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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial.

ABSTRACT: Emotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affectivity. The data suggest the existence of disturbances in positive affectivity in these disorders, and so new interventions focusing on these problems are greatly needed. It is also essential to provide assistance to all the people in need. Information and Communication Technologies can be very useful. This study aims to evaluate the efficacy of a transdiagnostic Internet-based treatment for ED in a community sample. The protocol includes traditional CBT components, as well as a specific component to address positive affect. We intend to test this protocol, including this specific component or not, versus a waiting list control group. Moreover, we aim to test the differential effect of this specific component, and study the effectiveness (in terms of patients' acceptance) of using a self-applied Internet-based program. This paper presents the study protocol.The study is a randomized controlled trial. 207 participants will be randomly assigned to: a)Transdiagnostic Internet-based protocol (TIBP), b)Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA), or c)a Waiting List control group (WL). Primary outcomes measures will be the BDI-II, the BAI, and the PANAS. Secondary outcomes will include diagnosis-specific measures of the principal disorder. Participants' treatment acceptance will also be measured. Participants will be assessed at pre-, post-treatment, and 3- and 12- month follow-ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed.To the best of our knowledge, this is the first study of a transdiagnostic Internet-based treatment for ED with a specific component to up-regulate positive affectivity. This intervention could contribute to improve the efficiency and effectiveness of current treatment programs for ED, promote the dissemination of EBTs, and help to decrease the high prevalence of ED.ClinicalTrial.gov: NCT02578758 . Registered 15 October 2015.

SUBMITTER: Diaz-Garcia A

PROVIDER: S-EPMC5397807 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial.

Díaz-García Amanda A González-Robles Alberto A Fernández-Álvarez Javier J García-Palacios Azucena A Baños Rosa María RM Botella Cristina C

BMC psychiatry 20170420 1

<h4>Background</h4>Emotional disorders (ED) are among the most prevalent mental disorders. However, less than 50% of people suffering from ED receive the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which tries to address the underlying processes common to ED. Most of these programs focus primarily on down-regulating negative affectivity, rather than increasing strengths and up-regulating positive affecti ...[more]

PMID: 28424068

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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: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:IntroductionEmotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial.Method and analysisA one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed.Ethics and disseminationThe trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal.Trial registrationClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

Project description:BackgroundAnxiety 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.ObjectiveThis 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.MethodsA 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.ResultsThe 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.ConclusionsEmotionRegulation 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 registrationClinicalTrials.gov NCT02345668; https://clinicaltrials.gov/ct2/show/NCT02345668.

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.

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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial.

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Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial.

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