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NCT05712057
The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.
NCT06331936
The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session.
NCT07136064
Guided by the process model of emotion regulation, integrative affect-regulation framework for resilience, and the reciprocal dynamics of emotion, affect, and resilience in the family system, researchers will develop a parallel intervention to incorporate two key members in Mainland-Hong Kong cross-boundary families: a parent and a child by improving their affect/emotion regulation skills, de-escalate family conflicts, and flourish under hardships. Specifically, researchers predict that participants in the intervention group will report greater improvement in resilience, emotion regulation, psychological well-being, family harmony, and social connectedness than those in the control group.
NCT07069361
This randomized controlled trial investigates the effects of an 8-week mindfulness-based interventions, Mindfulness for Life (MBCT-L) on daily emotion regulation, psychological functioning, and work-related outcomes. The primary objective of this study is to investigate the underlying mechanism of change between mindfulness and job performance and satisfaction.
NCT07304830
This study aims to investigate the effects of the PsyPills mobile application on improving emotion regulation and reducing risk behaviors among emerging adults. PsyPills is a self-guided psychological intervention based on Rational-Emotive and Behavioral Therapy (REBT) principles and the Just-in-Time Adaptive Intervention (JITAI) framework. The app provides short, contextually adaptive "psychological pills," or cognitive restructuring exercises, designed to help users replace irrational beliefs with rational alternatives in moments of emotional distress. The study will compare PsyPills app with an active control condition using the MoodWheel app, which supports emotional monitoring without therapeutic content.
NCT05447312
The proposed study is a pilot study that aims to understand if the Pi Electronics adaptive music intervention (AM) is effective to promote positive psychosocial and cognitive outcomes, over and above a traditional music intervention (TM) among healthy older adults. This study will contribute to the ongoing literature on the benefits of music interventions and provide insight on how emerging technology can enhance the therapeutic effects of music as a viable intervention for older adults. The study will adopt a three-arm randomized controlled trial (RCT). Eligible participants will be randomized into one of three groups: traditional music therapy group (TM), Pi Electronic's adaptive music program (AM), and a waitlist control group (CG). Informed consent will be collected from all participants. All three groups will complete outcome measures at three sessions: pretest, posttest, and at a three-month follow-up, but only the TM and AM group will receive music between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting 30 minutes. Data will be analyzed for each outcome variables to understand the group differences in the performance on the psychosocial and cognitive outcome measures. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system.
NCT07096141
University students' psychological well-being is a growing public health concern. University life involves major psychological, social, and academic changes, increasing vulnerability to mental health issues. Group-based Dialectical Behaviour Therapy (DBT) has been shown to support student well-being effectively. However, interventions tailored to specific cultural and contextual needs are more likely to be helpful. Western-based therapy models may not fully align with non-Western populations, such as students in Türkiye. In Türkiye, public mental health services are often limited to short psychiatric consultations, while therapy is typically accessed privately. University counselling centres offering free or low-cost therapy are therefore essential. Cost-effective interventions like group DBT may be especially valuable in these settings. To address this gap, culturally adapted DBT groups should be developed and evaluated for Turkish university students. This study is part of the UniWELL Project (sister to UniWELL-C) and examines the effectiveness of DBT-informed emotion regulation groups for Turkish students. Any Bogazici University student aged 18+ is eligible. Exclusion criteria include severe mental illness, high risk of harm to self/others, or scoring below threshold on the Difficulties in Emotion Regulation Scale (DERS-16), as these students may require more individual support. The study includes participation in an 8-session DBT-informed group. Participants are expected to benefit from free psychological support, guided reflection, and shared experiences with peers. The research will also contribute to the evidence base for culturally adapted interventions. There are some risks: participants may feel overwhelmed during the sessions or while completing questionnaires. If so, support will be provided by a clinical psychology master's student and/or the group facilitator, under supervision of an experienced clinical psychologist. If a participant's risk increases, they will be referred to psychiatric services. An emergency contact will be requested to ensure safety if needed. The study will take place at Bogazici University through the Translational Clinical Psychology Lab, in collaboration with BUREM. It is expected to run for at least one year, possibly extending up to three years. The study is partially funded by the Bogazici Scientific Research Projects Unit (20022). Dr Ayse Akan (t-clinpsylab@bogazici.edu.tr) is the study lead and main contact.
NCT04793776
PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.
NCT07096271
This study is testing a program called Get Better Together, a relationship education program designed to help military couples effectively navigate life stressors as a team. The goal is to find out if attending Get Better Together improves mental health and relationship skills, and reduces problems like alcohol misuse, aggression, and suicide risk. Couples who join the study will be randomly placed into one of two groups. One group will attend Get Better Together at a weekend retreat. The other group will continue their usual activities and later receive access to an online relationship education program. All participants will complete surveys before the retreat and again 2, 4, and 6 months later.
NCT07193732
This study aims to develop and to evaluate the efficacy of an Islamically integrated chair-work intervention designed to assist Muslims experiencing prolonged grief in resolving unfinished business tension. Employing a randomized, non-concurrent, multiple baseline design, the study comprises five phases: (1) baseline assessment, (2) empathic attunement, (3) Traditional Islamically Integrated Psychotherapy (TIIP) chair-work intervention, (4) cognitive consolidation \& spiritually behavioral activation, and (5) follow-up. By integrating insights from early Islamic scholars like Al-Kindi, Abu Bekir er-Razi, and Ibn Sina, alongside psychological counseling and cultural elements, this intervention aims to fill a crucial gap in existing literature. Grief, a normal emotional reaction after the loss of a loved one, is typically resolved over time without professional intervention. However, a small yet significant number of individuals experience prolonged grief disorder (PGD), a persistent and impairing form of grief lasting over 6 months. Unfinished business, indicating unresolved relational issues with the deceased, is a key risk factor for severe PGD. Higher levels of unfinished business are associated with increased psychological problems and unhealthy expressions of grief. Within the framework of Traditional Islamically Integrated Psychotherapy (TIIP), unfinished business is viewed as an emotionally charged problem. Processing this emotional burden during TIIP sessions aims to facilitate resolution, replacing maladaptive emotions with adaptive ones, fulfilling emotional needs, and establishing new meanings for unresolved conflicts. Sense-making of one's loss is crucial for a healthier grieving process, making meaning-oriented techniques more effective in grief therapy. Moreover, research indicates that the expression of grief is influenced by spirituality, religious beliefs, and practices. Yet, there is a lack of faith-based intervention programs tailored for grieving Muslims. This study seeks to address this gap by providing closure and therapeutic methods that cater to the nuanced emotional struggles of bereaved Muslims, offering a faith-based approach previously unavailable in the literature.
NCT06440109
Therapeutic touch (TD) is a non-pharmacological/integrated treatment method used to balance the body by regulating the imbalanced energy field in the individual or resolving blockages in energy flow. Emotional freedom technique (EFT) is a psychophysiological intervention that combines elements of somatic stimulation using acupuncture points. This research will be conducted as a randomized controlled experimental study to determine the effect of TD and EFT intervention on postpartum mood and fatigue in postpartum women. This study is planned to be conducted between April 2024 and June 2025 with postpartum women who meet the inclusion criteria and who apply to the Obstetrics and Gynecology Clinic of Necmettin Erbakan University Faculty of Medicine Hospital. This research; It was planned to be carried out with three groups: TD intervention, EFT intervention and control group. The population of the research consists of women who gave birth vaginally and those who gave birth vaginally in the relevant hospital.
NCT05445141
Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) \[in Swedish: Alla Barn i Centrum (ABC)\] which has been evaluated for parents with children aged 3-12 years. The results showed effects on parenting ability, parenting strategies and on children's well-being. Staff in child health care (CHC), a natural arena for parental support programs reaching almost all families, have requested modifications in the program ACF to involve parents with younger children. The parent groups offered within CHC today are not evaluated in younger children and could be thus replaced by researched parental support based on evidence. The investigators therefore want to study the effects of a modified version of ACF for parents of children 1-2 years (Little ACF) to see if Little ACF can strengthen parenting ability and have effects on children's social and emotional development. Parents within CHC are asked to participate and are randomly assigned to Little ACF or the regular CHC program plus a lecture. Little ACF is offered during four group meetings and potential effects are measured with questionnaires. Measurements are made before randomisation, during and after participation in Little ACF. Children's behavior is followed up at 3 years through questionnaires and CHC documentation. The study can provide important knowledge about how Little ACF can promote children's mental health and strengthen parents. The investigators see it as a strength that Little ACF is based on research and on dialogue with parents and professionals. Little ACF, which is aimed at everyone, can form a basis for identifying families and children who need preventive and treatment measures.
NCT06239545
New challenges, stressors, and a loss of support often accompany the transition from adolescence to adulthood. Not surprisingly, transitional-aged youth (TAY) between the ages of 18-25 experience some of the highest rates of mental distress. However, access to mental health services diminish for TAY due to gaps in care when transitioning from pediatric to adult services. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth already access mental health services less frequently and face longer wait times than those in more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. Novel, innovative approaches are urgently needed to support TAY in Northwestern Ontario. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while TAY are waiting for mental health services.
NCT06154369
Students within post-secondary education settings are experiencing increasing stress, distress, and mental health difficulties. Many post-secondary education settings have identified student mental health and wellbeing as a priority and yet are struggling to adequately meet the needs of students. This has led to exploring whether technology can be used to help promote mental health and wellbeing among students. The JoyPop app is one mobile mental health app with a growing evidence base. It was developed to support improved emotion regulation - a key challenge among students struggling with distress and mental health difficulties. Using a randomized controlled trial (RCT) design, the primary objective of this research is to determine the effectiveness of the JoyPop app in improving emotion regulation among post-secondary students when compared to no intervention. The secondary objectives are to: (1) Assess change in mental health, wellbeing, and resilience between students in each condition to better understand the app's broader impact; (2) Conduct an economic analysis to determine whether receiving the app reduces other health service use and associated costs; (4) Assess students' perspective on the quality of the JoyPop app.
NCT05991154
Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in other more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for more serious outcomes. Transitional aged youth (i.e., those in their mid-late teens to early twenties) are a particularly vulnerable group. Novel, innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario. In partnership with Dilico Anishinabek Family Care, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for Indigenous transitional-aged youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while Indigenous transitional-aged youth are waiting for mental health services.
NCT06049407
emoWELL is a serious game, that is, a video game designed to inform and train in skills and competencies in a more dynamic way. emoWELL focuses on understanding and developing healthy emotional regulation strategies to improve well-being.
NCT06936397
This study aims to determine whether Cognitive Remediation Therapy (CRT) can improve attention, memory, and emotional regulation in people with schizophrenia. CRT is a structured program that includes exercises to strengthen cognitive skills such as problem-solving, working memory, and emotion regulation. The study will recruit 60 participants: 30 individuals with schizophrenia and 30 healthy individuals of similar age and gender. Those with schizophrenia will be randomly assigned to either receive CRT or be placed on a waitlist without therapy. All participants will undergo non-invasive brain activity (EEG) and emotional response (GSR) recordings before and after the therapy. The study's main question is: Does participating in a 12-week CRT program improve brain-based markers of attention and emotional regulation in people with schizophrenia? Additional tests, such as memory and emotion recognition tasks and self-report questionnaires, will help assess changes in thinking skills and emotional well-being. The study may help better understand how CRT affects both brain function and quality of life in schizophrenia.
NCT05898516
Indigenous youth in Northwestern Ontario who need mental health supports experience longer waits than non-Indigenous youth within the region and when compared to youth in other more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase risk for more serious outcomes. Novel, innovative approaches are urgently needed to provide support for Indigenous youth in Northwestern Ontario. In partnership with Dilico Anishinabek Family Care, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for Indigenous youth who are waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a key difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while Indigenous youth are waiting for mental health services.
NCT06502444
The study will test whether an online physical activity program that includes mindfulness can increase activity in women who have been abused by a relationship partner. The study also aims to test whether this intervention can improve their ability to control their emotions and use mindfulness and reduce their stress and Post-Traumatic Stress Disorder (PTSD) symptoms. The intervention is on the internet and provides participants with informational videos, as well as support and encouragement from other program participants. The intervention aims to encourage participants to choose their own physical activities and also includes components designed to foster healthy regulation of emotion (addressing negative thoughts and feelings that may get in the way of exercise, recognizing accomplishments and rewarding oneself, etc.) This activity intervention is designed to take eight weeks. Participants are tested initially (at baseline), halfway through the program (Week 4) and at the end of the program (Week 8).
NCT05726721
The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are: * Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)? * Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up? * What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions? * Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.