Clinical trials

The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.

The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-/post-treatment PET/MRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine \[¹⁸F\]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.

Psychiatric conditions are each defined by different set of symptoms, however, they often share common characteristics such as impairments in cognitive and social functioning. These impairments can cause significant distress and disrupt daily functioning by preventing individuals from actively participating in school or work, maintaining healthy relationships with others, and engaging in everyday activities independently. The goal of this clinical trial is to examine if action-based cognitive remediation (ABCR) therapy, a type of cognitive training program, works to treat cognitive impairments in participants with psychiatric disorders. The main questions it aims to answer are: * Whether the intervention will improve the thinking skills of participants with different types of psychiatric conditions * Whether the intervention will improve social skills and work performance * Can this program be easily used in a regular hospital, and do the people who take part in it find it helpful and worth their time * Whether the improvements from the intervention last for a long time after the training is over. Researchers will compare how much the thinking skills of participants change during an 8-week waiting period (where they get no treatment) to how much they change during the 8-week training program to see if the training makes a bigger difference in helping them think and live better. Participants will : * Complete a series of questionnaires on memory, thinking skills, and mental health at the beginning of the study * Wait 8 weeks without any intervention or training * Complete the series of questionnaires again * Complete an 8-week training intervention of ABCR where they will use special computer programs to practice real-life skills and tasks like planning a meal or making an appointment * Complete the series of questionnaires and an additional structured interview to assess acceptability and feasibility of the intervention. * 3 month later, complete questionnaires for a final time.

Individuals living with a psychotic disorder often experience changes to their thinking and social skills that can lead to challenges with work, school, relationships and living independently. One intervention to target these areas is cognitive remediation therapy, which can be delivered in virtual reality to help apply the skills and strategies learned to day-to-day life. Over the past few years, our team has co-developed a cognitive remediation program in virtual reality with healthcare professionals and people with lived experiences of psychosis. The current trial tests the feasibility and efficacy of this cognitive remediation program in virtual reality at improving thinking skills, social skills, and daily life functioning.

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, brain imaging is used to investigate the brain mechanisms underlying these cognitive deficits in these populations.

Severe and persistent mental health disorders are associated with impairments in cognitive, emotional, and social functioning. Some of these disorders involve cognitive challenges that are likely to negatively affect quality of life. In this context, the early identification of cognitive difficulties and intervention through cognitive remediation become priority therapeutic targets to facilitate individual rehabilitation. From this perspective, the present study aims to determine the relevance of a personalized cognitive remediation program developed by neuropsychologists at Pierre-Janet Hospital, called RECAMEX, to guide its sustainable adoption and to support its implementation in other clinical settings.

In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.

The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices. Study investigators also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group.

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

The importance and benefits of leading a physically active lifestyle have been long studied. Examples of the multiple advantages from physical activity are improved health of the heart and brain, having a more independent living and better quality of life. However, it is known that for many people, being active is challenging: physical activity is commonly viewed as a burden or inconvenience. In this study we will explore how some common everyday thoughts are hurdles to becoming physically active. We will discover ways to overcome this by using concepts from a field called "behavioral economics" that explains how we make decisions. The purpose of the program is to support participants in being more physically active. The study program is a newly developed way to overcome the intuitive preference for being sedentary. The experimental groups will learn simple ways to overcome expected hurdles in making decisions related to physical activity (the newly developed program), and the control groups will learn about the health benefits of physical activity and the health guidelines (the common practice today). We will compare the effectiveness of the newly developed intervention in promoting an active lifestyle, compared to the common practice today, of providing the knowledge and the recommended guidelines. The program in the study will be in small groups of 5-10 participants that will meet at The Royal for 60 minutes, twice a week, for 4 weeks.

The creation and distribution of child sexual abuse material (CSAM) is a large-scale global problem. CSAM is sometimes referred to as child pornography. It includes images, videos, live-streaming, and any other material that depicts sexual acts with a child or adolescent (i.e., a person under the age of 18). It also includes material that shows a child or adolescent in a sexually suggestive or explicit manner partially clothed, or nude, and can include material that does or does not illustrate sexual activity. CSAM use is a problem that continues to drastically increase in size despite the numerous political, police, and technological initiatives that have been put forth as solutions. Previous research also suggests that many active CSAM users desire help to stop their use, but have experienced difficulties finding support that is anonymous. Thus, there is a great need for anonymous intervention programs that assist active and at-risk CSAM users in developing skills to manage their thoughts, feelings, and behaviours related to CSAM. ReDirection is a free, anonymous, online, self-guided, cognitive behavioural therapy (CBT)-based program for individuals concerned about their use or risk to use CSAM. The treatment program is based on many years of clinical experience working with patients who have committed sexual offences, and the results of several previous research projects. This study will implement a scientifically rigorous design (a three-armed randomized waitlist-controlled trial) to evaluate two versions of this intervention (ReDirection 1.0 and ReDirection 2.0). The primary difference between the two versions of ReDirection is the length of the program and whether it includes the option for asynchronous messaging with a ReDirection specialist. The study design compares ReDirection 1.0 and ReDirection 2.0 with a waitlist control group. Participants in the waitlist control will wait six weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing about sexual urges and behaviours. Participants will be recruited directly from the ReDirection website, where they will be directed to a secure platform designed specifically for clinical trials of internet-mediated CBT. This platform is called Iterapi. Potential participants learn about the ReDirection program through advertisements on both the "Clearnet" and "Darknet." All trial activities, including participant registration, random assignment, intervention, and evaluation will be conducted via Iterapi. Treatment includes five-to-six modules over five-to-six weeks and the content includes CBT-based psychoeducation and exercises that aim to help participants gain greater understanding of, and skills to manage risky sexual thoughts, feelings, and behaviours.

Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.