Clinical Research Directory

Native Spirit: Significant Aim 3: Intervention

The proposed research will used community-based participatory research methods in an urban-based American Indian (AI) community to adapt, implement, and evaluate an after-school program, called Native Spirit (NS), that seeks to improve cultural identity, self-esteem, resilience, and prevent substance use by increasing cultural engagement. Prior research suggests that AI youth that are culturally engaged experience better health outcomes. Additionally, the use of culturally-specific after-school programs has been shown to increase feasibility and sustainability of prevention programs. In order to achieve the goals of this proposed study, the Principal Investigator (PI) will work with local community members and existing tribal partners to implement the 10-session culturally-grounded after-school program and evaluate the program with the following aims: Specific Aim 3 (R00): Examine the effectiveness of NS (increases exposure to local cultural values and activities), a program that seeks to prevent or decrease substance use by strengthening self-esteem, resilience, and cultural identity with 2 Indigenous communities in Arizona using a wait-list control design with 3 data collection timepoints and participant interviews.

Immersive Training on Metacognitive Capacities of Young People

Metacognitive abilities and self-knowledge are necessary for psychological maturation and good mental functioning of individuals. It is generally agreed that an adequate representation of oneself and others is essential to establish functional interpersonal relationships. These metacognitive abilities are not adequately developed in patients with various mental health problems, such as personality disorders, eating disorders, psychosis, and depression, and are associated with the severity of the pathology. Self-awareness is a central element that begins to consolidate during adolescence. For that reason, the investigators aim to evaluate the effects of immersive training on the metacognitive abilities and self-knowledge of young people. Based on the repertory grid technique (RGT), our research team has developed a brief immersive training to enhance metacognitive abilities. This intervention facilitates the exploration of personal identity in a safe environment. Specifically, it is an immersion in the person's own world of meanings using Virtual Reality (VR), with the Explore Your Meanings (EYME) tool, a technological platform created to help mental health professionals to enhance the personal development and therapeutic change of their clients. Expected results include an increase in participants' self-concept clarity, metacognition, and reflective function as well as a deeper knowledge about their relationship with various aspects of self-knowledge and self-esteem.

The Efficacy of Treatments to Improve Self-esteem

The goal of this study is to examine the effectivity of two self-esteem interventions (COMET (Korrelboom) and CBT (De Neef)) in a general psychiatric population. The main questions it aims to answer are: * is there a difference between the two interventions in effectiveness on increasing self-esteem? * is there a difference between the two interventions in effect on levels of anxiety, depression and general mental health? * are found effects on levels of anxiety, depression and general mental health associated with changes in self-esteem? * is the ability to use imagination a moderator for outcomes in both conditions? Participants are randomised over both conditions. At baseline (T0), end of treatment (T1) and follow-up at 6 months (T2) several outcome measures are conducted, such as RSES, DASS and MHC-SF.

ACT-Based Psychoeducation for Youth With Social Media Addiction

While social media offers opportunities for connection and self-expression, it also brings significant challenges, particularly social media addiction, characterized by excessive and uncontrolled use. Although not officially recognized as a diagnostic category, its inclusion among behavioral addictions reflects its growing impact on mental health. Social media addiction may lead to psychological symptoms such as family and social conflicts, stress due to unmet responsibilities, anxiety, and irritability. This problem has become especially critical among young people. A 2025 meta-analysis found the prevalence of social media addiction among university students to be 18.4% and reported negative effects on academic achievement. Research also shows that social media addiction is associated with decreased self-esteem, emotion regulation difficulties, and dysfunctional interpersonal relationships. Social comparison tendencies and idealized digital identity presentations further harm young individuals' self-perceptions, contributing to low self-esteem and social anxiety. Interpersonal difficulties experienced in relationships are defined as "interpersonal problems," while the cognitive-behavioral processes used to resolve these difficulties are called "interpersonal problem solving." These skills are essential for effective conflict resolution, social adaptation, relationship quality, and overall well-being. Social media shapes both the emergence and resolution of interpersonal problems; however, current knowledge in this area is limited. Excessive use contributes to interpersonal conflicts, deterioration of relationships, and reduced face-to-face communication. Thus, social media addiction may impair interpersonal problem-solving skills by disrupting daily functioning. Although the literature includes correlational studies on social media addiction, self-esteem, and interpersonal functioning, research testing Acceptance and Commitment Therapy (ACT)-based psychoeducation remains scarce. This study offers a theoretical contribution by applying a third-wave therapy approach to the psychosocial challenges of the digital age. It aims to evaluate the effects of an ACT-based psychoeducation program developed for young individuals with social media addiction on self-esteem and interpersonal problem-solving skills. Given the limited number of such programs in Türkiye, this study is original and aims to fill an important gap in the literature.

The Effects of Mandala Coloring on Women During Menopause

The aim of this clinical study is to determine the effect of mandala coloring on menopausal symptoms, sexual quality of life, and self-esteem in women during menopause period. The main questions the study aims to answer are as follows: 1. Does mandala coloring reduce the severity of menopausal symptoms in women? 2. Is there an increase in self-esteem levels among women who participate in mandala coloring after the intervention? 3. Is there an increase in the quality of sexual life among women who participate in mandala coloring after the intervention? Researchers will compare the intervention group (those who participated in mandala coloring) with the control group (those who did not participate in any intervention) to evaluate the effectiveness of mandala coloring. Participants * Participants in the intervention group will attend 30-minute mandala coloring sessions once a week for 4 weeks. * Participants in the control group will not receive any intervention during the same period. * Both groups will be assessed using a questionnaire at the beginning of the study and at the end of the 4th week (pre-test/post-test).

Psychosocial Teleassistance Programme for Adults With Spina Bifida

This clinical trial assesses the effect of a telecare psychosocial intervention designed for adults with spina bifida. The intervention consists of 10 weekly 1.5-hour group sessions, followed by two 3-month follow-up sessions. Each group will consist of 6 to 7 individuals. The intervention is aimed at strengthening aspects of self-concept, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.

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.

Psycho-Social Effects of Gardening Activities in the Elderly

In this study titled "Psycho-Social Effects of Gardening Activities in the Elderly: A Study on Self-Esteem and Life Satisfaction", the elderly will be divided into two groups as experimental and control groups. Participants will be randomly assigned to the groups. No intervention will be made to the patients in the control group. Gardening activities will be performed on the patients in the experimental group as of April. The following questions will be answered in this study; Do gardening activities affect the self-esteem level of the elderly? Do gardening activities affect the life satisfaction level of the elderly?

Impact of Plastic and Aesthetic Surgery on Self-esteem

The primary objective of QUALIPLAST is to evaluate the impact of plastic and aesthetic surgery interventions on patients' self-esteem. While the demand for these procedures is steadily increasing worldwide, patients' motivations often extend beyond purely aesthetic concerns, encompassing significant psychological and emotional expectations. However, despite the growing popularity of these interventions, scientific literature remains limited when it comes to the systematic and long-term evaluation of their effects on patients' self-esteem and overall well-being. The majority of existing studies focus on short-term outcomes or functional and physical aspects, often overlooking the psychological and emotional dimensions that play a crucial role in post-operative satisfaction. Furthermore, much research is limited to specific procedures, without adopting a comprehensive approach to plastic and aesthetic surgery. This lack of robust and generalisable data hinders a full understanding of how these interventions influence self-esteem across different types of surgeries and patient profiles. QUALIPLAST stands out due to its multicentric, prospective, and large-scale nature, involving a wide range of procedures and collecting longitudinal data before the intervention, as well as at 3 and 12 months post-operatively. It will allow for the observation of self-esteem changes over time, providing a more complete and nuanced understanding of the effects of surgery. This project relies on standardized and validated measurement tools, such as the Rosenberg Self-Esteem Scale, to ensure the reliability and comparability of the results. By addressing the current gaps in the literature, QUALIPLAST aims not only to enrich scientific knowledge in this field but also to provide valuable insights for healthcare professionals to improve patient care and tailor clinical practices based on the identified psychological needs.

Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention

The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms. The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition. At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction. Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.

Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight

The goal of this clinical trial is to assess if Metacognitive Interpersonal Therapy for Eating Disorders (MIT-ED) is effective for treating various forms of Eating Disorders (ED) and reducing dropout rates. The trial will also evaluate its feasibility and outcomes in a patient group including also underweight participants. The main questions it aims to answer are: * Does MIT-ED improve eating disorder symptoms and reduce overall maintenance factors, as alexithymia, emotional dysregulation, maladaptive perfectionism, and self-esteem? * Is MIT-ED effective in reducing the severity of personality disorders and associated global psychiatric symptoms? * What are the dropout rates and adherence levels for patients receiving MIT-ED? Participants will: * Undergo an initial screening to confirm eligibility, including a comprehensive clinical interview and assessments based on inclusion and exclusion criteria for the study. * Receive up to 40 individual sessions of MIT-ED, each lasting 50-60 minutes, over a period of approximately 10-12 months. * Attend regular assessment focusing on eating disorder symptoms (Eating Disorder Examination Questionnaire, EDE-Q 6.0, and ED Interview, EDE), emotional dysregulation (Difficulties in Emotion Regulation Scale, DERS), alexithymia (Toronto Alexithymia Scale-20, TAS-20), and self-esteem (Rosenberg Self-Esteem Scale, RSES). Assessment will be conducted at baseline (before starting MIT-ED sessions), after 20 MIT-ED sessions (approximately after 5 months), post-treatment (approximately after 10 months), and at 3 months follow-up. A longer 12-months follow-up is planned. Researchers will evaluate the effectiveness of MIT-ED based on treatment adherence, symptom improvement, and the reduction of maintenance mechanisms associated with Eating Disorders. Positive results could support the design of a larger, controlled Randomized Clinical Trial (RCT).

Effectiveness of the Universal Prevention Program Super Skills for Life in Schools

This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.

First Evaluation of COMET-Y

The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem? Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training.

Resilience and Obesity Prevention in Adolescents

A cross-sectional observation study to see the associations between factors contributing to obesity , resilience, and HRQoL in Indian adolescents. Study objectives : 1. To classify consenting adolescents into normal, underweight, overweight, and obese groups. 2. To assess diet and physical activity self-efficacy, self-esteem, general resilience, optimism, and HRQoL in the above groups. 3. To compare the differences in the groups between factors contributing to obesity (dietary behavior and physical activity), resilience (diet and physical activity self-efficacy, self-esteem, general resilience, and optimism), and HRQoL in Indian adolescents Main research question: Is there a relationship between resilience (measured as diet and physical activity self-efficacy, self-esteem, general resilience, and optimism) and BMI Z score in 14 - 16 years old school children from Kolkata? To answer this, the following sub-questions will be studied: 1. Is there a difference in resilience between the different groups of children (underweight, normal, overweight and obese)? To investigate this question, the level of diet and physical exercise self-efficacy, self-esteem, general resilience, and optimism will be investigated among overweight, obese, underweight, and normal-weight adolescents while controlling for age, gender, and type of school. 2. Is there a relationship between HRQoL and BMI Z score in different groups of children (underweight, normal, overweight and obese)? To investigate this question, the level of HRQoL will be investigated among overweight, obese, underweight, and normal-weight adolescents while controlling for age, gender, and type of school. 3. Is there a relationship between resilience and dietary behavior and physical activity in different groups of children (underweight, normal, overweight and obese) controlling for age, gender, socio-economic status and type of school? 4. Is there a relationship between parents' nutrition knowledge and resilience in children? To investigate this question, the level of parents' nutrition knowledge will be investigated among underweight, normal, overweight and obese adolescents while controlling for age, gender, and type of school.

Global Controlled Trial on Effects of an Online Self-Help Program for of Ambitious Altruists on Their Mental Health, Wellbeing, and Productivity: Comparing Versions With IFS vs. CBT, Buddy- vs. Group-, Standard- vs. Minimum-Guidance Intensity.

This study aims to compare different versions of a 16-week online self-help program in terms of their effect on self-assessed mental health, well-being, and productivity. The versions differ in their intensity (standard, low) and type (buddy, group) of guidance, the applied psychotherapeutic approaches taught (IFS, CBT). We expect to recruit a sample of \~150 ambitious altruists and have them self-select into the four program versions. Participants take part in surveys before, at weeks 8, 12, and 16 to self-assess their productivity, mental health burden, quality of life, and other risk and protection factors. Weekly screenings will provide data on objective and subjective success components such as participant engagement, working alliance, and treatment adherence, which will be correlated with primary and secondary outcomes.

The Relationship Between Body Perception and Self-Esteem Level and Quality of Life in Adolescent Idiopathic Scoliosis

Scoliosis is a three-dimensional, multifactorial disease that becomes more prevalent in adolescents, disrupts the three-dimensional mechanism and posture of the vertebra, causes deterioration in the person's body perception and cosmetic perception, and also causes negative effects on social life and quality of life. Although idiopathic scoliosis is more common during adolescence, its cause is not yet known. It is divided into three subheadings according to the age of onset. These are respectively; It is classified as Juvenile Idiopathic Scoliosis (0-3 years), Infantile Idiopathic Scoliosis (4-10 years), Adolescent Idiopathic Scoliosis (10 years and above). The most common one is Adolescent Idiopathic Scoliosis. Its incidence in girls is 4 times higher than in boys. This study aimed to examine the effects of body image and self-esteem on quality of life in idiopathic adolescent scoliosis patients and to determine whether there is a difference between genders. Additionally, it will be examined what effect the duration of corset use has on these parameters.

Online Brief CBT Intervention for Women With PCOS

Primary Objective: -To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline. Secondary Objective(s): 1. To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 2. To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 3. To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline. 4. If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.

Impact of Nipple Micropigmentation in Mastectomized Women

This will be a multicenter prospective descriptive case series study following a cohort. The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service. CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women.

Effects of a Relaxation and Guided Imagery Intervention in School Context

Specific aims - To test the effects of a relaxation and guided imagery intervention with socioemotional learning content on a range of socioemotional, physiological, cognitive and academic outcomes of school-aged children, measured through self-reports, neuropsychological and physiological measures, as well as teachers and parent's reports.