Clinical Research Directory

Digital Navigators for Acceptance and Competence Development With Mental Health Apps

The goal of this clinical trial is to learn if and how so called "Digital Navigators" (DN) can help general practitioners, outpatient psychiatrists and psychologists as well as their treated patients to use digital mental health apps (DiGAs) and integrate it into their treatment. The main questions it aims to answer are: * What are the chances and implementation barriers of DN? * What are the acceptance and expectations towards DN? * Do DN affect the psychological health of patients? * Do DN affect the digital health literacy and technical competence of participants? Employees of medical teams (e.g. medical assistants) receive training to become a DN. Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder.

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.

A Trial of Two Universal Programs for Parents of Teenagers

Group-based and internet-delivered parenting programs may help parents improve their communication and relationships with their children. However, relatively little is known about how well such programs work for parents of adolescents, because most previous studies have focused on younger children or on families selected because of elevated risk. This study evaluated two universal preventive parenting programs for parents of adolescents: the group-based ABC-Teen program and the internet-delivered ParentWeb program. Both programs were developed in Sweden and aim to promote adolescent well-being by strengthening parenting practices and parent-adolescent relationships and reducing negative communication. Families were randomized to ABC-Teen, ParentWeb, or a waitlist control condition. The sole primary outcome was parent-reported adolescent mental health problems, measured using the Strengths and Difficulties Questionnaire Total Difficulties score. Secondary outcomes included parental mental health and stress, parenting behaviors and parental self-efficacy, parent-adolescent and family relationships, adolescent school adjustment and substance use, and outcomes reported by participants in an optional adolescent survey. Parent and adolescent assessments were conducted at baseline, 4 months, and 12 months. After completion of the 4-month assessment, families assigned to the waitlist were offered their choice of ABC-Teen or ParentWeb. Consequently, comparisons with the waitlist were restricted to the period from baseline to 4 months, whereas longer-term analyses compared ABC-Teen with ParentWeb.

A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported internet-based cognitive behavioral therapy (iCBT) in Swedish primary care. Feasibility was assessed in terms of recruitment, intervention completion, and patient satisfaction. Symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion were assessed as secondary outcomes.

Healthy ReStart Intervention to Improve Health and Functioning

This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.

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.

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

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.

Screening to Identify Parents in Need of Mental Health Support: A Feasibility Study in Child Welfare Services

The main aim of this study is to evaluate the feasibility, preliminary effects and experiences of the Collaboration-Screening-Referral approach (in Swedish: Samverkan-Screening-Hänvisning - SSH) when used with parents referred to the Swedish child welfare services. The SSH is an approach to screen parents for symptoms of mental illness using structured questionnaires, establish intra-agency collaboration, and refer to mental health services. Additionally, to increase social workers and competence in assessing and handling mental illness through receiving training in the SSH and administering the screening to parents. The main questions the project aims to answer are: * Are parents engaged with child welfare services willing to undergo screening for symptoms of depression and anxiety? * How have the implementation of the SSH proceeded and to what degree is it sustained? * How do parents and social workers experience the SSH? * Do social workers' behaviors, knowledge and competence relevant to supporting parents with mental illness increase when implementing the SSH? Social workers answer questions before and after their training and after 6 and 12 months. Additionally, social workers and parents will be interviewed. Qualitative and quantitative within-group analyses will be conducted to examine experiences and preliminary effects of the SSH.

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.

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.

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.

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.

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.

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.

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.