Anxiety Clinical Trials in Canada

New challenges, stressors, and a loss of support often accompany the transition from adolescence to adulthood. Not surprisingly, transitional-aged youth (TAY) between the ages of 18-25 experience some of the highest rates of mental distress. However, access to mental health services diminish for TAY due to gaps in care when transitioning from pediatric to adult services. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth already access mental health services less frequently and face longer wait times than those in more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. Novel, innovative approaches are urgently needed to support TAY in Northwestern Ontario. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while TAY are waiting for mental health services. Read Less

The demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. The disease itself, the adjustment to a chronic/fatal diagnosis, and the treatment options can all perpetuate the development of mental illness. Despite the well-established association, there have been barriers to access suitable treatment for these patients. Online Psychotherapy is an effective treatment option that may address many of these barriers. This modality has been proven effective in addressing depression and anxiety in other populations. To date, there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge. The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for online delivery of e-CBT, developed by the PI. The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder. The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy (CBT) and Mindfulness techniques delivered via a series of modules. They will receive individualized feedback from a trained therapist weekly. It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence. The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population. Read Less

Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly. This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention. Read Less

Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for an MRI. Objectives: The aims of this study are two-fold: 1- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 2- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to address the feasibility and acceptability of the use of virtual reality. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CHU Sainte-Justine's, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics, measures of anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological biomarkers of anxiety such as alpha-amylase and other markers such as heart rate and head deviation will also be measured. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Discussion: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. It will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI. Read Less

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. Read Less

Students within post-secondary education settings are experiencing increasing stress, distress, and mental health difficulties. Many post-secondary education settings have identified student mental health and wellbeing as a priority and yet are struggling to adequately meet the needs of students. This has led to exploring whether technology can be used to help promote mental health and wellbeing among students. The JoyPop app is one mobile mental health app with a growing evidence base. It was developed to support improved emotion regulation - a key challenge among students struggling with distress and mental health difficulties. Using a randomized controlled trial (RCT) design, the primary objective of this research is to determine the effectiveness of the JoyPop app in improving emotion regulation among post-secondary students when compared to no intervention. The secondary objectives are to: (1) Assess change in mental health, wellbeing, and resilience between students in each condition to better understand the app's broader impact; (2) Conduct an economic analysis to determine whether receiving the app reduces other health service use and associated costs; (4) Assess students' perspective on the quality of the JoyPop app. Read Less

Background: Magnetic resonance imaging (MRI) has been known for almost forty years to generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI to be repeated with sedation. Very few studies seemed to have looked at the effect of virtual reality (VR) on anxiety in children scheduled for an MRI and how to identify which children are more responsive. Objective: The aims of this study are three-fold: 1- to develop an algorithm of predictability based on biofeedback; 2- to address feasibility and acceptability of a pre-procedural immersive VR (IVR) game preparation for anxiety management during MRIs and 3- to examine the efficacy of IVR game preparation compared to usual care for the management of procedural anxiety during MRIs. Methods: This study will first consist of a field test phase with 10 participants, aged 7 to 17 years old, to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. Following the field test, a RCT will be completed using a parallel design with two groups: 1) experimental group (pre-procedural IVR game preparation), 2) usual care group (standard care as per radiology department's protocol) in an equal ratio of 49 participants per group for a total of 98 participants. Recruitment will be done at CIUSSS de l'Est de l'Île de Montréal, Quebec, Canada. The experimental group will receive a pre-procedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI. Participants will complete a questionnaire to assess the acceptability, feasibility and incidence of side effects related to the intervention and the biofeedback device. Data collected will include socio-demographic, clinical characteristics and measures of procedure related-anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (STAIC-F) and the Child Fear Scale (CFS, 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature and muscle tension. Measures of healthcare professionals, parents, and participants' level of satisfaction will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a significance level (α) of 0.05. Conclusions: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a non-pharmacological therapeutic modality for anxiety management in children scheduled for an MRI. Read Less

Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up). Read Less

The study will examine the efficacy of an internet-based cognitive behavioural therapy (iCBT) for Inflammatory Bowel Disease (IBD) intervention to reduce stress, anxiety, and depression in individuals with IBD and comorbid clinically elevated t anxiety and/or depressive symptoms. The investigators will conduct a two-arm RCT comparing participants receiving the iCBT intervention (intervention group) and those receiving Treatment As Usual (TAU). Read Less