Clinical Research Directory

GLP-1R Agonist Treatment for Opioid Use Disorder

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is: • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids? The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids. The participants will: * Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study

Psychological Outcomes of Strategic Therapy in Adult Outpatients (POST Trial)

This observational study investigates the outcomes of Strategic Psychotherapy, a form of brief psychological treatment focused on specific goals for change. The aim is to evaluate whether patients who receive this therapy in private practice settings experience improvements in their psychological well-being, psychological symptoms, and daily functioning. The study population includes all adult patients (≥16 years) who spontaneously seek treatment from two strategic therapists between January 2021 and December 2025. Eligible participants must present with psychological problems that meet the criteria for a clinical diagnosis. Participants will complete two psychological questionnaires (SCL-90R and CORE-OM) before starting therapy and again at the end of their treatment. Changes in scores on these outcome measures will be statistically compared with data from a non-clinical population to assess whether the observed changes are greater than would be expected by chance. Additional information will be collected, including medication use, the patient's own evaluation of the therapy, the number of sessions attended, the initial diagnosis, family involvement, and the types of therapeutic prescriptions used.

Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care

Community mental health centers (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand, there are long waiting lists and low engagement rates. Innovative interventions are urgently needed to address these challenges to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient activation and treatment satisfaction in other contexts. They may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this study aims to evaluate a digital pre-therapy patient education program tailored specifically for adults with mental disorders. This intervention aims to enhance treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes.

Expert@Work - Effectiveness of a Digital Expert Team on Return to Work

Long-term sick leave is a challenge in Norway, and the healthcare and labor- and welfare services are often not coordinated in helping the sick-listed employees return to work. In this study, the investigators want to evaluate the effectiveness of an intervention where an expert team provides advice for an individualized patient pathway based on information from a digital questionnaire and a video meeting with the sick-listed employee and the participant's general practitioner. The patient pathway should include both healthcare and labor- and welfare services measures. Sick-listed patients with musculoskeletal- and/or common mental disorders are invited to join the study. They will receive a digital questionnaire and be randomized to either treatment as usual or personalized advice from an expert team. The team will be put together based on the response from the individual's questionnaire. The investigators will evaluate the effect on return to work and the use of health care services 12 months after the intervention.

Evaluation the Efficacy "Think and Cope Positively" Program

The purpose of this study is to determine whether an integrated protocol based on cognitive behavioural therapy, positive psychology and third generation therapies is effective in improve the subjective well-being of people affected by a severe mental illness (SMI). The design of the study is a cluster randomized control trial with two arms. Experimental groups will receive 15 sessions to enhance positive emotions, optimism, adaptive coping, finding a purpose in life and sharing it with people who are important to the user. The control group will remain on a waitlist with their treatment as usual (TAU). After the control period (15 weeks), participants of the experimental groups have the chance to receive the intervention. Both groups will be measure before and after de 15 intervention weeks. Additionally, follow-up measures of the experimental group will be taken after 3 and 6 months.

Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

Testing a Transdiagnostic TMS Treatment Target

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

AgingUP: A Pilot Program to Reduce Self-Ageism and Self-Stigma in Older Adults With Severe Mental Illness

The goal of this pilot clinical trial is to learn whether AgingUP, a 10-session psychosocial program, helps reduce self-ageism and self-stigma and fosters more positive and realistic views of aging in older adults (≥50 years) living with severe mental illness. The main questions it aims to answer are: * Does participation in AgingUP reduce self-directed ageism compared to usual care? * Does it reduce internalized stigma related to mental illness? * Does it increase self-compassion? * Does it improve their perception of their own aging? Researchers will compare the AgingUP group with a control group receiving treatment as usual to see if participants in AgingUP show more adaptive perceptions of aging and self-concept. Participants will: * Attend 10 weekly group sessions (60-75 min each) focused on cognitive-behavioral techniques, acceptance and commitment strategies, self-compassion exercises, and empowerment (as a transversal element). * Complete brief questionnaires about their experiences and attitudes before and after the program.

Individualized Functional Connectivity Targeting in aiTBS for Depression

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements.

Virtual Menstrual Pain Approaches in Females

This research study is testing two self-care approaches that may help prevent or reduce period pain in young females with recurrent painful menstrual cramps. Participants will be placed by chance into 1 of 3 groups: auricular acupressure, Baduanjin qigong, or a self-care education comparison group. The auricular acupressure and Baduanjin groups will receive online training and then practice the treatment on their own for 12 weeks. The main question is whether these two approaches can reduce the severity of menstrual pain. The study will also look at whether they can improve other symptoms that often happen with period pain, such as tiredness, poor sleep, anxiety, low mood, trouble concentrating, and reduced physical function. Researchers will also study stool and blood-related biological markers to better understand whether changes in gut bacteria and body metabolism may be linked to symptom improvement. A total of 145 participants will take part in the study at NTU, and any side effects or other safety concerns will be checked every week.

Peer-based Recovery Program

Recovery-oriented services are currently the mainstream in the field of mental health around the world. Peer services are an alternative service option promoted by recovery advocates. Western countries have invested abundant resources in promoting peer services and providing training for peer support workers. However, peer services in Taiwan have just started. More resources need to be added to make mental health services catch up with the world trend so that people with mental illness in Taiwan can have more choices. Hence, this study aims to investigate the effectiveness of the Grow to Recovery program-Short Version co-led by a peer.

The Feasibility of the Peer-based Recovery Program

Recovery-oriented services are currently the mainstream in the field of mental health around the world. Peer services are an alternative service option promoted by recovery advocates. Western countries have invested abundant resources in promoting peer services and providing training for peer support workers. However, peer services in Taiwan have just started. More resources need to be added to make mental health services catch up with the world trend so that people with mental illness in Taiwan can have more choices. Hence, this study aims to investigate the feasibility of the Grow to Recovery program-Short Version co-led by a peer.

Project Yes+ for Young MSM Living With HIV in Vietnam

In Vietnam, adolescent and young men who have sex with men (AYMSM) are among those most affected by HIV, and they also experience significant HIV-related mental health and stigma challenges. The study team proposes to adapt Project YES+ to address both mental health and internalized HIV stigma among AYMSM living with HIV in Vietnam. This research will build local capacity and develop networks for collaborative research on mental health and stigma in this population between Vietnam, Zambia and the United States.

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence

The study assesses the potential of using computational models, specifically large language models, to simulate psychotherapeutic sessions, aiming to improve therapy outcomes and advance therapist training through innovative technology.

Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study

This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya. The investigators will tailor a collaborative care model for peripartum women with HIV experiencing mental health symptoms and evaluate its impact on participants' mental health, antenatal, and HIV care outcomes. The investigators will actively engage key stakeholders throughout the process and assess scalability and sustainability through multi-method approaches. This study will contribute to the overall goal of achieving optimal health outcomes for women living with HIV and their families in sub-Saharan Africa.

Enhancing Immune Health Randomized Controlled Trial

This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.

Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.

ACT for HIV-Positive Men

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

Improving Cognition of Older Adults in Community Housing

The I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience. We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.

Study on the Effectiveness of Journaling as an add-on to Cognitive Behavioral Therapy

The aim of the present study is to examine the effects of keeping a therapy journal (journaling) on the effectiveness of cognitive behavioral therapy (CBT). Homework assignments are a fundamental component of behavioral therapies. In line with the learning theory foundation of behavioral therapies, various types of homework are used to facilitate learning processes between therapy sessions and to enable patients to make progress. One way to enhance individual goal setting and reflection in patients is through the use of "therapy journals." The goal of the planned project is to evaluate the effectiveness of goal-oriented journal writing as an additional element in cognitive behavioral therapy (CBT). To do this, psychotherapy patients will be randomly assigned to two treatment groups: CBT vs. CBT + Journaling. Patients will be block-randomized until 40 patients have completed the study in each treatment arm (at least 10 completed sessions).

Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.

Brain Stimulation to the Hippocampus in Schizophrenia

Schizophrenia - marked by delusions, hallucinations, and cognitive deficits - causes the most disability of any mental health condition, but existing treatments have significant side effect burden and are often ineffective. Disordered neural activity in the hippocampus likely contributes to schizophrenia symptoms, but to develop better therapies we need to understand whether hippocampal activity in schizophrenia can be systematically affected by non-invasive brain stimulation techniques like transcranial magnetic stimulation (TMS). This proposal will investigate the use of connectivity-guided theta burst brain stimulation to specifically target hippocampal function in schizophrenia, offering insights into fundamental hippocampal processes, schizophrenia pathophysiology, and potential avenues to use brain stimulation as a therapeutic tool in this devastating illness.

Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition. With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence. The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.