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Feedback, Psychological clinical trials

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NCT ID: NCT06356961 Not yet recruiting - Clinical trials for Feedback, Psychological

Routine Outcome Monitoring and Feedback Informed Therapy in Italy

FIT-ITALY
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy. The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan. Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following: I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy. Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/). Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.

NCT ID: NCT06207773 Recruiting - Self Efficacy Clinical Trials

The Effect of Verbal Feedback Given by the Educator

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Purpose of the research; To examine the effect of verbal feedback given by the educator on nursing students' clinical competence, academic self-efficacy and perceived stress levels. Hypotheses of the research; H1: Nursing students' academic self-efficacy level increases after the intervention. H2: Nursing students' clinical self-efficacy level increases after the intervention. H3: The level of stress perceived by nursing students decreases after the intervention.

NCT ID: NCT05893953 Completed - Clinical trials for Feedback, Psychological

Spine Angle Comparison in Adult Seating Posture With Immediate Feedback

Start date: November 20, 2017
Phase: N/A
Study type: Interventional

1. Background: In modern society, people are spending more time sitting due to the increased use of IT devices. Prolonged sitting with incorrect posture can lead to spinal deformities and an increase in spinal diseases. Common deformities include turtle neck posture, flat back, straight neck, and bent back. Misalignment of the spine is considered an important factor in causing spinal diseases, such as pain, arthritis, and degeneration. To address these issues, researchers have developed pillows and chairs that are ergonomically designed for everyday use and have been found to be effective. 2. Purpose: This study aims to investigate whether portable equipment can help individuals recognize and maintain correct sitting posture on their own. 3. Design: This study has a cross-sectional study design. Each condition is divided into three different sitting conditions. By using post-evaluation data, the intention is to compare the effects. (Condition A: sitting on a standard chair wearing an immediately feedback device, Condition B: sitting on a gym-ball, Condition C: sitting on standard chair) 4. Subject : Twenty-eight subjects were recruited as healthy students attending S University located in Nowon-gu, Seoul. 5. Result: The study found that maintaining a sitting posture immediately resulted in a statistically significant lower angle over time at the Cervicothoracic angle compared to other interventions. Similarly, a sitting posture immediately maintained a lower angle over time at the Thoracic angle compared to other sitting postures . However, the lumbar angle showed a significant increase over time.

NCT ID: NCT05696353 Recruiting - Communication Clinical Trials

Teen Driving Translation Study (NIH)

Start date: November 17, 2022
Phase: Phase 3
Study type: Interventional

To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

NCT ID: NCT05376072 Completed - Clinical trials for Feedback, Psychological

Electromyographic Biofeedback Muscle Recovery Meniscectomy

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Electromyographic biofeedback (EMG-BF) is a therapeutic technique that has been used success-fully in rehabilitation of injuries. Although it has been applied in athletes, its use in this field is not very widespread. The objective of this study is to analyze its effectiveness in the recovery of electromyographic activity of the quadriceps after meniscectomy, evaluated through isometric contraction of the vastus lateralis. The sample comprised ten professional footballers in the Spanish League (2nd Division A) who had previously suffered a meniscus injury in their knee and had undergone a meniscectomy. The intervention consisted of EMG-BF treatment lasting between 6 and 10 sessions. The electromyographic signal was recorded using a Thought Tech-nology ProComp Infiniti 8-channel biofeedback unit with a sampling rate of 2048 sam-ples/seconds. For each session a within-subject ABA design of 6 or 10 trials per session was used, with three pre- and three post-measures, which determined the gain for each session.

NCT ID: NCT04592978 Recruiting - Pain Clinical Trials

Personalized Feedback Intervention for Alcohol and Opioid Use Among Adults With Chronic Pain

Start date: July 30, 2021
Phase: N/A
Study type: Interventional

Over one-quarter of American adults engage in hazardous drinking (i.e., a pattern of alcohol consumption that increases risk for harmful consequences), which is the third leading cause of preventable death in the U.S. Rates of hazardous drinking are significantly higher among individuals with (vs. without) chronic pain. Moreover, 20% of individuals prescribed opioids endorse concurrent alcohol and opioid use, which may interfere with chronic pain treatment and lead to dangerous/potentially fatal health effects. No interventions to date have targeted either hazardous drinking or concurrent use of alcohol and opioids in the context of chronic pain. The current four-year R01 builds upon our past work by developing a brief, single-session, computer-based, personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding concurrent use of alcohol and prescription opioid medications. Specifically, we will develop an integrated PFI for hazardous drinkers with chronic pain who are prescribed opioids (PA-PFI). Our approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral interventions. Phase IA activities will involve collecting qualitative and quantitative feedback from three iterative focus groups (N = 21) to refine intervention content and evaluate treatment acceptability and feasibility. Phase IB activities will include a proof-of-concept and highly rigorous randomized clinical trial designed to compare PA-PFI to control PFI (C-PFI) among a sample of 174 hazardous drinkers with chronic pain who are currently prescribed opioid medications. This study represents an important and pivotal step in the larger landscape of translating basic research to more efficacious strategies for reducing hazardous drinking among underserved populations with medical comorbidities. This intervention would be highly disseminable and relevant to millions of hazardous drinkers with chronic pain. Given the collective public health impact of chronic pain, hazardous drinking, and concurrent alcohol-prescription opioid use, we believe the current study will yield findings that enhance scientific knowledge, enhance our understanding of mechanisms in reciprocal pain-alcohol-opioid relations, and inform the development of novel treatments for hazardous drinkers with chronic pain that are adaptable and easily implemented across a variety of healthcare settings.

NCT ID: NCT04460833 Completed - Cerebral Palsy Clinical Trials

Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy

BestOf_ARRoW
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems. Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.

NCT ID: NCT04317664 Recruiting - Communication Clinical Trials

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

projectDRIVE
Start date: September 28, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.

NCT ID: NCT03503487 Completed - Communication Clinical Trials

Surgical Planning and Informed Consent

SPLICE
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

New devices for anatomic studies and 3-D visualization have proven to be useful for pre-operative surgical planning and intra-operative procedures; the hypothesis of our study is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can improve doctor-patient communication during the process of obtaining informed consent: through tridimensional representation of anatomic structures of the brain, these devices are able to help patients understand better their own anatomy and the surgical approach to their disease. The aim of our study is therefore to understand whether this high-technology 3D planning, used as a tool to optimize patient-doctor communication, can effectively improve patients' understanding of the disease and the surgical procedure they will be going through (for which they are supposed to sign the consent), as well as the benefits, the risks and all the possible complications that can derive form surgery. Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical procedure could be customized for each different person, considering that anyone has certain unique individual features that a regular standardized system could not possibly take into account.

NCT ID: NCT03421028 Not yet recruiting - Sleep Clinical Trials

Evaluation of Biofeedback Therapy Efficiency in Masticatory Muscles Pain Management

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study evaluates beneficial effects of biofeedback therapy in reducing pain and increased tension of muscles occurring in patients with temporomandibular disorders (TMD). During the study Electromyography Biofeedback (EMG-Biofeedback)- assisted training lowering muscle tension will be used. The patients will undergo 4 or 8 meetings of EMG-Biofeedback - assisted training Than the patients will be reevaluated after 6 and 12 weeks.