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NCT ID: NCT04804917 Completed - Depressive Symptoms Clinical Trials

3-year Follow-up of the Mind My Mind RCT

MindMyMindFU
Start date: March 22, 2021
Phase:
Study type: Observational

This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" [MMM]) compared to management as usual (MAU) in youth with emotional and behavioral problems. The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark. The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" [MMM]) compared to management as usual (MAU). The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199). The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups. The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.

NCT ID: NCT04799717 Completed - Psychotic Disorders Clinical Trials

Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

Start date: August 31, 2021
Phase:
Study type: Observational

The goal is to provide combination of 2 hours of weekly game based telehealth therapeutic intervention along with CBT-P for children identified with first onset psychosis or to be clinically high risk for psychosis thus widening therapeutic services offered. Target outcome measures are improvement in clinical symptoms, treatment engagement, and reduced hospitalization rates.

NCT ID: NCT04786054 Completed - Obesity Clinical Trials

Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.

NCT ID: NCT04783285 Completed - Schizophrenia Clinical Trials

Effect of Individual Cognitive Stimulation at Home in Adults With Psychotic Disorders

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to test the effect of cognitive stimulation (CS), applied individually and at home, on the overall cognitive functioning, emotional state, functionality, and quality of life (QoL) in adults with psychotic disorders. To this end, a randomised controlled clinical trial will be conducted in which selected participants will be randomly assigned to an individual intervention group using CS or a control group. The CS program is adapted from other existing protocol, composed of 32 sessions. Each session will last 45 minutes and will be held twice weekly. There will be four evaluation points (baseline, intra-evaluation - after 8 weeks of intervention, post-evaluation - after 16 weeks of intervention, follow-up - after 8 weeks of the end of intervention).

NCT ID: NCT04779632 Completed - Clinical trials for Autism Spectrum Disorder

Fish Oil Affects Cognition and ADHD Symptoms in Adults With Autism Spectrum Disorder

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The prevalence of autism spectrum disorder (ASD) is rising and was estimated to have a prevalence of around 1.5% in developed countries in 2016. ASD is characterized by impairments in social interaction and repetitive behavior and is associated with executive dysfunction such as impaired working memory, inhibition, and flexibility. Furthermore, ASD is often associated with multiple comorbidities such as attention-deficit/hyperactivity disorder (ADHD), depression, and anxiety. Systematic reviews and meta-analyses indicate that fish oil (FO) supplementation improves attention, impulsivity, and hyperactivity in children with ADHD and beneficial effects in adults with depression and anxiety. Some randomized trials in children with ASD have shown improvements on selected executive functions, but results from meta-analysis are inconsistent and no trial has examined the effect in adults with ASD. Furthermore, most of the previous studies have mainly assessed effects by questionnaires and no objective tests, only provided low doses (<1.5 g/d of n-3 long-chain polyunsaturated fatty acids) and none of them have examined the potential influence of comorbid ADHD, depression, or anxiety. The aim of the study was to examine the effect of FO on sustained attention and visuospatial short-term memory memory, as well as cognitive inhibition, executive function, and core symptoms of ASD, and of ADHD, and social function in adults with ASD. In light of the shared and additive cognitive impairments in individuals with both ASD and ADHD, the hypothesis was that individuals with comorbid ADHD will show the most pronounced effects. The study furthermore aimed to examine potential interaction with depression, anxiety, and gender. This was investigated in a randomized double-blind head-to-tail crossover trial in 26 adults with ASD, who are provided with FO and safflower oil (SO) for 4 weeks each. The subjects were examined at baseline and after each period with tests of attention and working memory (primary endpoints) as well as a test of cognitive flexibility and clinical questionnaires.

NCT ID: NCT04778423 Completed - Eating Disorders Clinical Trials

Feasibility and Acceptability of AVATAR Therapy in Eating Disorders.

Start date: August 5, 2021
Phase: N/A
Study type: Interventional

This project will answer the overarching research question "What is the feasibility of developing and implementing AVATAR therapy to reduce the power of the eating disorder voice in patients with eating disorders?". AVATAR therapy for eating disorders has been developed based on AVATAR therapy for psychosis. The feasibility of using AVATAR therapy in eating disorders will be tested using non-concurrent multiple baselines single case experimental design. The first stage (A1) will involve participants being randomly allocated to either a two, three or four week-baseline. The second will be the intervention phase (B) where participants will receive the AVATAR treatment which will last approximately 6 weeks. The third stage (A2) will be a 4-week follow-up period after the intervention phase, where participants will also complete a qualitative interview.

NCT ID: NCT04777292 Completed - Clinical trials for Obsessive-Compulsive Disorder

ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder

ESTOCMA
Start date: December 21, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion (an estimation of 10 days). Moreover, the stability of the changes will be tested at 3 months. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use or delayed use. We hypothesized that after using the app, participants will have a greater knowledge about obsessive-compulsive disorder, will be more prone to ask for help in case of showing OCD symptoms, and will show lower stigma attitudes and social distance.

NCT ID: NCT04774263 Completed - Disease Clinical Trials

The Acceptability of a Real-time Localization for Patients and Caregivers

RTLS
Start date: February 1, 2021
Phase:
Study type: Observational

Technological innovations are taking over our daily lives, particularly in the health sector. Real-time location systems for healthcare professionals and patients are developing in hospitals. Today few studies have focused on the acceptability of this new technology. The present research, which aims to study the acceptability of a real-time localization systems, reveals a definite utility and acceptability from the patient's point of view, subject to conditions. Indeed, the guarantee of data security and the concrete interest for the patient must be explained. For healthcare professionals working in emergency departments, the usefulness of new technologies in their work is now well established. Nevertheless, the acceptability of a real-time location systems received lukewarm reviews. It depends mainly on reticence linked to the fear of a possible deviation in the use of the data collected.

NCT ID: NCT04768959 Completed - Wellbeing Clinical Trials

Cultivating Well-being in Severe Psychiatric Conditions

FelizMente2
Start date: October 25, 2017
Phase: N/A
Study type: Interventional

The multicomponet psychological intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).

NCT ID: NCT04768218 Completed - Gastric Cancer Clinical Trials

BLI for the Diagnosis of Precancerous Conditions

Start date: March 1, 2021
Phase:
Study type: Observational

Introduction: Traditionally, White Light Endoscopy (WLE), enhanced by biopsies following the updated Sydney system guidelines, has been the benchmark for diagnosing and classifying gastric preneoplastic conditions. Nevertheless, the pronounced interobserver variability and the often weak correlation between endoscopic observations and histopathological results have driven the increasing adoption of virtual chromoendoscopy (VCE). VCE technologies have demonstrated greater effectiveness in identifying these conditions compared to WLE, with Narrow Band Imaging (NBI) being particularly notable. Significantly, NBI has played a key role in validating the Endoscopic Grading of Gastric Intestinal Metaplasia (EGGIM) system. However, data on the effectiveness of other VCE technologies in this domain is relatively sparse in Europe, specifically with Blue Light Imaging (BLI), despite the promising diagnostic performance demonstrated with this technology. Primary aim: to assess the diagnostic accuracy of BLI and to externally validate the applicability of EGGIM classification for staging GIM. Material and methods: a multicentric cohort study will be performed involving centres from two European countries (Portugal, Italy). Consecutive patients performing upper gastrointestinal endoscopy will be evaluated by WLE and BLI. Random biopsies or targeted plus random biopsies will be performed in order to determine de accuracy of BLI system to detect and stage GIM. Expected results: We anticipate that BLI would enable us to assess the extension of GIM without the need for biopsies. If observed, this would overall improve the upper GI endoscopy accuracy.