Coping encompasses the strategies and processes individuals use to manage stress, challenges, and emotional difficulties across a variety of contexts. Clinical trials related to coping often investigate behavioral and psychological interventions desi...

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Found 1100 Actively Recruiting clinical trials

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Researchers are evaluating the "One All" curriculum, which uses the sport Ultimate Frisbee to improve mental health resilience among young tribal people in two communities in South India. The study aims to see if this intervention is feasible and acceptable while assessing its effectiveness in building resilience and mental well-being. The research involves young tribal adults aged 12 to 25 years from Gudalur in Tamil Nadu and BR Hills in Karnataka. The intervention includes a three-year curriculum delivered by trained community facilitators who adapt the program to fit local needs. Participants attend two or more sessions each week, each lasting about one and a half hours. Sessions involve warm-up activities, drills, ultimate frisbee games with modified rules, and group discussions called spirit circles. The program focuses on developing skills such as self-management, social awareness, empathy, identity building, and conflict resolution. Participants undergo assessments before the program starts, after 12 months, and after 18 months. These include questionnaires measuring resilience (Child Youth Resilience Measure and Connor-Davidson Resilience Scale), mental health (GHQ12), and self-efficacy. Researchers will track attendance and reflections from sessions but will not access medical records. The study involves a baseline interview collecting socioeconomic data and assigns participants codes to protect privacy. Total participation lasts at least 18 months to evaluate outcomes.

Age: 12Years - 25YearsAll GendersPhase Not Applicable
2 locations
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Researchers are evaluating how forming a physical activity (PA) identity within families can promote long-term physical activity among children aged 6 to 12 years. The study compares an identity formation approach, which includes education and planning plus additional coaching, to a standard education and planning condition. The main goal is to see if children in the identity formation group increase their moderate- to vigorous-intensity physical activity (MVPA) more over six months. Participants are divided into two groups. One group receives sessions, informational booklets, and worksheets based on Canada's PA guidelines, focusing on how parents can support their child's physical activity through encouragement, logistical help, and doing activities together. This group also receives materials on healthy family eating. The other group receives the same materials plus two extra coaching sessions that include family PA identity activities, such as assigning fun PA roles to family members and creating family PA items like t-shirts and photos, to strengthen social identity related to physical activity. During the six-month study, researchers will monitor children's MVPA at baseline, 6 weeks, 3 months, and 6 months. Additional assessments include parent-child activity tracking through accelerometers and self-reports, body measurements, cardiovascular and musculoskeletal fitness tests, and social identity questionnaires. The study aims to understand how family support and identity impact children's physical activity and health outcomes, with the University of Victoria leading the research.

Age: 6Years - 12YearsAll GendersPhase Not Applicable
2 locations
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Researchers are investigating how the antidepressant citalopram affects the brain's response to emotional information, focusing on the amygdala, a key brain area involved in depression. This study explores how different parts of the amygdala react to positive and negative emotional stimuli, using advanced brain scanning technology to understand the underlying brain mechanisms. Participants will receive a single oral dose of either 20 mg citalopram or a placebo in a randomized, double-blind design. After dosing, participants will undergo high-strength 7T fMRI brain scans while viewing emotional faces. This precise imaging allows researchers to observe how citalopram influences specific subfields of the amygdala during emotional processing. Participants will be screened for medical and psychiatric health before joining. During the study, brain activity and behavioral responses such as accuracy and reaction time during a gender discrimination task will be measured about three hours after dosing. The study includes safety monitoring and lasts for a few hours on the study day, focusing on neural and behavioral outcomes related to emotional processing.

Age: 18Years - 40YearsAll GendersPhase Not Applicable
1 location
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Healthy Volunteer

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Age: 18Years +All GendersPhase 2
3 locations
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Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.

Age: 6Years - 10YearsAll GendersPhase Not Applicable
1 location
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Healthy Volunteer

Researchers are comparing two school-based programs, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is more effective at reducing anxiety and improving emotion regulation in autistic students aged 8 to 14 years. This study focuses on autistic youth who experience anxiety and aims to help schools better support their mental health, especially students from underserved communities. The trial will also assess how well each program is accepted by students, caregivers, and school providers. The study involves 200 autistic students with anxiety who will be randomly assigned to one of the two programs for 12 weeks. FYF-SB uses cognitive-behavioral therapy (CBT) strategies focused on anxiety reduction through psychoeducation and gradual exposure to fears. ZOR teaches students to recognize and manage emotions by categorizing feelings into four "zones" using color codes and providing strategies to regulate emotions. Trained school providers will deliver the programs to small groups of students in their schools. Participants will be evaluated before and after the intervention, with a follow-up six months later. Assessments include anxiety and emotion regulation measures completed by students, caregivers, teachers, and independent evaluators. The study will also track school attendance, disciplinary actions, academic participation, and satisfaction with the programs. Researchers will examine treatment effects and gather feedback through surveys and interviews to understand how feasible and acceptable each program is in school settings.

Age: 7Years - 15YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a digital health intervention using a mobile application called "Pust Deg Bedre" (PDB) to support self-management in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD patients often experience symptoms like dyspnea, cough, and chronic mucus hypersecretion, which increase infection risks and exacerbate the disease. This study aims to explore the feasibility, patient and physiotherapist experiences, and implementation of the PDB app in managing these symptoms. The intervention involves physiotherapists providing patients with training on how to use the PDB app, which offers tailored breathing and airway clearance techniques based on clinical assessment. Patients will engage with the app's treatment plan over an 8-week period, with follow-up at 6 months. Adjustments to the treatment plan may be made during the intervention. The study includes qualitative interviews and video-recorded physiotherapy sessions to gain deeper insights into the interactions and experiences of patients and physiotherapists. Participants will be assessed through questionnaires and interviews at the end of the 8-week treatment and at the 6-month follow-up. Researchers will collect both quantitative and qualitative data, including health-related outcomes, adherence, adverse events, and patient satisfaction. Physiotherapists will also be followed up to explore the impact of participation on their clinical practice. The total study duration includes the initial intervention and a long-term follow-up, aiming to gather comprehensive information on the app's usefulness and acceptability.

Age: 18Years - 90YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

Age: 25Years - 39YearsAll GendersPhase Not Applicable
4 locations
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Road traffic accidents cause significant health problems worldwide, leading to many injuries and deaths. This research evaluates the feasibility and acceptability of Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) to reduce post-traumatic stress symptoms, depression, and anxiety, and to improve quality of life in people who survived traffic accidents. The study uses a randomized control design involving adults aged 18 to 45 years, assessing outcomes before treatment, after treatment, and at one-month follow-up. Participants will be randomly assigned to receive either the EMDR-IGTP-OTS group therapy, which combines EMDR eight-phase protocols with the Butterfly hug technique, or to a control group with no intervention. The study evaluates how well this group therapy works and how acceptable it is for people recovering from ongoing traumatic stress due to road accidents. During the study, participants are assessed at three points using the Urdu Impact of Event Scale-Revised (UIES-R), Depression Anxiety Stress Scales (DASS-21), and the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The research team will monitor symptom changes and quality of life improvements over four weeks. The total study duration spans from enrollment through a one-month follow-up, aiming to support trauma-focused care in diverse and resource-limited settings.

Age: 18Years - 45YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants' usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

Age: 18Years +All GendersPhase Not Applicable
1 location

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