Efficacy and Concurrent Validity of Computerized Brain Training Based on Everyday Living (BTEL) Based on Instrumental Activities of Living for Cognitively Healthy Old Individuals: A Preliminary Study.

Background: Interventions to prevent or attenuate cognitive decline and dementia in older adults are becoming increasingly important. Recently, cognitive training exercise can be via computer or mobile technology for independent or home use. Recent meta-analysis has reported that Computerized Cognitive Training (CCT) is effective at enhancing cognitive function in healthy older and Alzheimer's disease adults, although little is known about individual characteristics of each computerized program. Objective: We developed a new CCT named Brain Training Based on Everyday Living (BTEL) to enhance cognitive capacity for Instrumental Activities of Daily Living (IADL). We aim to evaluate the efficacy of the BTEL among cognitively healthy old individuals and to explore its concurrent validity and construct concept. Methods: We conducted a double-blind study where 106 individuals aged 65 years and older (intervened = 53, control = 53) worked on the active and placebo tasks three times a week over three months (clinical trial: UMIN000048730). The main results were examined using ANCOVA and calculating correlation coefficients. Results: We found no effect on total score of the three tests; however, there was significant effect for the BTEL on: recognition in MMSE, and immediate recall in HDSR. The tasks are associated with prefrontal cortex. In addition, correlations indicated that each BTEL domain had some validity as a cognitive assessment tool. Different from previous CCT, we determined the neuropsychological characteristics of specific cognitive tasks of the BTEL to a certain degree. Conclusions: We found modest efficacy of the BTEL in cognitively healthy old individuals and confirmed its concurrent validity and the conceptual construct.

Computerized cognitive control training to reduce rumination in major depression: A randomized controlled trial.

OBJECTIVE: Rumination is a major risk factor for the onset and recurrence of depressive episodes and has been associated with deficits in updating working memory content. This randomized controlled trial examines whether training updating-specific cognitive control processes reduces daily ruminative thoughts in clinically depressed individuals. METHODS: Sixty-five individuals with a current major depressive episode were randomized to 10 sessions of either cognitive control training (N = 31) or placebo training (N = 34). The frequency and negativity of individuals' daily ruminative thoughts were assessed for seven days before training, after training, and at a 3-month follow-up using experience sampling methodology. Secondary outcomes were depressive symptoms, depressed mood, and level of disability. RESULTS: Cognitive control training led to stronger improvements in the trained task than placebo training. However, cognitive control training did not lead to greater reductions in the frequency or negativity of daily ruminative thoughts than placebo training. There were no training-specific effects on participants' depressive symptoms or level of disability. CONCLUSIONS: The robustness of the present null-findings, combined with the methodological strengths of the study, suggest that training currently depressed individuals to update emotional content in working memory does not affect the frequency or negativity of their daily ruminative thoughts.

The therapy relationship, digital interventions, and their interaction.

This article serves as an introduction to a special section devoted to the psychotherapy relationship and digital interventions. The nature of the therapy relationship is explored, and the question is raised as to whether machines can have relationships with their users. Finally, an overview and synthesis of the articles in the special section is provided.

Immersive virtual reality in the treatment of auditory hallucinations: A PRISMA scoping review.

BACKGROUND: A large group of psychiatric patients suffer from auditory hallucinations (AH) despite relevant treatment regimens. In mental health populations, AH tend to be verbal (AVH) and the content critical or abusive. Trials employing immersive virtual reality (VR) to treat mental health disorders are emerging. OBJECTIVE: The aim of this scoping review is to provide an overview of clinical trials utilizing VR in the treatment of AH and to document knowledge gaps in the literature. METHODS: PubMed, Cochrane Library, and Embase were searched for studies reporting on the use of VR to target AH. RESULTS: 16 papers were included in this PRISMA scoping review (ScR). In most studies VR therapy (VRT) was employed to ameliorate treatment resistant AVH in schizophrenia spectrum disorders. Only two studies included patients with a diagnosis of affective disorders. The VRT was carried out with the use of an avatar to represent the patient's most dominant voice. DISCUSSION: The research field employing VR to treat AH is promising but still in its infancy. Results from larger randomized clinical trials are needed to establish substantial evidence of therapy effectiveness. Additionally, the knowledge base would benefit from more profound qualitative data exploring views of patients and therapists.

Does Including Facebook Training Improve the Effectiveness of Computerized Cognitive Training? A Randomized Controlled Trial.

OBJECTIVE: To determine whether implementing a Facebook training program improves the effectiveness of computerized cognitive training (CCT) in older adults. DESIGN: Randomized, controlled, double single-blind trial with parallel groups. SETTING: Community centers. SUBJECTS: Eighty-six adults between 60 and 90 years old. INTERVENTIONS: Nine face-to-face 60-min sessions of CCT with VIRTRAEL for all participants. The experimental group received an additional 30 min of Facebook training per session. MAIN MEASURES: Attention (d2 Test of Attention); learning and verbal memory (Hopkins Verbal Learning Test-Revised); working memory (Letter-Number Sequencing test), semantic and abstract reasoning (Similarities and Matrix Reasoning tests); and planning (Key Search test). RESULTS: There was a significant Group*Time interaction in the Hopkins Verbal Learning Test-Revised-Trial 3, Letter-Number sequencing, and Matrix tests. Between groups, post-hoc analyses showed a difference in Matrix reasoning (p < .001; d = 0.893) at post-intervention in favor of the experimental group. Significant main effects of time were found in the CCT group between baseline and 3-month follow-up for Concentration (F = 26.431, p ≤ .001), Letters and Numbers (F = 30.549, p ≤ .001), Learning (F = 38.678, p ≤ .001), Similarities (F = 69.885, p ≤ .001), Matrix (F = 90.342, p ≤ .001), and Key Search (F = 7.904, p = .006) tests. CONCLUSIONS: The utilization of CCT with VIRTRAEL, a freely accessible tool with broad applicability, resulted in enhanced attention, verbal learning, working memory, abstract and semantic reasoning, and planning among older adults. These improvements were sustained for at least three months post-training. Additional training in Facebook did not enhance the effectiveness of CCT.

Efficacy and acceptability of a self-guided internet-delivered cognitive-behavioral educational program for obsessive-compulsive symptoms with international recruitment.

Cognitive-behavioural therapy is an effective treatment for obsessive-compulsive disorder (OCD). However, there are many barriers in accessing this treatment, with stigma being a particularly prominent barrier for many patients. Self-guided internet-delivered cognitive-behavioural therapy (ICBT), which does not require any contact with a therapist, has the potential to overcome this barrier. However, there is limited research on the efficacy of self-guided ICBT for OCD. The aim of the current study was to examine the efficacy of self-guided ICBT for OCD in a large international sample. Two hundred and sixteen participants were included in the study (Mage = 34.00; SD = 12.57; 72.7% female). On the primary outcome measure, the Yale-Brown Obsessive-Compulsive Scale (YBOCS), a medium within-group effect size was found from pre-treatment to post-treatment (g = 0.63), and a large within-group effect size was found from pre-treatment to 3-month follow-up (g = 0.98). Approximately one-quarter to one-third of participants met criteria for clinically significant improvement at post-treatment and 3-month follow-up (11% and 17% met criteria for remission at post-treatment and 3-month follow-up, respectively). These results demonstrate that self-guided ICBT may be an efficacious treatment for individuals with OCD who cannot or do not wish to engage with a mental health professional, resulting in medium to large effect sizes.

Predictors and Moderators of Treatment Outcomes for Anxious Children Randomized to Computer-Assisted Cognitive Behavioral Therapy or Standard Community Care.

Introduction: Computer-assisted cognitive behavioral therapy (CCBT) for childhood anxiety disorders may aid the dissemination of CBT, while maintaining treatment fidelity. Although CCBT is an effective intervention, not everyone benefits equally from treatment. Identifying patient characteristics that predict who will benefit from treatment and to what extent can help with matching patients to suitable interventions, and allow researchers and clinicians to modify, and individualize, their treatment formats more effectively. Such predictors and moderators have not yet been examined for CCBT outcomes in anxious children and studies of more traditional treatment formats have yielded inconsistent results. Methods: Using data from a randomized clinical trial evaluating CCBT for children with anxiety disorders, this study examined predictors and moderators of treatment outcomes in a sample of 100 children (age: mean [M] = 9.82, standard deviation [SD] = 1.82), randomized to either CCBT (n = 49) or standard community care (n = 51). Potential predictors and moderators were identified from the literature and examined in stepwise multiple linear regression models, using posttreatment anxiety severity and global impairment as outcomes. Results: Parent-rated internalizing symptoms predicted posttreatment anxiety severity for both treatment groups. High pretreatment levels of anxiety severity predicted higher global impairment at posttreatment for the group receiving community care, but not for the CCBT group. Conclusion: Further research is needed to clarify which patient characteristics are associated with CCBT outcomes in a consistent way. ClinicalTrials.gov identifier: NCT01416805.

Safety and function of programmable ventriculo-peritoneal shunt valves: An in vitro 7 Tesla magnetic resonance imaging study.

OBJECTIVE: The quantity of ultra-high field MRI neuroimaging studies has rapidly increased. This study tests function, safety, and image artifacts of two frequently implanted programmable ventriculo-peritoneal (VP) shunt valves in a 7T MRI system. METHODS: All tests were performed using a whole-body 7T MRI system. Three proGAV 2.0 and 3 CODMAN CERTAS® Plus programmable VP-shunt valves were tested in three steps. 1) Deflection angle tests close to the bore opening at the location of a static magnetic field gradient of 3-5 T/m. 2) Valves were fixed on a spherical phantom in 3 positions (a. lateral, b. cranial, c. cranial with 22.5° tilt anteriorly) and assessed for keeping the programmed pressure setting and reprogrammability. 3) Valves were fixed on the phantom and positioned lateral in a radiofrequency head coil. MRI scans were performed for both models, including MPRAGE, GRE and SE sequences. RESULTS: Deflection angles were moderate (13°, 14°, 13°) for the proGAV valves and close to critical (43°, 43°, 41°) for the CODMAN valves at the test location. Taking a scaling factor of 2-3 for the maximum spatial magnetic field gradient accessible to a patient within the magnet bore into account renders both valves MR unsafe regarding ferromagnetic attraction. The proGAV valves kept the pressure settings in all positions and were reprogrammable in positions a. and b. In position c., reprogrammability was lost. The CODMAN valves changed their pressure setting and reprogrammability was lost in all positions. MR image signal homogeneity was unaltered in the phantom center, artifacts limit the assessability of structures in close vicinity to the valves. CONCLUSION: Both tested programmable VP-shunt valves are MR unsafe for 7T systems. Novel programming mechanisms using permanent magnets with sufficient magnetic coercivity or magnet-free mechanisms may allow the development of programmable VP-shunt valves that are conditional for 7T MR systems.

[Short-term efficacy of digitally-assisted traditional Chinese medicine manual reduction combined with 3D printed splint in the treatment of AO type-A distal radius fractures].

Objective To explore the short-term efficacy of digitally-assisted traditional Chinese medicine manual reduction combined with 3D printed splint in the treatment of AO type-A distal radius fractures, and explore the quantification of traditional Chinese medicine manual reduction and personalized improvement of splinting. Methods The clinical data of 50 patients with AO type-A distal radius fractures, who received treatment at the outpatient department of Cangzhou Integrated Traditional Chinese and Western Medicine Hospital in Hebei Province, were retrospective analyzed. The patient cohort included 22 females and 28 males, with ages ranging from 25 to 75 years old. Among them, 27 cases presented with distal radius fractures on the left side, and 24 cases on the right side. The patients were categorized into two groups: treatment group (n=25) and control group(n=25). There were 13 males and 12 females in the treatment group, with an average age of (56.2±5.5) years old. Treatment approach for this group involved several steps. Initially, Mimics Research software was used to conduct comprehensive analysis of complete CT data from the affected limb, resulting in the creation of a three-dimensional model. Subsequently, 3D models of the bones and skin contours, stored as STL format files, were imported into the Materialise Magics 23.0 software for model processing and repair. This facilitated the simulation of reduction and recording of displacement data, effectively generating a "digital prescription" to guide and quantify traditional Chinese medicine manipulation procedures. Finally, a personalized 3D printed splint was applied for fixation treatment. There were 15 males and 10 females in the control group, with an average age of (53.32±5.28) years old. These patients were treated with manualreduction combined with traditional splinting. The clinical efficacy of the two groups was assessed in terms of fracture reduction quality, fracture healing time, Gartland-Werley wrist joint score and X-ray parameters (palminclination angle, ulnar deviation angle, radius height) at 6 weeks post-operatively. Results The treatment group exhibited a shorter duration for achieving clinical healing compared to the control group (P<0.05). Six weeks post-operatively, the treatment group demonstrated higher wrist joint function scores, and a higher proportion of excellent and good outcomes than the control group(P<0.05). The treatment group was superior to the control group in terms of imaging parameters 6 weeks post-operatively (P<0.05). Conclusion By quantifying skin contours through digital simulation prescription reduction, a personalized 3D printed splint is developed to effectively stabilize fractures, enhancing localized fixation while ensuring greater adherence, stability, and comfort. This innovative approach offers personalized treatment for AO type-A distal radius fractures and presents a novel, precise treatment strategy for consideration.

Examining outcomes for service users accessing the Breaking Free Online computer-assisted therapy program for substance use disorders via a 'telehealth' approach: protocol for a two arm, parallel group randomized controlled trial.

BACKGROUND: Breaking Free Online (BFO), a computer-assisted therapy (CAT) program for substance use disorders (SUD), has been available across UK treatment services for the past decade and has demonstrated efficacy. The Covid-19 pandemic has contributed to digital and 'telehealth' approaches to healthcare delivery becoming more common and accepted, and has in parallel, increased numbers of referrals to SUD services because of the impact pandemic-related stress has had on substance using habits in the general population. Digital and telehealth approaches, such as BFO, have the potential to support the treatment system to meet this increased demand for SUD services. METHODS: Parallel-group randomized controlled trial of eight-week BFO as an adjunct to standard treatment for SUD, in comparison to standard treatment only, at a National Health Service (NHS) Mental Health Trust in North-West England. Participants will be service users aged 18 years and over with demonstrable SUD for at least 12-months. Interventional and control groups will be compared on multiple measures from baseline to post-treatment assessment at eight-weeks, and then three and six-months follow-up. Primary outcome will be self-reported substance use, with secondary outcomes being standardized assessments of substance dependence, mental health, biopsychosocial functioning and quality of life. DISCUSSION: This study will examine whether BFO and telehealth support, when delivered as an adjunct to standard SUD interventions, improves outcomes for services users receiving NHS SUD treatment. Findings from the study will be used to inform both developments to the BFO program and guidance around augmenting the delivery of CAT programs via telehealth. Trial registration registered with ISRCTN on 25th May 2021-registration number: 13694016. PROTOCOL VERSION: 3.0 05th April 2022. TRIAL STATUS: This trial is currently open to recruitment-estimated to be completed in May 2023.

Online cognitive behavioral therapy for prolonged grief after traumatic loss: a randomized waitlist-controlled trial.

Prolonged grief disorder, a condition characterized by severe, persistent, and disabling grief, is newly included in ICD-11 and DSM-5-TR. Prolonged grief symptoms can be effectively treated with face-to-face or internet-delivered cognitive behavioral therapy. Traumatic losses may elicit higher prevalence of severe grief reactions. While face-to-face cognitive behavioral therapy appears efficacious in treating prolonged grief symptoms in traumatically bereaved individuals, it is not yet clear if internet-based cognitive behavioral therapy is efficacious for this population. Therefore, we investigated the efficacy of a 12-week internet-delivered cognitive behavioral therapy for people bereaved through traffic accidents in a randomized waitlist-controlled trial (registration number: NL7497, Dutch Trial Register). Forty adults bereaved though a traffic accident were randomized to internet-based cognitive behavioral therapy (n = 19) or a waitlist control condition (n = 21). Prolonged grief, post-traumatic stress, and depression symptoms were assessed at baseline, post-treatment, and 8-week follow-up. Dropout in the treatment condition was relatively high (42%) compared to the control condition (19%). Nevertheless, multilevel analyses showed that internet-based cognitive behavioral therapy strongly reduced prolonged grief, post-traumatic stress, and depression symptoms relative to the control condition at post-treatment and follow-up. We conclude that internet-based cognitive behavioral therapy appears a promising treatment for traumatically bereaved adults.

Improving adherence to unguided Internet-based therapy for obsessive-compulsive disorder: A randomized controlled trial.

BACKGROUND: Adherence to internet-based cognitive-behavioral therapy (iCBT) is often low, possibly reducing its potential. The current study set out to test whether adherence and effects of unguided iCBT for obsessive-compulsive disorder (OCD) could be improved by varying the degree of autonomy in which modules are completed (free choice vs. fixed order). METHODS: We randomized 151 individuals with OCD to either an unguided iCBT with a fixed (iCBTfixed) or a free-choice (iCBTfree+) order of the modules. We assessed participants at baseline (t0), eight weeks (t1), and 16 weeks (t2). Primary outcomes were adherence (utilization time, modules completed) and change in OCD severity (Y-BOCS). Secondary outcomes included depression, self-esteem, and treatment satisfaction. We calculated intent-to-treat (ITT) and complete case (CC) analyses. RESULTS: Analyses showed that both iCBT programs significantly reduced OCD severity. While groups did not differ on the ITT analyses, for the CC analyses, a greater improvement was found in the iCBTfixed in comparison to the iCBTfree+ group regarding OCD severity and quality of life, with medium effect sizes from t0 to t1 (ηp2 = 0.067-0.077). Time of utilization and number of modules completed did not differ between groups. LIMITATIONS: No placebo control group, short follow-up period, self-report assessment. CONCLUSIONS: iCBT is effective in improving OCD. Despite similar adherence in the fixed versus the free-choice module order, the study offers tentative evidence that a fixed order of content is associated with better effects. More research on the effects of adherence on outcome is necessary.

An Unguided, Computerized Cognitive Behavioral Therapy Intervention (TreadWill) in a Lower Middle-Income Country: Pragmatic Randomized Controlled Trial.

BACKGROUND: Globally, most individuals who are susceptible to depression do not receive adequate or timely treatment. Unguided computerized cognitive behavioral therapy (cCBT) has the potential to bridge this treatment gap. However, the real-world effectiveness of unguided cCBT interventions, particularly in low- and middle-income countries (LMICs), remains inconclusive. OBJECTIVE: In this study, we aimed to report the design and development of a new unguided cCBT-based multicomponent intervention, TreadWill, and its pragmatic evaluation. TreadWill was designed to be fully automated, engaging, easy to use, and accessible to LMICs. METHODS: To evaluate the effectiveness of TreadWill and the engagement level, we performed a double-blind, fully remote, and randomized controlled trial with 598 participants in India and analyzed the data using a completer's analysis. RESULTS: The users who completed at least half of the modules in TreadWill showed significant reduction in depression-related (P=.04) and anxiety-related (P=.02) symptoms compared with the waitlist control. Compared with a plain-text version with the same therapeutic content, the full-featured version of TreadWill showed significantly higher engagement (P=.01). CONCLUSIONS: Our study provides a new resource and evidence for the use of unguided cCBT as a scalable intervention in LMICs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03445598; https://clinicaltrials.gov/ct2/show/NCT03445598.

Digital Therapies (DTx) as New Tools within Physicians' Therapeutic Arsenal: Key Observations to Support their Effective and Responsible Development and Use.

In recent years, there has been a swift rise in the development of digital therapies (DTx). As a result of various technological advances and accessibility to patients, it is now possible to develop and offer therapeutic interventions in a digital manner. These take the form of an evidence-based intervention that is administered in digital form to prevent, manage, or treat a medical condition. What makes DTx significantly different from other types of digital applications or services (e.g., wellness applications) is that they are interventions authorised by regulatory agencies for the treatment, like a drug, of a health condition. Yielding actual therapeutic benefits and being at the crossroads of health and digital means that DTx are subject to both the upsides and downsides of both sectors. Thus, it is of particular interest to look at the facilitators and barriers to be foreseen in the development, assessment, and implementation of DTx. In this article, we will present key observations and outline the main challenges that may be faced in the development and integration of DTx into practice. It is certain that DTx can represent an interesting avenue for physicians to bring their prescribing role into the 21st century. We conclude with broad lessons that the emerging field of DTx can learn from decades of drug industry practice to avoid history repeating itself and to fast-track the development and ethical and optimal use of DTx.

Accuracy of residual respiratory event detection by CPAPs: a meta-analysis.

PURPOSE: Most continuous positive airway pressure (CPAP) machines have built-in manufacturer-specific proprietary algorithms for automatic respiratory event detection (AED) based on very specific respiratory events scoring criteria. With regards to the accuracy of these data from CPAP machines, evidence from the literature seems conflicting, which formed the basis for this meta-analysis. METHODS: A meta-analysis was performed on studies that reported Bland-Altman analysis data on agreement (mean bias and limits of agreement [LoA]) of CPAP-determined apnea-hypopnea index (AHI) at therapeutic pressures (AHIFLOW) with that determined from simultaneously conducted polysomnograms (AHIPSG). RESULTS: In six studies, ResMed CPAPs were used, and in another six studies, Respironics CPAPs were used, while only one study used Fisher & Paykel (F&P) CPAPs. The pooled mean AHI bias from ResMed CPAP studies was - 1.01 with pooled LoAs from - 3.55 to 1.54 (I2 = 17.5%), and from Respironics CPAP studies, pooled mean AHI bias was - 0.59 with pooled LoAs from - 3.22 to 2.05 (I2 = 0%). Pooled percentage errors (corresponding to LoAs) from four ResMed CPAP studies, four Respironics CPAP studies, and the F&P CPAP study were 73%, 59%, and 112%, respectively. A review of the literature for this meta-analysis also revealed lack of uniformity not only in the CPAP manufacturers' respiratory events scoring criteria but also in that used for PSGs across the studies analyzed. CONCLUSIONS: Even though the pooled results of mean AHI bias suggest good clinical agreement between AHIPSG and AHIFLOW, percentage errors calculated in this meta-analysis indicate the possibility of a significant degree of imprecision in the estimation of AHIFLOW by CPAP machines.

Using MRI to measure position and anatomy changes and assess their impact on the accuracy of hyperthermia treatment planning for cervical cancer.

PURPOSE: We studied the differences between planning and treatment position, their impact on the accuracy of hyperthermia treatment planning (HTP) predictions, and the relevance of including true treatment anatomy and position in HTP based on magnetic resonance (MR) images. MATERIALS AND METHODS: All volunteers were scanned with an MR-compatible hyperthermia device, including a filled waterbolus, to replicate the treatment setup. In the planning setup, the volunteers were scanned without the device to reproduce the imaging in the current HTP. First, we used rigid registration to investigate the patient position displacements between the planning and treatment setup. Second, we performed HTP for the planning anatomy at both positions and the treatment mimicking anatomy to study the effects of positioning and anatomy on the quality of the simulated hyperthermia treatment. Treatment quality was evaluated using SAR-based parameters. RESULTS: We found an average displacement of 2 cm between planning and treatment positions. These displacements caused average absolute differences of ∼12% for TC25 and 10.4%-15.9% in THQ. Furthermore, we found that including the accurate treatment position and anatomy in treatment planning led to an improvement of 2% in TC25 and 4.6%-10.6% in THQ. CONCLUSIONS: This study showed that precise patient position and anatomy are relevant since these affect the accuracy of HTP predictions. The major part of improved accuracy is related to implementing the correct position of the patient in the applicator. Hence, our study shows a clear incentive to accurately match the patient position in HTP with the actual treatment.

More than doubling the clinical benefit of each hour of therapist time: a randomised controlled trial of internet cognitive therapy for social anxiety disorder.

BACKGROUND: Cognitive therapy for social anxiety disorder (CT-SAD) is recommended by NICE (2013) as a first-line intervention. Take up in routine services is limited by the need for up to 14 ninety-min face-to-face sessions, some of which are out of the office. An internet-based version of the treatment (iCT-SAD) with remote therapist support may achieve similar outcomes with less therapist time. METHODS: 102 patients with social anxiety disorder were randomised to iCT-SAD, CT-SAD, or waitlist (WAIT) control, each for 14 weeks. WAIT patients were randomised to the treatments after wait. Assessments were at pre-treatment/wait, midtreatment/wait, posttreatment/wait, and follow-ups 3 & 12 months after treatment. The pre-registered (ISRCTN 95 458 747) primary outcome was the social anxiety disorder composite, which combines 6 independent assessor and patient self-report scales of social anxiety. Secondary outcomes included disability, general anxiety, depression and a behaviour test. RESULTS: CT-SAD and iCT-SAD were both superior to WAIT on all measures. iCT-SAD did not differ from CT-SAD on the primary outcome at post-treatment or follow-up. Total therapist time in iCT-SAD was 6.45 h. CT-SAD required 15.8 h for the same reduction in social anxiety. Mediation analysis indicated that change in process variables specified in cognitive models accounted for 60% of the improvements associated with either treatment. Unlike the primary outcome, there was a significant but small difference in favour of CT-SAD on the behaviour test. CONCLUSIONS: When compared to conventional face-to-face therapy, iCT-SAD can more than double the amount of symptom change associated with each therapist hour.

Efficacy of a transdiagnostic guided internet-delivered intervention for emotional, trauma and stress-related disorders in Mexican population: study protocol for a randomized controlled trial.

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.