Clinical Research Directory

Behavioral Health Referrals Study

This is a Stepped Wedge Cluster Randomized Trial (SW-CRT) to evaluate Express Access -- a new behavioral health referral application to support PCP referrals to behavioral health therapists. The hypotheses are that clients who use Express Access for behavioral health referrals will have better overall well-being (primary outcome), as well as higher satisfaction with the referral process and faster speed to behavioral health care (secondary outcomes), than those who experience the usual standard referral processes.

Safety and Efficacy of HB-1 for Post-Traumatic Stress Disorder

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).

Harm Reduction Services

The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).

UPSIDES - Recovery Through Peer Support

Research problem and specific questions Peer support (PS) is a well-established intervention within community mental health services (CMHS) internationally, involving a person recovering from serious mental health problems (SMHP) in supporting other users. International studies have shown that PS strengthen users recovery and social inclusion but also highlight the need for larger effect studies on specific manualized interventions. Despite international research showing benefits of PS in C MHS, PS an underused type of support in Sweden. There is a urgent need for more Swedish research developing and evaluating the efficacy of PS interventions for persons recovering from SMHP and in shifting Swedish MHS towards a recovery focused model of service. In meeting this need the current project aims to evaluate the efficacy of a new manualized PS intervention, the UPSIDES-Swe, in Swedish MHS. Is the peer support intervention, UPSIDES-Swe, significantly more effective than TAU at intervention end (10 weeks) in terms of personal recovery (primary outcome)? Is UPSIDES-Swe significantly more effective than TAU post intervention and at three month followups in terms of other personal recovery aspects (secondary outcomes i.e., social inclusion, empowerment, quality of life)? Is the UPSIDES-Swe, significantly more effective than TAU post intervention and at three followups in improving secondary outcomes of clinical recovery related variables, i.e., symptoms and functioning? How well can the implementation plan and UPSIDES-Swe intervention be implemented and processes explained in relation to primary and secondary outcomes? Data and method A randomized, assessor-blinded, multi-center trial will be performed between the years 2025-2028. A total of 300 service users will be recruited, and half will be randomized to receiving a PS intervention (UPSIDES-Swe) and an equal number to TAU. A process evaluation will also be performed. Societal relevance and utilization This project will investigate if a specific PS intervention might be effective in providing greater recovery and social inclusion for a disadvantaged and largely neglected group. The Swedish National Board of Health and Welfare has also recommended that PS is a promising method but that the evidence is weak and that all implementation of PS interventions should be evaluated.

Cytisine vs Nicotine Replacement Therapy

Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco use rate has substantially gone down in the general population, significant differences exist between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the rest of the Canadian general population. This stark inequity in tobacco use translates into devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart disease and death. Canadians who are homeless or at-risk for homelessness die 25 years earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use related inequity - a novel approach is urgently needed. Despite commonly held dogma that People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led community-based action approach used in their PROMPT project has demonstrated that tobacco dependence strategies can be implemented with great success in this population. The majority of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all other drug use. Importantly, the investigators have demonstrated that it is possible to gain the trust and engagement of marginalized populations and that researchers can create a community space that is low-threshold, safe and non-judgmental. The investigators aim to compare two tobacco dependence management strategies in the homeless (or at-risk for homelessness) multi-drug use population in Ottawa and Toronto. They will use the same peer-led approach in PROMPT with community peer researchers with lived experience; with the hope that the cost-effective community based framework derived from this trial will serve as a template for interventions and treatments in community settings for chronic diseases such as obesity and diabetes.

Validation of French PHQ-4 and PC-PTSD-5 Screening Scales

Mental illness is a major public health issue. It affects one in five people, represents the largest expense for health insurance (14%), is the leading cause of years lived with disability, and suicide is the main cause of death among people aged 15 to 35. Depression affects 15 to 20% of individuals at some point in their lives. Trauma-related disorders affect 4.6% of people, including 1- 2% with post-traumatic stress disorder (PTSD). Screening for mental health problems in primary care is crucial. It enables doctors to provide early treatment, reduces the need for emergency care, and decreases both the number and duration of hospital stays. However, general practitioners and other non-mental health professionals often report lacking the time, training, and tools to conduct such screenings. Fortunately, brief and validated screening tools exist in English: The PHQ-4 (Patient Health Questionnaire-4) for anxiety and depression, and the PC-PTSD-5 (Primary Care PTSD Screen for DSM-5) for PTSD. So far, no French versions of these tools have been validated.

Efficacy and Safety of HB-1 for Panic Disorder

The purpose of this study is to determine the safety and efficacy of HB-1, versus placebo and two monotherapies, in male and female adult patients aged 18 to 65 years, inclusive, with Panic Disorder.

Successful Transitions and Reintegration Tools for Veterans (START-VETS)

This study will develop prison reentry materials for Veterans leaving prison.

Forging New Paths: Building Interventions to Treat Criminogenic Needs in Community Based Mental Health Settings

The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are: 1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure). 2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes) Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

Genetic Counselling in the Prevention of Mental Health Consequences of Cannabis Use

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. Participants will be counselled regarding their individualized risk of developing and of not developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention.

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.

Comparative Effectiveness of IIMR Versus CDSMP

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

HEAlth Dialogues for Patients With Mental Illness in Primary Care

In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications. Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling. National registries will be used for a, up to 20 year long follow-up regarding cardiovascular complications and mortality.

Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention

The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep. The main questions the study aims to answer are: * Does the ICBT program lower the self-rated suffering from mental illness? * Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days. Participants are adults living in Sweden. They will: * Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants. * Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment. Primary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.

Process and Outcome Evaluation of Different Psychotherapies

In this study, adult patients and therapists at the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.

Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms

The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' levels of depression and anxiety. Parents will respond to questionnaires administered by social workers. The level of depression and anxiety will be descriptively and statistically compared to clinical and normative samples. Additionally, statistical analyses will examine variables associated with parents\' mental health symptoms.

Exploring Empathy and Compassion Using Digital Narratives

Stories of suffering and struggle are shared continuously through digital formats such as internet videos, news stories, social marketing, and fundraising campaigns. Digital stories are often created and shared to generate awareness about a problem, impart knowledge on contemporary issues, or promote compassion. The practice of sharing critical life events and insights provided by these experiences are valuable for tellers and the listeners alike for catharsis, healing, reconciliation, and connectiveness. Portrayals of mental suffering are a matter of cultural and social interest as new media products become available to the public. Studies published since the 1990s overwhelmingly conclude that formal media depictions are biased, promoting the stereotype that people who suffer emotionally are mentally ill, dangerous, violent, or insane. Various agencies, organizations, and corporations are actively working to provide alternative stories/narratives to mainstream media by means of video testimonials in social marketing and fundraising campaigns and, ultimately, by taking advantage of the Internet. The impact of this work is under-researched. However, preliminary evaluations of social marketing campaigns report mixed results and raise questions about their effectiveness. As well, the first-person narrative prepared digitally and shared online is also providing alternative narratives to mainstream media stories. People are increasingly using digital videos to share their stories, viewing this as an opportunity to understand their emotions and thoughts, come to terms with disgrace around sensitive, personal issues and marginalization while providing hope and encouragement to others. This proposed study focuses on the process of creating digital narratives/stories, especially stories of mental and emotional suffering, and their impact in terms of inciting empathy, compassion, and good citizenship among viewers.