Severe Mental Disorder

8

Review clinical trials related to Severe Mental Disorder. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Effect of Comorbid Alcohol/Substance Use

Study Design This study was designed as a comparative, cross-sectional case-control study examining the effect of comorbid alcohol and substance use disorder (ASUD) on clinical course and social inclusion among individuals with severe mental illness followed at a Community Mental Health Center (CMHC). The study did not involve any interventions. Aim The aim of this study is to examine the effect of comorbid alcohol and substance use on clinical course parameters-such as number of hospitalizations and medication dosages-and on social inclusion indicators-such as employment, social participation, and social adjustment-among individuals with severe mental illness followed at the CMHC, in comparison with a matched control group without substance use. Research Questions What are the rates of comorbid alcohol and substance use among patients with severe mental illness followed at the CMHC? What are the current addiction symptoms, number of hospitalizations, and employment rates among individuals with severe mental illness and comorbid ASUD? What is the level of continuity of CMHC engagement and social participation among individuals with severe mental illness and comorbid ASUD, and what factors influence it? How does the level of social inclusion among individuals with severe mental illness and comorbid ASUD compare with that of individuals without ASUD? Hypotheses H1: The average annual number of hospitalizations among individuals with a dual diagnosis (severe mental illness + ASUD) followed at the CMHC is significantly higher than among those without substance use. H2: Among individuals with a dual diagnosis, the daily medication doses (e.g., chlorpromazine equivalents) required to control psychotic or manic symptoms are higher than in the control group. H3: Social inclusion is lower among patients with substance use compared with the control group. H4: Employment rates among individuals with a dual diagnosis are significantly lower than among those with severe mental illness alone. H5: Substance use negatively affects patients' social participation, including involvement in activities and friendships. H6: Attendance rates at CMHC workshops and rehabilitation programs are lower among individuals with substance use compared with the control group.

Participants needed: 297
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Abant Izzet Baysal UniversityUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Being 18 years of age or older, [+2]

Individuals diagnosed with organic brain damage or neurodevelopmental disorders... [+1]

Status: Recruiting

Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic

This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness

Participants needed: 84
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: Bjorn H. EbdrupUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

Patients with schizophrenia spectrum disorders (International classification of... [+8]

Clinical or laboratory evidence of comorbid medical disease not compatible with... [+3]

Status: Recruiting

Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)

The project focuses on patients with severe mental disorders (SMD) residing in Italian mental health supported accommodation (SA). Although the goal of SA is to promote personal recovery - that is, living life to the fullest of one's potential - international literature on this topic is scarce, and traditional treatments in the Italian residential system show limitations in adopting such approaches. The research hypothesis is that activating personal recovery pathways could improve the biopsychosocial outcomes of patients, caregivers, and professionals. To test this hypothesis, a non-pharmacological, non-randomized interventional trial will compare two groups: one group of individuals with SMD receiving recovery-oriented treatment, using the Mental Health Recovery Star, and another group of individuals with SMD receiving standard treatment. The Mental Health Recovery Star is a ten-pointed star-shaped tool that represents various life dimensions. Patients, together with their key professional, are expected to negotiate a score for each domain on the five-stage 'Scale of Change,' capturing and monitoring the different phases of the recovery process.

Participants needed: 72
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: IRCCS Centro San Giovanni di Dio FatebenefratelliUpdated: Dec 18, 2025Locations: 3
Eligibility criteria

diagnosis of a mental disorder according to DSM5TR, [+2]

moderate/severe intellectual disability, [+5]

Status: Recruiting

Norwegian Mental Illness Heart Health Study

Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population. The goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health. The main questions it aims to answer are: * Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease? * Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months? * Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable? Researchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only. During the six month program, participants in the lifestyle group will: * Meet with a clinical dietitian once a month for dietary counselling * Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan Around 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.

Participants needed: 70
Trial details
Age: 25-70Biological sex: AllType: InterventionalSponsor: Madeleine Elisabeth AngelsenUpdated: Oct 2, 2025Locations: 1
Eligibility criteria

Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder) [+2]

Inability to provide informed consent* [+15]

Status: Recruiting

Prediction and Intervention Effect of Rehabilitation Status for Severe Mental Disorder Patients Based on Multimodal Analysis and AI Agents

Mental health issues represent a major public health and social problem that significantly impacts economic and social development. Compared to other diseases, mental disorders can impair various aspects of a patient' s life, including psychological, social, occupational, and educational functions, affecting their quality of life and daily living abilities. Particularly, severe mental disorders tend to have a chronic course, often resulting in diminished social functions and social withdrawal, making it difficult for patients to integrate into society. Repeated, systematic, and comprehensive rehabilitation training for patients with severe mental disorders can effectively control or delay disease recurrence, improve social functions, enhance quality of life, and facilitate patients' reintegration into society. In recent years, the scope of mental disorder rehabilitation has expanded to include enhancing patients' social functions and promoting their integration into society. Vocational rehabilitation and social skills training are widely used in the rehabilitation treatment of patients with severe mental disorders, and some physical intervention methods, such as neurofeedback training, have also proven to be significantly effective in the rehabilitation process. However, traditional rehabilitation techniques often lack specificity and fail to meet individualized needs of patients. Additionally, the rehabilitation process lacks long-term monitoring, making it challenging to continuously assess and adjust patients' rehabilitation outcomes. Furthermore, the assessment of rehabilitation effectiveness mainly relies on patients' subjective feelings and clinical observations, lacking high-quality evidence. Therefore, there is an urgent need to introduce new rehabilitation technologies and scientifically evaluate their effectiveness to address the shortcomings of traditional methods and provide more personalized, precise, and effective rehabilitation support. With the rise of digital health technologies, the field of mental health rehabilitation has encountered new opportunities. Compared to traditional therapies, digital health is revolutionizing the healthcare industry, moving away from traditional approaches to healthcare management to real-time personalized monitoring and therapeutic care.Technologies such as remote monitoring, virtual reality, and computer-assisted cognitive correction therapy are increasingly applied in rehabilitation. However, these methods still need improvements in data management and integration capabilities. A large amount of data accumulates in systems, recording only the training process and real-time effects of patients, without further evaluating their rehabilitation status, leading to resource waste. Therefore, there is an urgent need to develop a digital rehabilitation model that better meets the genuine needs of patients with severe mental disorders. This study aims to integrate multimodal technology, reinforcement learning, and agent-based modeling (ABM) into the research of mental health rehabilitation to more accurately assess and predict the rehabilitation status of mental disorder patients and to more effectively guide and support decision-making in mental rehabilitation treatment.

Participants needed: 82
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Shanghai Mental Health CenterUpdated: Aug 17, 2025Locations: 1
Eligibility criteria

Registered in the Shanghai Mental Health Information Management System, [+2]

Status: Recruiting

A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders

The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.

Participants needed: 170
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUpdated: May 14, 2025Locations: 2
Eligibility criteria

Age >18 years [+5]

Possibility of a learning disability (IQ<75) [+7]

Status: Recruiting

Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders

This randomized-controlled trial (RCT) will investigate if digital follow-up of exercise, i.e. followup through the new citizen portal HelsaMi, coupled with an exercise app can result in exercise adherence and improved oxygen uptake in individuals with mental disorders (MD). Secondary, the project will provide information regarding effects on cardiovascular disease risk-factors, functional capacity, quality of life, satisfaction, and cost through a randomized-controlled trial (RCT) including individuals with MDs. Outcomes assessed in this project, such as maximal oxygen uptake, functional capacity, and quality of life, are strongly related to the ability to carry out activities of daily living. These outcomes are associated with benefits such as reduced sick leave, extended life expectancy, independence, and improved health status with increasing age. Economically, with the world population growing older and health care resources being stretched, there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion, preferably utilizing existing platforms and exercise apps.

Participants needed: 40
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Norwegian University of Science and TechnologyUpdated: Apr 1, 2025Locations: 1
Eligibility criteria

Individuals receiving outpatient mental health treatment at the clinics of menta... [+2]

Contraindications for exercise training and testing according to the ACSM specif... [+1]

Status: Recruiting

Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness

The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.

Participants needed: 258
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Amsterdam UMC, location VUmcUpdated: Jun 14, 2024Locations: 1
Eligibility criteria

Meet the criteria of severe mental illness [+4]

Contra-indications (to be assessed by the treating physician/psychiatrist) for p... [+3]