The unified protocol as an internet-based intervention for emotional disorders: Randomized controlled trial.
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SUBMITTER: Schaeuffele C
PROVIDER: S-EPMC9273095 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
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The unified protocol as an internet-based intervention for emotional disorders: Randomized controlled trial.
Schaeuffele Carmen C Homeyer Sophie S Perea Luis L Scharf Lisa L Schulz Ava A Knaevelsrud Christine C Renneberg Babette B Boettcher Johanna J
PloS one 20220711 7
The Unified Protocol (UP) as a transdiagnostic intervention has primarily been applied in the treatment of anxiety disorders and in face-to-face-settings. The current study investigated the efficacy of a 10-week Internet-based adaptation of the UP for anxiety, depressive, and somatic symptom disorders. The trial was registered under DRKS00014820 at the German Clinical Trial Registry, DRKS. Participants (n = 129) were randomized to treatment or waitlist control. Significant treatment effects were ...[more]
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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.
| S-EPMC9453349 | biostudies-literature
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.
| S-EPMC7884218 | biostudies-literature
Project description:BackgroundResearch reveals a high prevalence of stressors in adolescence. Mental health in adolescence is highly related to life-stressors exposure and difficulties in adjusting to stressors. Therefore, interventions for recovery from stress are in high demand. The study aims to evaluate the efficacy of the Internet-based stress recovery intervention for adolescents.MethodsA two-arm randomized controlled trial (RCT) on the efficacy of the FOREST-A-an Internet-based stress recovery intervention for adolescents-will be conducted. The FOREST-A is an adapted version of stress recovery intervention initially developed for healthcare workers. FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based Internet-delivered 4-week psychosocial intervention, which comprises six modules: Introduction, Relaxation, Psychological detachment, Mastery, Control, and Summary. The intervention will be evaluated using the two-arm RCT with intervention and care as usual (CAU) condition at pre-test, post-test, and 3-month follow-up. The measured outcomes will be stress recovery, adjustment disorder, generalized anxiety and depression symptoms, psychological well-being, and perceived positive social support.DiscussionThe study will contribute to the development of Internet interventions-easily and broadly accessible tools-for the enhancement of adolescents' stress recovery skills. Based on the study's findings, further development of the FOREST-A, including upscaling and implementation, is foreseen.Trial registrationClinicalTrials.gov NCT05688254. Registered on January 6, 2023.
| S-EPMC9996863 | biostudies-literature
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.
| S-EPMC9360670 | biostudies-literature
Project description:BACKGROUND:Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. METHODS:A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. DISCUSSION:The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population. TRIAL REGISTRATION:ClinicalTrial.gov: NCT02758418 . Trial registration date 2 May 2016.
| S-EPMC5984386 | biostudies-literature
Project description:BackgroundE-mental health has become increasingly popular in interventions for individuals with eating disorders (EDs). It has the potential to offer low-threshold interventions and guide individuals to the needed care more promptly. Featback is such an Internet-based intervention and consists of psychoeducation and a fully automated monitoring and feedback system. Preliminary findings suggest Featback to be (cost-)effective in reducing ED symptomatology. Additionally, e-mail or chat support by a psychologist did not enhance the effectiveness of Featback. Support by an expert patient (someone with a lived experience of an ED) might be more effective, since that person can effectively model healthy behavior and enhance self-efficacy in individuals struggling with an ED. The present study aims to replicate and build on earlier findings by further investigating the (cost-)effectiveness of Featback and the added value of expert-patient support.MethodsThe study will be a randomized controlled trial with a two-by-two factorial design with repeated measures. The four conditions will be (1) Featback, in which participants receive automated feedback on a short monitoring questionnaire weekly, (2) Featback with weekly e-mail or chat support from an expert patient, (3) weekly support from an expert patient, and (4) a waiting list. Participants who are 16 years or older and have at least mild self-reported ED symptoms receive a baseline measure. Subsequently, they are randomized to one of the four conditions for 8 weeks. Participants will be assessed again post-intervention and at 3, 6, 9, and 12 months follow-up. The primary outcome measure will be ED psychopathology. Secondary outcome measures are experienced social support, self-efficacy, symptoms of anxiety and depression, user satisfaction, intervention usage, and help-seeking attitudes and behaviors.DiscussionThe current study is the first to investigate e-mental health in combination with expert-patient support for EDs and will add to the optimization of the delivery of Internet-based interventions and expert-patient support.Trial registrationNetherlands Trial Register, NTR7065 . Registered on 7 June 2018.
| S-EPMC6697984 | biostudies-literature
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.
| S-EPMC4628388 | biostudies-literature
Project description:IntroductionEmotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility, and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2-TREpS (Portuguese acronym for Emotion Regulation training for sexual health) project are as follows: (a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction and (b) explore the effects of the intervention on (1) emotion regulation skills, (2) mental health, and (3) sexual self-perception.Methods and analysisThe study will use a randomized controlled trial design. Eligible participants will be randomly allocated to one of two groups: intervention (Internet-based emotion regulation training) or waitlist control. Assessments will take place before the start of the trial, at the end of the trial, and at 6-month follow up, after which participants assigned to the waitlist control condition will receive the same intervention. Primary outcomes include sexual function and satisfaction and secondary outcomes self-report measures of depression, anxiety, difficulties in emotion regulation, and sexual self-perception. This intervention study is financed by the Luxembourg National Research Fund (FNS).Ethics and disseminationEthics approval was obtained from the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.
| S-EPMC8518194 | biostudies-literature
Project description:BackgroundProblem drinking causes great harm to the person and to society. Most problem drinkers will never seek treatment. The current trial will test the efficacy of two Internet interventions for problem drinking - one minimal and the other extended - as an alternate means of providing help to those in need.Methods/designA double blinded, four-wave panel design with random assignment to two experimental conditions will be used in this study. Participants will be recruited through a comprehensive recruitment strategy consisting of online and print advertisements asking for people who are 'interested in helping us develop and evaluate Internet-based interventions for problem drinkers.' Potential participants will be screened to select problem drinkers who have home access to the Internet. Participants will be sent to a password-protected Internet site and, upon signing in, will be randomized to be provided access to the minimal or extended Internet-based intervention. Six-month, twelve-month, and two-year drinking outcomes will be compared between experimental conditions. The primary hypothesis is that participants in the extended Internet intervention condition will display significantly improved drinking outcomes at twelve months compared to participants in the minimal intervention.DiscussionThe findings of this trial will contribute to the growing literature on Internet interventions for problem drinkers. In addition, findings from this trial will contribute to the scarce literature available evaluating the long-term efficacy of brief interventions for alcohol problems.Trial registrationClinical Trials.gov # NCT01874509; First submitted June 17, 2013.
| S-EPMC4308920 | biostudies-literature
Project description:BackgroundEvidence shows that internet-based self-help interventions are effective in reducing symptoms for a wide range of mental disorders. To date, online interventions treating psychotic disorders have been scarce, even though psychosis is among the most burdensome disorders worldwide. Furthermore, the implementation of cognitive-behavioral therapy (CBT) for psychosis in routine health care is challenging. Internet-based interventions could narrow this treatment gap. Thus, a comprehensive CBT-based online self-help intervention for people with psychosis has been developed. The aim of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting list control group.MethodsThe intervention includes modules on delusion, voice hearing, social competence, mindfulness, and seven other domains. Participants are guided through the program by a personal moderator. Usage can be amended by an optional smartphone app. In this randomized controlled trial, participants are allocated to a waiting list or an intervention of eight weeks. Change in positive psychotic symptoms of both groups will be compared (primary outcome) and predictors of treatment effects will be assessed.DiscussionTo our knowledge, this project is one of the first large-scale investigations of an internet-based intervention for people with psychosis. It may thus be a further step to broaden treatment options for people suffering from this disorder.Trial registrationNCT02974400 (clinicaltrials.gov), date of registration: November 28th 2016.
| S-EPMC5899332 | biostudies-literature