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NCT ID: NCT05803252 Recruiting - Clinical trials for Autism Spectrum Disorder

Videoconferencing-based Focused Acceptance and Commitment Therapy for Parents of SHCN Children

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The purpose of the proposed non-randomized waitlist-controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a Videoconferencing-based Individual Focused Acceptance and Commitment Therapy (FACT) approach to enhance the mental well-being of parents of children with special healthcare needs (SHCN) over a three-month period after the intervention has taken place.

NCT ID: NCT05798299 Recruiting - Clinical trials for Childhood Depression

Efficacy Study of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

UP-C/C
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

The UP-C is a manualized, cognitive-behavioral, and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems (i.e., anxiety and depression) in children aged 7 to 12 years old. This psychological intervention mainly focuses on reducing the intensity and frequency of strong and aversive emotional experiences in children through the development of skills that allow them to face these emotions in a more adaptive way. By targeting the factors common to emotional disorders (avoidance, emotional reactivity, affective intolerance) we believe this intervention might increase the effectiveness of the treatment of these difficulties (mainly in the cases where comorbidity is present). It may also contribute to therapists' expertise when dealing with different emotional disorders, by not requiring the simultaneous mastery of multiple interventions, to a reduction of costs associated with training and to the planning of more individualized and flexible interventions. This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context. Thus, to better adapt to the limitations existent in mental health services in Portugal, a modified version of the UP-C was developed by reducing the number of sessions for parents. The current study seeks to understand whether this adapted version of the UP-C - the UP-C/C - less demanding in terms of resources required for its application, is effective in reducing children's emotional symptomatology and produces changes on maladaptive parenting strategies used by parents. This version is mostly centered on the child, who participates in 15, 90 minutes, group sessions. In this version of the program, the parents adopt the role of "cotherapists", and support homework completion at home by the child. They also have access to psychoeducational material (in video and written format). Additionally, the UP-C/C includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations. This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors. These are the specific objectives of the study: 1. To evaluate the efficacy of the UP-C/C through a Randomized Controlled Clinical Trial with two conditions (UP-C/C and Coping Cat in group format) on the primary outcomes (child's anxiety and depression symptoms, interference of anxiety and depression in the child's school, social and family functioning), secondary (quality of life, emotional expression and cognitive errors), and on the transdiagnostic factors (avoidance, emotional reactivity, affective intolerance) and on the parental variables (parents' emotional behaviors, orientation towards the child's emotions, symptoms of anxiety and depression); 2. To evaluate the involvement of the child and parents in the program (attendance, dropout, active participation) and find out its predictors (age; intensity of symptoms; readiness for change; therapeutic alliance; expectations regarding the intervention). The main hypothesis of the study, relating to the efficacy study, is the following: - UP-C/C is expected to have equivalent results to Group Coping Cat in outcomes related to anxiety and quality of life and superior results in outcomes related to depression and transdiagnostic mechanisms.

NCT ID: NCT05784818 Recruiting - Mental Illness Clinical Trials

Up To Me: Erasing the Stigma of Mental Illness on College Campuses

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

This is a three-lesson, disclosure-based stigma reduction program meant to reduce barriers to community living and participation for college students with psychiatric disabilities. The goal is to improve community living and participation of individuals with psychiatric disabilities within their postsecondary community using the Honest Open Proud (HOP) program. There are 3 specific objectives of the project:1) evaluate program fidelity, 2) assess program feasibility, and 3) conduct a randomized controlled trial of the HOP program with college students with mental illness to examine its efficacy. Anticipated outcomes include increases in 1) community integration, 2)self-esteem and self-efficacy, 3) empowerment and self-determination, 4) disclosure of mental illness in order to obtain needed support, and 5) care seeking/service engagement for mental illness. Ultimately, we expect to see increased academic persistence and achievement among HOP program completers.

NCT ID: NCT05779644 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus

Start date: February 23, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.

NCT ID: NCT05778630 Recruiting - Clinical trials for Multiple Chronic Conditions

Emotions and Cognitions in Pediatric Chronic Physical Conditions

EmCog
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Children living with a chronic physical condition (CPC) are more likely than their peers without a disease to develop psychological difficulties or disorders (Hysing et al., 2007). To prevent or treat these difficulties and disorders, many psychotherapeutic approaches have been developed and tested. Most of them follow a categorical approach, based on a global diagnosis (e.g., Moreira et al., 2013). Few interventions are conducted from a processual perspective (Nef et al., 2012) studying underlying mechanisms of psychological functioning. Emotions and cognitions represent such underlying processes and play an important role in many psychopathological disorders. These processes can weaken but also protect a child from developing psychological difficulties, depending on whether they are effective or not (Gipson et al., 2006; Hysing et al., 2007; Lahaye et al., 2011). The present research project aims to identify a psychological intervention that builds on knowledge of emotional and cognitive processes, considered as protective and risk factors, to prevent/treat psychological difficulties. The project will be conducted in two parts: 1. The first phase aims to better understand the action mechanisms of psychological interventions, focused on emotional and cognitive difficulties of children with CPCs. First, a systematic review will identify recent literature which reports the efficacy of psychological interventions which focused on emotional and cognitive processes. Second, interviews with experts (e.g., pediatricians, psychiatrists, psychologists, nurses, educators) in the field of CPCs and with parents/families of children with CPCs will be conducted. Individual and focus group meetings will be organized, with the aim of identifying the needs of children, based on clinical and practical knowledge and experience. A third phase will consist of the selection of an intervention that will be based on the results of the first two phases. 2. In the second part (not yet registered), the selected intervention will be set up for a feasibility study (Bowen et al., 2009). For this, a small sample of children will participate in the intervention. Participants will be randomly allocated to an intervention group and a control group. The control group will participate in an alternative intervention (e.g., information on chronic diseases). The exact content of the intervention and its form (number of sessions, duration etc.) will be determined by the focus group. The intervention's efficacy will be evaluated (evaluation of emotional and cognitive processes as well as psychological and physiological health), using a mixed method approach. The results will be analyzed and discussed with the focus group. Limitations and perspectives will be formulated to allow for possible transfer of the intervention for future use or to other areas of psychology (Durlak & DuPre, 2008).

NCT ID: NCT05772364 Recruiting - Orthopedic Disorder Clinical Trials

High- Versus Low-calcium Water for Bone Health

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.

NCT ID: NCT05767593 Recruiting - Clinical trials for Major Depressive Disorder

Clinical Validation of Samsung Smartwatch

Start date: March 13, 2023
Phase:
Study type: Observational

Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 75 individuals diagnosed with current Major Depressive Disorder and 75 healthy controls. To meet this target, the recruitment target is set at 215 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.

NCT ID: NCT05766280 Recruiting - Clinical trials for Mental Health Wellness 1

Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth With Mental Health Conditions

iCareer
Start date: June 23, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of an internet- assisted Career-Oriented Work-Related Soft-skills Training (iCareer) intervention, infused with cognitive behavioral therapy, targeting individuals ages 16-24 with mental health conditions, to improve employment outcomes. The overall objective is to help transition-age youth (TAY) with psychiatric disabilities achieve optimal employment outcomes as part of successful transition to adulthood. Findings will have implications for enhancing and developing pre-employment services for TAY with psychiatric disabilities.

NCT ID: NCT05765864 Recruiting - Self-harm Clinical Trials

Self-harm Behaviour Among the Most At-risk Adolescents

SH-MARA
Start date: March 23, 2023
Phase:
Study type: Observational

In the proposed study, three objectives will be pursued: 1. To develop a method to identify more effectively the acute and long-term risk of adolescents with the most threatening self-harm behaviours. 2. To identify the factors that influence the risk of self-harm behaviours and the success of treatment/treatment of these behaviours in the most at-risk adolescents (changes in these factors). 3. Develop guidelines for more effective treatment of the most at-risk adolescents. For this purpose, a sample of approximately 200 young people who will be hospitalised for suicide risk (the most at risk in Slovenia) and an approximately equal number of healthy adolescents will be included. At inclusion, the presence of several factors will be assessed by reviewing demographic data, clinical diagnosis, self-assessment questionnaires and clinical psychological tests (CSSRS, B-NSSI-AT, ISAS, LPFS-BF2.0, BPFSC-11, TSCC, PAI, ECR-RS, DASA-YV, ASHRS), social assessment, and blood sampling for genetic analyses (DNA isolation, sequencing, nucleotide sequence recognition, quantification and evaluation of short tandem repeats, identification of methylation sites). Longitudinal tracking of autoaggressive events and heteroaggressive events during hospitalisation will be performed and recorded on an ongoing basis. The risk and protective factors of the adolescents most at risk will be compared with a control group of adolescents. The same factors will be reassessed in the most at-risk adolescents after 6 and 18 months of treatment as usual. The data will be collected in a data entry and storage system that will ensure the privacy of the data entered in accordance with the GDPR. This will allow the investigators to identify young people at particular risk of severe self-harm behaviour more reliably, to target them for more intensive and effective treatment, and thus to improve their safety, quality of life and prognosis in the short and long term.

NCT ID: NCT05747963 Recruiting - Insomnia Disorder Clinical Trials

Software-delivered CBT-I for Insomnia Disorder

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms. Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep. Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.