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.
Project description:<h4>Background</h4>Emotional 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.<h4>Objective</h4>This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample.<h4>Methods</h4>A 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.<h4>Results</h4>Within-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.<h4>Conclusions</h4>Overall, 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.<h4>Trial registration</h4>ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758.<h4>International registered report identifier (irrid)</h4>RR2-10.1186/s12888-017-1297-z.
Project description:BACKGROUND:Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system. MS is significantly associated with a high rate of psychological, behavioral, and emotional consequences. Despite the frequent mental disorders, high rate of psychological comorbidities, and emotional problems in people with MS (PwMS), these conditions are often underdiagnosed and undertreated. This study aimed to examine the efficacy of a group format of the unified protocol for the transdiagnostic treatment of emotional disorders in adult PwMS associated with an emotional disorder. METHODS:Seventy adult PwMS were randomized using an internet-based computer system to either the unified protocol (n?=?35) or treatment as usual condition. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional dysregulation, and affectivity. RESULTS:The parametric test of analysis of covariance, followed the intent to treat analyses, revealed the unified protocol significantly changed depression symptoms (Cohen's d?=?1.9), anxiety symptoms (Cohen's d?=?2.16), worry symptoms (Cohen's d?=?1.27), emotion dysregulation (Cohen's d?=?0.44), positive affect (Cohen's d?=?1.51), and negative affect (Cohen's d?=?1.89) compared with the control group. The unified protocol also significantly improved outcome scores at the end of treatment relative to baseline (p?<?.001). CONCLUSION:The findings support that the unified protocol could be an additional efficient psychological treatment for PwMS. Trial registration IRCT, number: IRCT20190711044173N1. Registered 31october 2019, https://en.irct.ir/user/trial/40779/view .
Project description:Emotional 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.The 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.Although 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.ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.
Project description:BACKGROUND:There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS:The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION:To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION:Clinicalstrials.gov as NCT03159715 . Registered 19 May 2017.
Project description:The advantages of transdiagnostic protocols for emotional disorders (ED) (anxiety and depression) include the ability to treat multiple psychological disorders using the same treatment protocol, and the capacity to better address comorbidity. Comorbidity in ED has been associated with higher rates of severity, functional impairment, and chronicity. However, no attempts have been made in the literature to systematically review whether these studies include assessments to evaluate the treatment response in comorbid diagnoses, in addition to the principal diagnosis. Moreover, transdiagnostic treatments have been developed for a range of ED, but to date no study has analyzed the real distribution of diagnoses in these studies. The current study aimed to analyze: a) whether treatment response in comorbidity is evaluated in transdiagnostic treatments for ED; b) what diagnoses are targeted in transdiagnostic treatments for ED; and c) the real distribution of the diagnoses at baseline in these studies. A systematic search of the literature was conducted in PsycINFO, PubMed, EMBASE, and the Cochrane Library. Fifty-two randomized controlled trials were identified, with a total of 7007 adult participants. The results showed that, although most of the studies reported data on comorbidity at baseline, only 40% of them examined the effects of the intervention on the comorbid disorders. The most commonly targeted diagnoses in transdiagnostic protocols were panic/agoraphobia, generalized anxiety, social anxiety, and depression. Other disorders, such as obsessive-compulsive disorder, posttraumatic stress disorder, and anxiety/depression not otherwise specified, were marginally included in these studies. Regarding the distribution of diagnoses at baseline, generalized anxiety, panic/agoraphobia, social anxiety, and depression were the most frequently observed, whereas depression not otherwise specified was the least represented. The results highlight the importance of assessing comorbidity in addition to the principal diagnoses in transdiagnostic treatments, in order to draw conclusions about the true potential of these interventions to improve comorbid symptoms. Implications of the current study and directions for future research are discussed.
Project description:Common emotional and behavioral symptoms co-occur and are associated with core temperament factors. This study investigated links between temperament and dimensional, latent psychopathology factors, including a general common psychopathology factor (p factor) and specific latent internalizing and externalizing liabilities, as captured by a bifactor model, in two independent samples of youth. Specifically, we tested the hypothesis that temperament factors of negative affectivity (NA), positive affectivity (PA), and effortful control (EC) could serve as both transdiagnostic and specific risks in relation to recent bifactor models of child psychopathology. Sample 1 included 571 youth (average age 13.6, SD =2.37, range 9.3-17.5) with both youth and parent report. Sample 2 included 554 preadolescent children (average age 7.7, SD =1.35, range =5-11 years) with parent report. Structural equation modeling showed that the latent bifactor models fit in both samples. Replicated in both samples, the p factor was associated with lower EC and higher NA (transdiagnostic risks). Several specific risks replicated in both samples after controlling for co-occurring symptoms via the p factor: internalizing was associated with higher NA and lower PA, lower EC related to externalizing problems.
Project description:Cognitive behaviour therapy delivered in the format of guided self-help via the internet has been found to be effective for a range of conditions, including depression and anxiety disorders. Recent results indicate that guided self-help via the internet is a promising treatment format also for psychodynamic therapy. However, to date and to our knowledge, no study has evaluated internet-delivered psychodynamic therapy as a transdiagnostic treatment. The affect-phobia model of psychopathology by McCullough et al provides a psychodynamic conceptualisation of a range of psychiatric disorders. The aim of this study will be to test the effects of a transdiagnostic guided self-help treatment based on the affect-phobia model in a sample of clients with depression and anxiety.This study will be a randomised controlled trial with a total sample size of 100 participants. The treatment group receives a 10-week, psychodynamic, guided self-help treatment based on the transdiagnostic affect-phobia model of psychopathology. The treatment consists of eight text-based treatment modules and includes therapist contact in a secure online environment. Participants in the control group receive similar online therapist support without any treatment modules. Outcome measures are the 9-item Patient Health Questionnaire Depression Scale and the 7-item Generalised Anxiety Disorder Scale (GAD-7). Process measures that concerns emotional processing and mindfulness are included. All outcome and process measures will be administered weekly via the internet and at 6-month follow-up.This trial will add to the body of knowledge on internet-delivered psychological treatments in general and to psychodynamic treatments in particular. We also hope to provide new insights in the effectiveness and working mechanisms of psychodynamic therapy based on the affect-phobia model.
Project description:<h4>Background</h4>Multiple sclerosis (MS) is a chronic, unpredictable, neurodegenerative disease, significantly associated with psychological, behavioral, cognitive, and emotional consequences. MS is more common in females than males and frequently affects women during their reproductive years. Despite the frequent mental disorders, comorbidities, and emotional problems in People with MS (PwMS), these conditions are too often underdiagnosed and undertreated.<h4>Objective</h4>This study aimed to examine the efficacy of a group format of the Unified Protocol (UP) for the Transdiagnostic treatment of depression and anxiety disorders in females with MS.<h4>Methods</h4>In the present study, Sixty-four adult females diagnosed with MS were randomized to either the UP (n?=?32) or treatment-as-usual conditions. The assessment protocol included semi-structured clinical interviews and self-reports evaluating diagnostic criteria, depression, anxiety and worry symptoms, emotional regulation, and affectivity.<h4>Results</h4>Repeated measure analysis of variance (ANOVA) revealed that the UP significantly improved depression scores [Cohen's d?=?-?2.11, 95% CI (-?2.72, -?1.50)], anxiety scores [Cohen's d?=?-?3.34, 95% CI (-?4.01, -?2.58)], positive and negative affect scale (PANAS)-positive affect scores [Cohen's d?=?1.46, 95% CI (1.46, 2.01)], PANAS-negative affect scores [Coen's d?=?-?2.21, 95% CI (-?2.84, -?1.60)], difficulties emotion regulation scale scores [Cohen's d?=?1.40, 95% CI (-?0.87, -?0.03)], and Worry scale scores [Cohen's d?=?-?0.45, 95% CI (-?0.95, -?0.04)] at the end of treatment relative to compared to the control condition. Also, treatment gains were maintained at the three-month follow-up (p?<?0.001).<h4>Conclusion</h4>The findings provide the support that the UP could be an additional efficient psychological treatment for females with MS. ISRCTN Number: ISRCTN95459505.
Project description:<h4>Introduction</h4>Emotional 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.<h4>Method and analysis</h4>A 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.<h4>Ethics and dissemination</h4>The 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.<h4>Trial registration</h4>ClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.
Project description:Obesity is currently becoming a serious global public health problem due to its high prevalence and continuous increase. This condition is associated with different physical and mental health problems. The presence of emotional disorders (anxiety, depression and related disorders) among candidates for bariatric surgery is very high and predicts worse physical and psychological results. The present study aims to explore the feasibility and clinical usefulness of the Unified Protocol, a transdiagnostic emotion regulation-based intervention, delivered in an online group format to patients with emotional disorder diagnosis or symptoms, who are waiting for bariatric surgery. We will conduct a pilot study with a repeated single-case experimental design (multiple baseline design) in a public mental health service. The sample will consist of 60 participants, who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Diagnostic criteria, symptomatology and body mass index are the primary outcome measures, and we will include affectivity, personality, quality of life, body image, eating behavior and surgical complications like secondary measures. An analysis of treatment satisfaction will be also performed. Assessment points will include pre-treatment, baseline, treatment, post-treatment, and follow-ups every three months until two years after post-treatment. The results obtained in this study may have important clinical, social and economic implications for public mental health.