Mental Health Treatment

This research aims to evaluate whether taking antipsychotic medication every other day is as effective as the usual daily dosing for people with schizophrenia or related disorders. The study also explores if the alternate day dosing reduces side effects compared to daily treatment. It is a randomized, double-blind trial designed to compare these two dosing schedules over one year. Participants will be randomly assigned to either continue their current daily antipsychotic medication (risperidone, olanzapine, or paliperidone) or switch to an alternate day dosing schedule. To maintain blinding, active medication and placebo capsules are provided in matching blister packs so participants and staff cannot tell which regimen is assigned. Doses range from 1 mg to 16 mg for risperidone, 5 mg to 20 mg for olanzapine, and 3 mg to 12 mg for paliperidone. Treatment is individualized, and other psychotropic medications can continue if stable. Participants will attend 22 visits over 52 weeks, with visits every two weeks for the first six months and monthly visits for the final six months. Researchers will assess symptom severity and side effects using several scales, including the Brief Psychiatric Rating Scale and multiple symptom and wellbeing questionnaires. The main outcome focuses on clinical deterioration at the start and end of the study. Safety and medication adherence will be closely monitored throughout the trial.

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

Researchers are comparing two psychotherapy programs, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Behavioral Activation (BA), in adults with persistent depressive disorder (PDD) who have not responded well to previous treatments. This study focuses on hospitalized patients with treatment-resistant depression and aims to evaluate which therapy is more effective in reducing depressive symptoms over 16 weeks. The study also explores factors that affect treatment response and the long-term effects of these therapies. Participants will receive either CBASP or BA treatment during a 10-week acute phase consisting of inpatient or dayclinic therapy followed by a 6-week outpatient continuation phase with group therapy. Both therapies include individual and group sessions, nurse contacts, and exercise therapy during inpatient treatment. All patients will also receive optimized antidepressant medication according to standard guidelines, with adjustments if needed based on response. During the study, participants will undergo regular assessments using various depression rating scales, symptom inventories, and quality of life questionnaires from baseline through 64 weeks after treatment start. Researchers will monitor responses, remission, relapse rates, and cost-effectiveness of the treatments. The total study duration includes acute treatment, continuation therapy, and long-term follow-up to evaluate sustained outcomes and health economic impacts.

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

Veterans face a heightened risk of suicide during the first year after leaving military service, especially those not connected to VA healthcare. This research aims to improve reintegration and reduce suicide risk for recently transitioned Veterans by evaluating STEP-Home-SP, a skills-based, video telehealth workshop. It is designed to provide suicide prevention education, support for accessing VA care, and tools to manage the transition effectively during this critical period. The study compares two groups: one participating in the STEP-Home-SP workshop and the other receiving Enhanced Usual Care (EUC), which includes standard care plus an educational packet on suicide risk and VA care connection. STEP-Home-SP involves weekly 1.5-hour group sessions over 12 weeks, focusing on emotional regulation, problem solving, and attention training, with up to six additional 30-minute individual sessions tailored to each Veteran's needs. EUC involves existing transition support programs such as the Transition Assistance Program and VA Solid Start outreach. Participants will be assessed at multiple points over a year, including baseline, 12 weeks, and 24 weeks. Researchers will measure feasibility factors like recruitment and adherence, satisfaction with the program, and changes in reintegration status using the Military-to-Civilian Questionnaire. They will also monitor engagement with VA care and collect qualitative feedback. The study will help inform future larger trials and aims to address social isolation and suicide risk during Veterans' transition to civilian life.

Researchers are evaluating the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on the mental and physical health of firefighters in Tainan, Taiwan. This cluster randomized controlled trial aims to determine if the Traditional Chinese version of the HLS mobile app can improve firefighters' health compared to usual care. The study also seeks to find out whether the intervention can promote a healthier lifestyle and reduce the risk of chronic non-communicable diseases among firefighters. Participants will be randomly assigned to either the intervention group, which uses the Traditional Chinese HLS mobile app designed specifically for firefighters, or the control group, which receives usual care. The intervention period lasts from 3 to 6 months, during which firefighters in the intervention group will use the app to support healthier behaviors. The control group will continue with their standard practices without the app. Throughout the study, firefighters will undergo health and fitness assessments at the start and again 3 to 6 months after the intervention begins. Measurements include blood pressure, depressive symptoms, PTSD symptoms, body mass index, smoking habits, diet patterns, physical activity levels, sitting time, sleep duration and napping frequency, glycated hemoglobin, lipid profiles, C-reactive protein, and physical performance. The study will monitor these outcomes to assess changes in mental and physical health. Safety and progress will be observed through these regular evaluations during the study period.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

Researchers are evaluating a new psychosocial program called Hopeful and Healthy Living (HHL) to help adults over 50 with serious mental illness increase social connections and adopt healthier lifestyle habits. This pilot randomized trial compares the HHL program with usual treatment to see if it improves social support, reduces loneliness, enhances psychosocial and cognitive functioning, and promotes better sleep, activity, and diet over one year. Participants in the experimental group will join the 16-week HHL group intervention, which meets weekly for 90 minutes. The sessions focus on social skills, cognitive self-management strategies, and healthy lifestyle routines including exercise, diet, and sleep. Each class includes practice, group exercises, and personalized take-home activities. The control group continues their regular treatment without the additional program. During the study, participants complete interviews and questionnaires at the start and at 4, 8, and 12 months. Assessments include cognitive tests, social support and loneliness scales, physical activity, diet, and sleep quality measures. Researchers will analyze these outcomes to determine the impact of the HHL program compared to usual care. The study runs through July 2028 and is sponsored by Boston University Charles River Campus.

Healthcare professionals often face severe stress, which can lead to sick leave and affect their well-being. This research aims to evaluate whether a five-week internet-based compassion course can help reduce stress of conscience and work-related stress, while improving professional quality of life and self-compassion. The study compares this compassion course with a general internet-based cognitive behavioral therapy (CBT) stress management course and a waitlist group. Participants will be randomly assigned to one of three groups: a therapist-guided internet compassion course, a therapist-guided general internet CBT stress management course, or a waitlist for 10 weeks followed by the general CBT course. Both courses are structured self-help programs lasting five weeks, including weekly reports and therapist feedback delivered online. The compassion course focuses on compassion-focused therapy methods, while the CBT course uses traditional CBT techniques. Throughout the study, participants will complete assessments at baseline, 5, 10, and 15 weeks, and again at 6 months. These assessments measure changes in stress of conscience, professional quality of life, work-related stress, and self-compassion. Data are collected through self-assessment forms, and the study tracks progress over time to understand the effects of the courses. The total participation time spans up to 6 months to monitor longer-term outcomes and maintenance of benefits.

Researchers are evaluating how well esketamine nasal spray works to improve depressive symptoms in adults with treatment-resistant depression. The study focuses on participants aged 18 to 64 who have not responded to at least two oral antidepressant treatments during their current depressive episode. The main goal is to measure changes in depression severity using the Hamilton Depression Rating Scale (HAM-D) over a 4-week treatment period. Participants will self-administer esketamine nasal spray twice a week for four weeks. The dose will be flexible, either 56 mg or 84 mg, delivered as one spray into each nostril per session. For the 84 mg dose, sprays will be given in rapid succession at three different time points using three devices, while the 56 mg dose requires two devices. This open-label, single-arm study will monitor participants throughout the treatment phase. During the study, participants will be assessed regularly using the HAM-D scale and other measures such as the Patient Health Questionnaire (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scale to track changes in depressive symptoms. The primary outcome is the change in HAM-D total score from baseline to Day 28. Safety and treatment response will also be monitored. The total participation time covers the 4-week treatment phase, with evaluations at baseline and throughout the study period.