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Psychosocial Problem clinical trials

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NCT ID: NCT06138301 Recruiting - Social Isolation Clinical Trials

Telepsychiatry for Social Isolation in Youths

SOLITAIRE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants. The main questions that this project aims to answer are: - What is the general feasibility and applicability of the proposed digital interventions? - What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI? Participants will be asked to undergo: - A detailed clinical and neuropsychological evaluation (pre-post treatment) - A blood sample (pre-post treatment) - A telepsychiatry intervention (cognitive behavioural therapy (CBT) and/or cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members) The researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects. The same PE intervention will be offered to the family members of all recruited SI participants.

NCT ID: NCT05806658 Recruiting - Stroke Clinical Trials

A Theory-driven Visual Arts-based Intervention for Community-dwelling Stroke Survivors

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Stroke leads to psychosocial issues for community-dwelling stroke survivors in their recovery journey. Previous studies showed the benefits of visual arts-based interventions in enhancing self-efficacy and psychosocial functions. However, the interventions were not well designed with a theoretical framework. This study will evaluate the effectiveness of a theory-driven visual arts-based intervention on community-dwelling stroke survivors' psychosocial outcomes. A two-arm randomised controlled trial will be conducted to test the effects of this intervention and assess its feasibility in the community.

NCT ID: NCT05769374 Recruiting - Clinical trials for Overweight and Obesity

Effects of Parental Involvement in Exergames Play on Physical and Mental Health on Overweight and Obese Male Adolescent

Start date: July 22, 2022
Phase: N/A
Study type: Interventional

In recent years, with the rising obesity rate, overweight and obesity have become a hot issue of public health. As a sensitive and special group, teenagers shoulder the heavy responsibility of building the motherland, so their health is also the focus of scholars and experts. As a new type of sports game, active video game(AVG) has been proved by many studies to be able to effectively improve the sedentary behavior of teenagers, and can completely become a substitute for today's popular smart phones. In addition, due to the increase of overweight and obese teenagers, a series of psychological problems, such as anxiety, depression, and low self-esteem, also troubled this group. Some researchers can effectively improve the psychological status of the subjects through the intervention experiment of AVG. However, there are few studies on psychosocial beliefs at present, and the impact of psychosocial variables such as self-efficacy, social support and quality of life on overweight and obese groups is extremely important. Moreover, due to the impact of the COVID-19 epidemic, the relationship between family members will also change, especially the alienation and rigidity of the relationship between children and parents will show a significant growth trend. Therefore, this study mainly takes AVG play with parents' participation as the main intervention means to influence the physical activities, psychosocial beliefs and quality of parent-child relationship of the experimental target.

NCT ID: NCT05711342 Recruiting - Aggression Clinical Trials

The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Even though internet-based interventions have been used in treatment of forensic psychiatric outpatients for over ten years, no robust research into their effectiveness has taken place. Multiple potential benefits and barriers have been observed in clinical practice, such as the possibility to increase a patient's treatment readiness, self-efficacy and thus reduce undesired behaviour such as reactive aggression. However, therapists indicate that these interventions do not seem to work for all forensic psychiatric patients, and that uptake is generally quite low. There is an urgent need to evaluate if and how these internet-based interventions are of added value for treatment of forensic psychiatric outpatients. The main goal of this study is to investigate whether the addition of the existing internet-based intervention 'Aggression' to treatment as usual of forensic psychiatric outpatients leads to better treatment outcomes than treatment as usual that is delivered solely in-person. This study uses a multicentre mixed methods randomized controlled trial (RCT) design, with four participating Dutch forensic psychiatric outpatient care organizations. Patients are included if they receive outpatient treatment for aggression regulation problems and will be randomized into an experimental condition, in which the internet-based intervention is added to treatment as usual (TAU), or a control condition, with only TAU. Participants are assessed four times: at baseline (T0), halfway during the 10-week intervention (T1), after completing the intervention (T2), and after three months (T3). Primary outcome measures are regulatory emotional self-efficacy, treatment readiness, and aggression, assessed via validated self-report questionnaires. Secondary outcome measures are the number of in-person treatment sessions during the data collection, and dynamic risk factors. Adherence to and engagement will be studied as potential predictors for effectiveness via respectively log data and a self-report questionnaire. Perceived benefits, barriers and points of improvement will be identified via qualitative interviews with participating patients and therapists. This will be the first experimental study to investigate an internet-based intervention in a forensic psychiatric outpatient sample. By using a mixed-methods design and by adding adherence and engagement as potential predictors, this study can not only answer questions about if, but also why and for whom this intervention works. Consequently, this study will answer an important question from clinical practice: are these types of interventions - which have been used in practice for over ten years - actually of added value for treatment?

NCT ID: NCT05472480 Recruiting - Vascular Diseases Clinical Trials

Anthropometric and Psychosocial Measurements in Vascular Disease

ANPSYSOMEVAD
Start date: July 1, 2019
Phase:
Study type: Observational

This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements. Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated. Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.

NCT ID: NCT05336318 Recruiting - Cancer Clinical Trials

Peer2Me: A Peer Supported Program for Adolescent and Young Adult Cancer Patients

Peer2Me
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The present bicentric study has the aim to investigate the effectiveness of the peer supported mentoring program 'Peer2Me' with regard to psychosocial parameters using a prospective Comprehensive Cohort Design. Over a period of three months, acutely ill patients in the intervention group are accompanied by a mentor with the same disease and of similar age. Patients in the control group receive a one-time consultation. Before and after the intervention, mentors and mentees are interviewed about their psychosocial distress and quality of life.

NCT ID: NCT04680611 Recruiting - Depression Clinical Trials

Severe Asthma, MepolizumaB and Affect: SAMBA Study

SAMBA
Start date: September 9, 2021
Phase:
Study type: Observational

This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).

NCT ID: NCT04244864 Recruiting - Depression Clinical Trials

Cross-sectoral Collaboration in Multidisciplinary Treatment of Trauma-affected Refugees

Start date: February 3, 2020
Phase: N/A
Study type: Interventional

INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic stress, refugees are furthermore subject to a range of post-migration stressors e.g. unemployment, poor finances and language difficulties. These stressors can moderate or exacerbate mental health outcomes in refugees. Cross-sectoral collaboration and coordination of municipal social interventions and regional mental health services are currently limited. The overall aim of this study is to investigate the effect of a psychosocial treatment with a focus on social stressors in an integrated cross-sectoral collaboration with the municipality for trauma-affected refugees MATERIALS AND METHODS The study is being conducted at Competence Centre for Transcultural Psychiatry (CTP) in Denmark. Included in the study are refugees with post-traumatic stress disorder (PTSD), who are unemployed and attending a municipal job centre in one of the five collaborating municipalities. Approximately 200 patients will be included. The randomised controlled trial is comparing treatment as usual (TAU) comprising 10 sessions with a medical doctor (pharmacological treatment and psycho-education) and 16-21 sessions with a psychologist (manual-based cognitive behavioural therapy) with add-on of the social intervention. Overall, the intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with municipality through collaborative meetings and by a systematic focus on social stressors during the treatment. The primary outcome is functioning, measured by WHODAS 2.0 12 item version together with a variety of secondary outcomes measuring mental health symptoms, quality of life and degree of social stressors. RESULTS The study is expected to bring forward new perspectives and knowledge on psychosocial treatment of trauma-affected refugees as well as cross-sectoral collaboration.

NCT ID: NCT02672670 Recruiting - Spinal Cord Injury Clinical Trials

Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation

Start date: August 2016
Phase: N/A
Study type: Interventional

The aim of this proposed PhD study is to test the effectiveness of a newly developed coping-oriented supportive programme (COSP) for Chinese people with SCI during their early period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping abilities, self-efficacy, mood status, and life satisfaction, when compared to those receiving routine care in another two rehabilitation wards. This proposed PhD study is a quasi-experimental study, using repeated-measures, comparison group design. The study will be conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in each of the two study groups (i.e., one intervention and one comparison group). The intervention group will receive the COSP including 8 weekly sessions, and the comparison group will receive usual rehabilitation care in brief didactic group-based education. Outcome measures will be examined at baseline and immediately, 1- and 3-month after completion of the interventions. The primary outcomes of this proposed study are coping ability and self-efficacy, while the secondary outcomes include mood status, life satisfaction, and pain. All data will be analysed using SPSS for Windows, version 21.0. Descriptive statistics will be employed for demographic and disease-related data and outcome scores. Data analysis for intervention effects will be based on both Per-protocol (PP) analyses and Intention-To-Treat (ITT). The missing data will be handled by the Last Observation Carried Forward (LOCF) strategy. Inferential statistics will be conducted for between-group and within-group comparison with specific considerations with the measurement level of the data and the fulfillment of the statistical assumptions of parametric or non-parametric tests, and further consider to use multivariate analysis of covariance (MANCOVA) or the analysis of covariance (ANCOVA).This study will provide evidence on the clinical effectiveness of the coping-oriented supportive programme in improving patients' psychological adjustment to SCI during earlier stage of inpatient rehabilitation, enhancing their psychosocial adaptation to the illness and subsequent life satisfaction and hence, integrating this psychosocial intervention into the conventional treatment and SCI rehabilitation practices.