Clinical Research Directory

Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples

Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms. This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control. Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health. Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.

PACE Study: School-Based Mindfulness and Compassion Interventions for Children

This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions. The interventions are delivered in the classroom through structured experiential activities. Children are assessed before and after the interventions using standardized tests and questionnaires measuring attention, executive functions, emotional regulation, mindfulness, self-compassion, and social-emotional skills.

DOD Regulating Together Intervention

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

Evaluating Additive Effects of Including Canines in Regulating Together

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

Neurostimulation Versus Therapy for Problems With Emotions

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.

GUTLINK4KIDS Intervention

This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.

Assessment of Emotion Regulation Strategies Used When Suicidal

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include: 1. Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1. 2. Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1. 3. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation. 4. Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies. 5. (Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up.

Jockey Club Support Project

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.

Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

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.

Improving Emotional Wellbeing of University Students: Emotion Regulation

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.

Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children

The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs). The main questions it aims to answer are: 1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU? Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will: 1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in a \~weekly, outpatient intervention lasting around 3-4 months 3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention

The Effects of Group Social Work Intervention on Children's Emotional Intelligence, Emotion Regulation Skills and Empathy Tendencies

The general objective of this study is to determine the effects of an emotion-focused therapy-based group social work intervention on the emotion regulation skills, emotional intelligence, and empathic tendency levels of children aged 9-11 years in need of protection and living in a children's home complex, and to explore the participants' experiences of the group intervention. The independent variable of the study is the emotion-focused therapy-based group social work intervention. The dependent variables are the children's emotion regulation skills, emotional intelligence, and empathic tendency levels. Within the framework of the stated general objective, the quantitative questions addressed in the study are as follows: 1. Is there a significant difference between the emotion regulation skills, emotional intelligence, and empathic tendency scores between the experimental and control groups before the intervention? 2. Is there a significant difference between the pre-test and post-test scores of the emotion regulation skills, emotional intelligence, and empathic tendency of the participants in the experimental group after the intervention? 3. After the intervention, is there a significant difference between the pre-test and post-test scores on emotion regulation skills, emotional intelligence, and empathic tendency of the participants in the control group? 4. After the intervention, is there a significant difference between the post-test scores on emotion regulation skills, emotional intelligence, and empathic tendency of the participants in the experimental group and the post-test scores on emotion regulation skills, emotional intelligence, and empathic tendency of the participants in the control group?

Manage Emotions to Reduce Aggression (MERA)

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.

Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease

Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.

Get Better Together: Relationship Education For Military Couples

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.

Islamically Integrated Chair-Work for Bereaved Muslims

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.

Enhancing Early Care and Education Through Reflective Supervision

The goal of this clinical trial is to test an enhancement to early care and education, which is a professional development series that includes a foundational training and skill development workshops focused on training and supporting early learning supervisors in Reflective Practice and Supervision. Directors and education coordinators within state pre-kindergarten programs, and the teachers they supervise, will be the focus of this research. Hypothesized outcomes include promotion of reflective capacity and supervisory skill in supervisors, more effective supervisor-supervisee interactions, increases in reflective functioning and well-being in supervisees, increases in positive teaching practices and observed classroom quality, and increases in adaptive social-emotional development among children alongside prevention of emotion regulation difficulties. Researchers will compare whether these outcomes differ between participants who are currently receiving the Reflective Supervision enhancement and participants who are in the waitlist control condition.

Little ACF (Lilla ABC): Evaluation of a Parental Support Program for Parents of Children Aged 1-2 Years

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.

JoyPop Mobile Mental Health App With Transitional-Aged Youth

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.

JoyPop Mobile Mental Health App With Youth

Youth in Canada are in need of novel, innovative approaches to support their mental health and wellbeing. Within this age group, research suggests rates of several mental health difficulties and related hospitalizations have increased over recent decades. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth access mental health services less frequently and face longer wait times than those in more urban areas. Such limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. 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 youth 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 and an ability still undergoing maturation during this developmental period. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while youth aged 12-17 are waiting for mental health services.

JoyPop Mobile Mental Health App With Indigenous Transitional-Aged Youth

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.

Feasibility of a Dog Training Therapy Program in UC Outpatient Youth Receiving Psychiatric Services

The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in Lawrence Hall, a Chicago-based residential treatment center for maltreated youth. In this study, the investigators test the feasibility, acceptability, and short-term efficacy of expanding the program to a group of youth currently in outpatient treatment for social, emotional, and behavioral problems. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.

LH Canine Therapy Study

The goal of this pilot project is to test for initial efficacy of the Recovery \& Care Canine-Assisted Therapy program that has been developed and implemented in youth institutionalized for behavioral and emotional problems. We are using two study sites, Lawrence Hall and Lydia Home, both Chicago-based residential treatment centers for youth with behavioral and emotional problems, many of whom have experienced child maltreatment and trauma. Comparisons will be made to a matched sample of youth from Lawrence Hall and Lydia Home receiving treatment as usual. Results from this project will provide preliminary evidence of whether a structured, goal-oriented intervention program focused on dog training activities has direct impact on increasing youth emotional self-regulation, impulse control, and self-efficacy, which are important targets for intervention among youth with mental health problems. If successful, this project could lead to a larger, randomized control clinical trials study that tests the longitudinal impact of the program that could further lead to national dissemination of the Recovery \& Care curriculum as an alternative therapeutic approach.