders. Another approach is the use of the internet to reach a larger number of people who could benefit from CBT. OBJECTIVE:This study aimed to analyze the effectiveness and acceptability of a transdiagnostic internet-delivered protocol (EmotionRegulation) with human and automated guidance in patients from public specialized mental health care settings. METHODS:A 2-armed randomized controlled trial (RCT) was conducted to compare the effectiveness of EmotionRegulation with treatment as usual (TAU) in specialized mental health care. In all, 214 participants were randomly assigned to receive either EmotionRegulation (n=106) or TAU (n=108). Measurement assessments were conducted at pre- and postintervention and at a 3-month follow-up. RESULTS:The results revealed the superiority of EmotionRegulation over TAU on measures of depression (d=0.41), anxiety (d=0.35), and health-related quality of life (d=-0.45) at posttreatment, and these gains were maintained at the 3-month follow-up. Furthermore, the results for expectations and opinions showed that EmotionRegulation was well accepted by participants. CONCLUSIONS:EmotionRegulation was more effective than TAU for the treatment of emotional disorders in the Spanish public mental health system. The implications of this RCT, limitations, and suggestions for future research are discussed. TRIAL REGISTRATION:ClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.

SUBMITTER: Gonzalez-Robles A

PROVIDER: S-EPMC7381075 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.

González-Robles Alberto A Díaz-García Amanda A García-Palacios Azucena A Roca Pablo P Ramos-Quiroga Josep Antoni JA Botella Cristina C

Journal of medical Internet research 20200707 7

<h4>Background</h4>Anxiety disorders and depression (emotional disorders) are highly prevalent mental disorders. Extensive empirical evidence supports the efficacy of cognitive behavioral therapy (CBT) for the treatment of these disorders. However, there are still some barriers related to their dissemination and implementation, which make it difficult for patients to receive these treatments, especially in public health care settings where resources are limited. Recent advances in improving CBT ...[more]

PMID: 32673226

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Project description:BackgroundEmotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied.Methods/designThe study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed.DiscussionAlthough the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed.Trial registrationClinicalTrials.gov NCT02345668 . Registered 27 July 2015.

Project description:BackgroundTransdiagnostic internet-delivered cognitive behavioral therapy (iCBT) for emotional disorders has been shown to be effective in specialized care in the short term. However, less is known about its long-term effects in this specific setting. In addition, predictors of long-term effectiveness may help to identify what treatments are more suitable for certain individuals.ObjectiveThis study aimed to analyze the long-term effectiveness of transdiagnostic iCBT compared with that of treatment as usual (TAU) in specialized care and explore predictors of long-term effectiveness.MethodsMixed models were performed to analyze the long-term effectiveness and predictors of transdiagnostic iCBT (n=99) versus TAU (n=101) in public specialized mental health care. Outcomes included symptoms of depression and anxiety, health-related quality of life (QoL), behavioral inhibition and behavioral activation, comorbidity, and diagnostic status (ie, loss of principal diagnosis) from baseline to 1-year follow-up. Sociodemographic characteristics (sex, age, and education) and clinical variables (principal diagnosis, comorbidity, and symptom severity at baseline) were selected as predictors of long-term changes.ResultsCompared with baseline, transdiagnostic iCBT was more effective than TAU in improving symptoms of depression (b=-4.16, SE 1.80, 95% CI -7.68 to -0.67), health-related QoL (b=7.63, SE 3.41, 95% CI 1.00-14.28), diagnostic status (b=-0.24, SE 0.09, 95% CI -1.00 to -0.15), and comorbidity at 1-year follow-up (b=-0.58, SE 0.22, 95% CI -1.00 to -0.15). From pretreatment assessment to follow-up, anxiety symptoms improved in both transdiagnostic iCBT and TAU groups, but no significant differences were found between the groups. Regarding the predictors of the long-term effectiveness of transdiagnostic iCBT compared with that of TAU, higher health-related QoL at follow-up was predicted by a baseline diagnosis of anxiety, male sex, and the use of psychiatric medication; fewer comorbid disorders at follow-up were predicted by older age and higher baseline scores on health-related QoL; and fewer depressive symptoms at follow-up were predicted by baseline diagnosis of depression. However, this pattern was not observed for baseline anxiety diagnoses and anxiety symptoms.ConclusionsThe results suggest that transdiagnostic iCBT is more effective than TAU to target depressive symptoms among patients with emotional disorders. Anxiety symptoms remained stable at 1-year follow-up, with no differences between the groups. Results on predictors suggest that some groups of patients may obtain specific gains after transdiagnostic iCBT. Specifically, and consistent with the literature, patients with baseline depression improved their depression scores at follow-up. However, this pattern was not found for baseline anxiety disorders. More studies on the predictor role of sociodemographic and clinical variables in long-term outcomes of transdiagnostic iCBT are warranted. Future studies should focus on studying the implementation of transdiagnostic iCBT in Spanish public specialized mental health care.Trial registrationClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.

Project description:BackgroundEmotional 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.MethodsA 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.DiscussionThe 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 registrationClinicalTrial.gov: NCT05225701 . Registered February 4, 2022.

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:BackgroundEmotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health.ObjectiveThis study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample.MethodsA 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed.ResultsWithin-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol.ConclusionsOverall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component.Trial registrationClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758.International registered report identifier (irrid)RR2-10.1186/s12888-017-1297-z.

Project description:BACKGROUND:Demand for primary care (PC) services in Spain exceeds available resources. Part of this strong demand is due to the high prevalence of emotional disorders (EDs)-anxiety, depression, and somatic symptom disorders-and related comorbidities such as pain or chronic illnesses. EDs are often under- or misdiagnosed by general practitioners (GPs) and, consequently, treatment is frequently inadequate. OBJECTIVE:We aim to compare the short- and long-term effectiveness of group-delivered transdiagnostic cognitive behavioral therapy (TD-CBT) versus treatment as usual (TAU) in the treatment of EDs in the PC setting in Spain. We also aim to compare the effect of these treatments on disability, quality of life, cognitive-emotional factors, and treatment satisfaction. METHODS:Here we present the study design of a two-arm, single-blind, randomized controlled trial (N=1126) to compare TAU to TD-CBT for EDs. TAU will consist primarily of pharmacological treatment and practical advice from the GP while TD-CBT will be administered in seven 90-minute group sessions held over a period ranging from 12 to 14 weeks. Psychological assessments are carried out at baseline (ie, pretreatment); posttreatment; and at 3-, 6-, and 12-month follow-up. The study is conducted in approximately 26 PC centers from the National Health System in Spain. RESULTS:This study was initiated in December 2013 and will remain open to new participants until recruitment and follow-up has been completed. We expect all posttreatment evaluations to be completed by December 2017, and follow-up will end in December 2018. CONCLUSIONS:We expect the TD-CBT group to have better results compared to TAU on all posttreatment measures and that this improvement will be maintained during follow-up. This project could serve as a model for use in other areas or services of the National Health System in Spain and even in other countries. CLINICALTRIAL:International Standard Randomized Controlled Trial Number (ISRCTN): 58437086; http://www.isrctn.com/ISRCTN58437086 (Archived by WebCite at http://www.webcitation.org/6mbYjQSn3).

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.

Dataset Information

Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.

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Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial.

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