Clinical trials

This adaptive randomized controlled trial evaluates the efficacy of a transdiagnostic, internet-delivered psychological intervention for emotional disorders, tailored to patient´s early clinical response. 366 adults with clinically significant symptoms of depression and/or anxiety will begin a 12 module self-applied program. Based on sympton reduction after the first three modules, participants will be classified as early or late responders and randomized into different experimental arms. The main hypothesis is that a hybrid format (self-applied modules plus synchronous sessions with a therapist) will yield better outcomes for late responders. Outcomes include symptom reduction, emotional regulation and internet based therapheutic alliance.

This study will consist in a randomized controlled clinical trial (RCT) to test the efficacy of a blended group transversal protocol (BLGr-TP) compared to a face-to-face group transversal protocol (FFGr-TP). The main aims of the study are the following: * To analyze the differential efficacy of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders in aspects of clinical measures, as well as in terms of retention and dropout rate and adherence. * To analyze the differential acceptability of the BLGr-TP versus the FFGr-TP for the treatment of emotional disorders. In addition, it is intended to carry out a study of mediators and moderators of the efficacy of both interventions. The established hypotheses in relation to the main goals are: * Both treatment modalities (FFGr-TP and BLGr-TP) will achieve improvements in the symptoms of emotional disorders, reflected in the scores of the clinical measures. * The BLGr-TP will show equivalent efficacy to the FFGr-TP. * The BLGr-TP will show an acceptability comparable to the face-to-face protocol. Both modalities will be well valued by the participants. * In both treatment modalities, the changes achieved are expected to be maintained over time (3, 6 and 12 months).

This study aims to examine whether short bouts of exercise (10 minutes) performed during the school day can improve thinking skills, creativity and emotional wellbeing in primary school children. Specifically, children aged 11-12 years will be randomly assigned to perform either a short aerobic exercise break, a strength-based exercise break, or a seated control activity. The study will evaluate how these 10 minutes activity breaks influence attention, working memory, creativity, and emotional wellbeing state after completing cognitively demanding tasks. The findings will help to identify effective strategies to integrate physical activity into the classroom to enhance learning and overall well-being in school settings.

Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.

This multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain in primary care. The intervention combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits to improve health-related quality of life in adults with persistent nonspecific musculoskeletal pain lasting at least six months. A total of 146 participants aged 18 to 70 years will be recruited from five primary care centers in the Comunitat Valenciana (Spain) and randomly assigned to either the experimental group or the control group. The primary outcome is health-related quality of life measured using the SF-36 Health Survey. Secondary outcomes include pain intensity, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication use, and lifestyle-related variables. Assessments will be conducted at baseline, post-intervention, 6 months, and 12 months follow-up.

The main aim of this project is to test the efficacy of two formats of delivering an internet- based treatment(GROw) for Prolonged Grief Disorder (PGD) in order to enhance treatment adherence: in a blended format (that combines self-applied treatment online with face-to face sessions with a therapist by videoconference: BF-GROw) and self-applied online format supported by Ecological Momentary Assessment (EMAs) and Ecological Momentary Interventions (EMIs) (iGROw), compared with a waiting list (WL) control group in a community sample of patients with the diagnosis of PGD. The general initial hypothesis is that both treatment conditions (blended format and self-applied format supported by EMAs and EMIs) will significantly produce an improvement in grief symptoms, compared to the WL control group.

This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care. The study will be conducted in four Primary Care physiotherapy units in the Valencian Community (Spain). A total of at least 68 participants aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited. The intervention will consist of a structured multimodal physiotherapy program including educational sessions on pain neuroscience and guided therapeutic exercise. The main outcome will be health-related quality of life, assessed using the SF-36 Health Survey. Secondary outcomes will include pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale for Kinesiophobia), and central sensitization (Central Sensitization Inventory), among others. Data will be collected using the REDCap electronic platform at three time points: baseline (pre-intervention), immediately after the intervention, and six months post-intervention. Statistical analysis will include descriptive statistics, bivariate analyses, and paired comparisons to assess changes over time. The study seeks to generate evidence on the feasibility and potential effectiveness of implementing a multimodal physiotherapy intervention for active coping with chronic musculoskeletal pain in the context of Primary Care.

Background Chronic musculoskeletal pain, especially chronic low back pain (CLBP), is the leading cause of disability worldwide, with a burden expected to rise due to aging and increased longevity. Despite strong evidence supporting multimodal and non-pharmacological management-particularly active physical therapy and self-management-clinical practice still shows low adherence to guidelines, with excessive reliance on imaging, rest, injections, and surgery. Adherence to physical therapy remains one of the most significant barriers: only 40-50% of patients follow prescribed exercise programs. Factors include kinesiophobia, low motivation, and logistical obstacles. Mixed realities (XR: VR, AR, MR) offer solutions by enhancing motivation, reducing barriers, and personalizing rehabilitation. Evidence from systematic reviews shows VR-based rehabilitation can reduce pain, disability, and kinesiophobia, with immersive VR offering additional benefits like presence and habit-building. The SHARESPACE project developed and tested a novel XR rehabilitation environment for CLBP that integrates immersive VR/AR, tele-rehabilitation, real-time motor tracking, avatars for social support, and cognitive architectures for synchronization. Usability studies with patients, clinicians, and the general population confirm its feasibility and acceptance. SHARESPACE has completed phases 1 and 2 of XR intervention development (design and feasibility), now aiming to move to phase 3: large-scale clinical validation. Objectives The main goal is to evaluate not only short-term efficacy but long-term, as well as including more accurate and objective measures. A second objective is the commercial exploitation WE will valuate the efficacy, adherence, and cost-effectiveness of the SHARESPACE XR rehabilitation system compared to usual care in patients with CLBP. Specific objectives include: 1. To conduct a two-site randomized controlled trial (RCT) comparing XR rehabilitation with conventional group rehabilitation. 2. To assess both short-term and long-term outcomes (pain intensity, disability, kinesiophobia). 3. To monitor and improve adherence through ecological momentary assessment and intervention (EMA/EMI) using an app and activity trackers. 4. To enhance motivation and engagement with gamification, social connectedness, and avatar-based interaction. 5. To generate evidence for commercial exploitation and integration into health systems. Methodology The project will conduct a two-site RCT with CLBP patients. Participants will be randomly allocated to: * XR rehabilitation: * Two hospital sessions (traditional + XR-assisted training). * Four remote XR sessions with therapist and patients (L1 avatars). * Continued home-based XR with automated therapist avatars (L3) for up to 120 days. * Integration of EMA/EMI via an app and wearable devices to monitor daily activity, sleep, and adherence, with automated prompts to encourage compliance. * Usual care: standard group rehabilitation sessions for 8 weeks. Primary outcomes: * Pain intensity (VAS, BPI). * Disability (Oswestry Disability Index). * Kinesiophobia (Tampa Scale of Kinesiophobia). Secondary outcomes: adherence rates, motivation, patient satisfaction, feasibility, and cost-effectiveness. Motor performance data will be captured in real time via XR tracking and transmitted to therapists for feedback.

The project aims to assess the feasibility of self-administered training for individuals with public speaking anxiety, specifically targeting the reduction of emotional reasoning bias. It seeks to evaluate the interventions' usability, acceptability, satisfaction and adherence/compliance rates. In addition, the study intends to determine the feasibility of conducting a potential randomised clinical trial to evaluate the true impact of the intervention on emotional reasoning biases and public speaking anxiety levels.

The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are: 1. Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures. 2. The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods. 3. Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE. 4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Teaching using VR for basic cardiopulmonary resuscitation and patient examination (experimental group) will not result in differences in knowledge and skill acquisition compared to traditional classroom-based simulation teaching (control group), but it will lead to greater satisfaction and self-confidence. Open, single-center randomized clinical trial involving fourth-year nursing degree students at a public university. Participants will be assigned based on their usual teaching groups (ratio of 6-8 students per instructor) and, according to randomization, will receive a 1:1 assignment to either the control group (classroom-based simulation teaching) or the experimental group (classroom-based simulation teaching combined with VR headset teaching). The CONSORT checklist will be followed to report the study.

The present research project is framed within the issue of Borderline Personality Disorder (BPD). This condition stands as one of the most common challenges encountered within the mental health services of the National Health System. The primary objectives of this research are to verify whether the combined use of established treatments for patients and their families, conducted in parallel, leads to a greater improvement in patients and their families, respectively. Additionally, another aim of the project is to assess efficiency, defined as the acceptance of intervention programs by patients, their families, and clinical professionals, as well as to demonstrate their feasibility.

The study aims to develop and implement a self-applied online psychological intervention for the correction of Emotional Reasoning bias for people with public speaking anxiety. By comparing the effects of this training for ER biases vs. a non-specific mindfulness intervention, the newly developed intervention is expected to promote a greater reduction in emotional reasoning bias and the severity of symptomatology associated with public speaking anxiety.

The main aim of this study is to validate and test the clinical effectiveness of the projection-based augmented reality system in cockroach phobia exposure therapy through an RCT that includes three conditions: (i) projection-based augmented reality therapy, (ii) usual treatment (in vivo exposure), (iii) waiting list control. In addition, it is intended to analyze the potential of the eye-tracking technology as a tool for evaluating the clinical effectiveness in cockroach phobia treatment.