Premenstrual Dysphoric Disorder (PMDD)

Researchers are investigating whether low doses of radiation therapy can help the drug elranatamab improve its ability to kill cancer cells in patients with relapsed or refractory multiple myeloma who also have extramedullary or paramedullary disease. This phase 2 study aims to evaluate the overall response rate at 3 months and to understand safety, time to next treatment, progression-free survival, overall survival, quality of life, and local control of irradiated lesions. Participants will receive elranatamab given intravenously along with radiotherapy aimed at priming the immune system to enhance the drug's effect on cancer cells. The study focuses on treating lesions that have not been previously radiated and can be targeted with radiation. This trial is sponsored by M.D. Anderson Cancer Center and involves monitoring response differences between patients with extramedullary versus paramedullary disease and between high-risk and standard-risk groups. During the study, participants will be closely monitored for safety and adverse events for about one year. Researchers will collect data on treatment effects, quality of life, and disease progression. Assessments will include imaging to confirm disease location, blood tests to monitor blood counts and organ function, and performance status evaluations. The total duration of participation depends on individual treatment and follow-up needs throughout the study.

Researchers are evaluating whether a combination of brain stimulation and cognitive training can improve thinking skills and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). This study focuses on using repetitive Transcranial Magnetic Stimulation (rTMS) along with an immersive virtual reality cognitive training program (iVCT) to see if these therapies together help more than brain stimulation alone or no intervention. The research also looks at effects on mental health, daily functioning, quality of life, and caregiver burden. Participants will be assigned to one of three groups: a control group receiving usual care with no intervention, a group receiving rTMS treatments five days a week for two weeks (total 10 sessions), or a group receiving rTMS followed by 30 to 60 minutes of virtual reality cognitive training each day for the same two-week period. All participants will undergo initial assessments before treatment. During the study, participants will complete evaluations at the start, two weeks after treatment, and three months later to measure changes in cognitive abilities, emotional health, daily functioning, and caregiver burden. Tests include the Hopkins Verbal Learning Test and other questionnaires. The study aims to understand both immediate and lasting effects of these therapies over several months, with total participation lasting about three months.

Researchers are evaluating the effectiveness of two types of LGBTQ-affirmative psychotherapies delivered via telehealth for sexual and gender minority adults who have nonaccepting parents. The study focuses on adults living in New York, Pennsylvania, Connecticut, and Israel. It aims to see if these therapies reduce symptoms of depression and anxiety and to understand how specific factors like rejection sensitivity and parental acceptance affect mental health outcomes. Participants will be randomly assigned to receive either a 16-week course of individual LGBTQ-affirmative cognitive behavioral therapy (CBT) or 16 sessions of attachment-based family therapy (ABFT-SGM). The CBT sessions are delivered weekly and focus on addressing minority stress mechanisms, while the family therapy involves sessions with the adult child alone, with their parent(s), and with the parent(s) alone, aiming to improve the parent-child relationship regarding sexual orientation and gender identity. During the study, participants will complete assessments measuring depression, anxiety, suicidal thoughts, internalized stigma, emotion regulation, parental acceptance and rejection, and relationship quality at the start, immediately after treatment, and five months later. The researchers will monitor changes in these areas to evaluate treatment effects and mechanisms. The total duration of participation includes the 16-week therapy period plus follow-up assessments up to five months post-intervention.

Researchers are evaluating the effectiveness of a 10-session LGBTQ-affirmative cognitive behavioral psychotherapy (CBT) delivered via telehealth for sexual minority women experiencing heavy drinking and mental health issues such as depression and anxiety. This randomized controlled trial compares the EQuIP treatment, which targets minority stress responses contributing to these health disparities, to LGBTQ-affirmative treatment-as-usual. The study aims to identify whether EQuIP reduces heavy drinking and mental health symptoms more effectively and examines psychosocial factors that may influence outcomes across different demographic groups. Participants are randomly assigned to one of two groups: the experimental group receives 10 weekly individual CBT sessions focused on minority stress mechanisms related to depression, anxiety, and alcohol abuse, delivered remotely. The comparator group receives 10 weekly LGBTQ-affirmative therapy sessions via telehealth from therapists at the Institute for Human Identity. Both groups complete sessions over a similar time frame following an initial baseline assessment. During the study, participants undergo assessments at baseline and at 4, 8, and 12 months afterward. These evaluations include measures of heavy drinking, depression and anxiety symptom severity, PTSD symptoms, suicidal ideation, alcohol and drug use, and related problems. Researchers also monitor mental health symptom presence and impairment. The total participation includes these follow-up periods to track changes over time and assess the sustained impact of the treatments.

Researchers are studying the effects of advanced integrative specialty medical care on adults and children with chronic or serious illnesses and mental health disorders. This observational prospective case series aims to evaluate health-related quality of life outcomes in patients receiving care at the AIMS Institute, which combines integrative medical approaches with specialty care to serve diverse patient populations. The study is conducted by the Advanced Integrative Medical Science Institute and focuses on real-world patient experiences over time. The care provided at the AIMS Institute involves coordinated, team-based treatment from various specialists including naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology. Care providers include allopathic medical doctors, psychiatric specialists, psychotherapists, naturopathic physicians, advanced practice nurses, and health educators. The program also offers advanced treatments such as drug-assisted psychotherapy, medical cannabis education, sympathetic nerve blocks, and some intravenous therapies, with most services covered by insurance. Participants include new and established patients receiving care at the AIMS Institute. Researchers will review clinic-wide patient records and outcomes before enrollment and follow patients over a five-year period to measure health-related quality of life and treatment effects. The study involves collecting data from medical records and patient questionnaires, focusing on long-term outcomes without altering the usual care patients receive.

Premenstrual dysphoric disorder (PMDD) is a serious mood disorder affecting many women, believed to be caused by changes in sensitivity to hormone fluctuations during the menstrual cycle. This research will study the levels of certain brain-related hormones and receptor proteins in women with and without PMDD during the premenstrual phase. It will also explore how a low-dose antidepressant medication affects these measures in women with PMDD to better understand the disorder and its treatment mechanisms. The study includes three groups: women without premenstrual symptoms, women with PMDD taking sertraline 50 mg daily during the second menstrual cycle, and women with PMDD taking a placebo pill in the second cycle. Participants will track their mood, complete surveys, and have blood samples taken multiple times across one or two menstrual cycles. The sertraline or placebo is taken from ovulation until the start of menstruation in the second cycle. Participants will be involved in mood tracking, self-report questionnaires, and blood draws throughout the study. Researchers will measure neuroactive steroid levels, enzyme expression related to these steroids, and receptor subunit levels during and after the menstrual phases. The study will monitor these changes over cycles lasting up to three months, with careful safety and symptom monitoring. Participation lasts across one or two menstrual cycles depending on the group.

Researchers are evaluating the impact of a virtual psychological intervention on recovery outcomes for patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) surgery. This randomized controlled trial aims to determine whether virtual cognitive behavioral therapy (CBT) modules, delivered alongside standard care, can improve return to sport and postoperative recovery compared to standard care alone. The study focuses on patients over age 12 undergoing their first ACLR surgery with a specific orthopedic surgeon. Participants will be randomly assigned to one of two groups. One group receives standard post-operative rehabilitation only, while the other group receives the same rehabilitation plus access to asynchronous virtual CBT modules before and after surgery. These virtual sessions are designed to provide strategies to support recovery and are delivered by trained health professionals. The study is expected to last two years, with both groups following the same rehabilitation plan. Throughout the study, participants will be assessed at 3, 6, 12, and 24 months after surgery. Researchers will collect data including return to sport status, physical function and pain interference scores, depression screening results, psychological impact of returning to sport, opioid use after surgery, and use of additional counseling services. Protected health information will be securely managed, and all assessments will help evaluate the benefits of adding virtual psychological support to ACLR recovery.

Researchers are evaluating a new brief video tele-cognitive behavioral therapy called BRIGHT for survivors of head and neck cancer who experience significant body image distress. This multi-center randomized clinical trial compares BRIGHT to an attention control supportive care intervention to see if BRIGHT can reduce body image distress and improve psychological and social well-being and quality of life. The study will include 180 participants and explore how BRIGHT affects coping skills and automatic negative thoughts related to body image. Participants will be randomly assigned to one of two groups: BRIGHT or Attention Control (AC). BRIGHT involves six weekly 60-minute sessions conducted one-on-one by a licensed clinical psychologist via video telehealth. Sessions cover topics such as understanding body image, self-monitoring, cognitive restructuring, coping strategies, social support, and planning for setbacks. The AC group receives six weekly 60-minute tele-supportive care sessions addressing non-body image topics like survivorship, side effects, psychosocial aspects, nutrition, financial distress, and cancer recurrence. Both interventions control for attention and delivery method. Throughout the study, participants will complete the IMAGE-HN questionnaire to measure body image distress, along with assessments of psychological symptoms, social participation, quality of life, and coping mechanisms at 2, 3, 6, and 9 months after randomization. Researchers will also conduct interviews and site visits to understand how to best implement BRIGHT in clinical care. The total follow-up lasts 9 months, with a focus on body image and mental health outcomes among head and neck cancer survivors.

This research focuses on educators and school-aged children in Puerto Rico who have experienced high stress, burnout, and trauma due to natural disasters and the COVID-19 pandemic. The study evaluates two treatment approaches: a mindfulness-based curriculum for educators and students, and Cue-Centered Therapy (CCT) for children showing symptoms of Post Traumatic Stress Disorder (PTSD). Additionally, it aims to explore genetic factors related to resilience by studying gene expression changes before and after interventions. Participants include students, teachers, and counselors who will engage in various interventions. Students receive a mindfulness curriculum in classrooms for 6-8 weeks, while teachers and counselors are trained to deliver mindfulness and CCT treatments. Students with PTSD symptoms during the mindfulness program may undergo 15-18 weeks of CCT. Some students will provide DNA samples before and after interventions to analyze genetic markers linked to resilience. Throughout the study, participants complete surveys at baseline, post-intervention, and follow-up points to assess changes in resilience, anxiety, depression, somatic symptoms, and family functioning. Genetic methylation patterns are also measured. The study monitors the impact of these treatments on psychological well-being and socioemotional development, with research lasting up to 23 weeks for outcome assessments and ongoing genetic analysis.

Adolescent alcohol and other drug use is a major public health problem that leads to serious health, social, and economic consequences for young people. Early identification and intervention are crucial to improving outcomes. This study evaluates whether a centralized, virtually delivered version of Screening, Brief Intervention and Referral to Treatment (SBIRT) can be implemented cost-effectively in pediatric primary care to better identify and treat adolescents at high or severe risk of substance use and related mental health problems. It compares this virtual model to the traditional in-person SBIRT approach in a large, diverse health system. The trial involves two groups of pediatric primary care clinics: one where behavioral health clinicians provide brief interventions in person by appointment (Traditional SBIRT), and another where interventions are delivered virtually by video or telephone through a centralized behavioral health clinician (Centralized Virtual SBIRT). This approach aims to overcome barriers like lack of trained staff and time constraints in busy clinics. Both methods focus on adolescents aged 12 to 17 identified as at risk during routine Well Visits. Participants will be monitored over a two-year intervention period. Researchers will track referrals to behavioral health clinicians, brief interventions delivered, initiation and engagement in specialty treatment, diagnoses related to substance use and mental health, substance use behaviors, depressive symptoms, suicidality, and health services utilization. These assessments occur at 1- and 2-year follow-ups, with specialty treatment monitored within specific timeframes after screening. The study seeks to understand which SBIRT delivery method best supports early intervention and care for adolescent substance use and mental health issues.