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75 active trials for Depression, Anxiety

PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics

During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints. The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors). The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions: Can these tools be used in the community care of mental health problems during pandemics? Are they acceptable to patients? Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? Do family practitioners value patient information sent to them at the end of the trial

Start: October 2020
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design

The overarching goals of this project are to provide the first rigorous test of a scalable and publicly accessible mobile health intervention (IntelliCare) to address emotional distress in women with breast cancer, and to test the impact of human coaching as a way to increase engagement with digital health interventions to improve outcomes. To achieve these goals, an innovative experimental study design, known as a Sequential, Multiple Assignment, Randomized Trial (SMART), will be used to test the effects of the IntelliCare apps on symptoms of depression and anxiety, as well as the added value of human support to improve participant engagement for those with low levels of engagement. 313 breast cancer survivors diagnosed within the past 5 years and who screen positive for elevated symptoms of depression and/or anxiety will be recruited. Participants will initially be randomized to receive the IntelliCare apps or app-delivered patient education (control) for 8 weeks, and the impact of the IntelliCare apps on reducing symptoms of depression and anxiety in breast cancer survivors relative to control will be tested (Aim 1). Participants who receive the IntelliCare apps will be classified as high-engagers or low-engagers based on 1-week app usage patterns. High-engagers will continue to use the apps normally (i.e., no change). The low-engagers will be re-randomized to either receive added coaching vs. not (i.e., no change) in addition to the apps. The hypothesis is that added coaching to address barriers to app usage will lead to greater engagement with the apps (Aim 2). Finally, semi-structured exit interviews will be conducted with participants that receive the IntelliCare apps and coaching. Interviews will capture survivors' perceptions about the extent to which, and how, tailoring the apps and coaching specifically for breast cancer survivors may improve intervention outcomes and engagement (Aim 3).

Start: May 2021
Habits of Gamers Study

Rationale: Mindfulness is a popular therapeutic strategy that has a growing body of evidence suggesting it can improve a wide range of physical and psychological symptoms. Yet, confusion exists as to why mindfulness is effective as well as the most effective ways in which to teach and practice mindfulness. The present study will test a mindfulness training protocol to better understand the most effective ways to teach and practice mindfulness. Intervention: A group of video game players, or "gamers", will be instructed on how to play a video game of their choice in a more mindful way and compare this to an activity of daily functioning (i.e., folding laundry). Outcomes from self-report measures taken both before and after study activities will be tested against a control group of gamers who will perform the same study activities without the mindfulness induction. Objective or Purpose: The purpose of the present study is to test the effects of a brief, standardized mindfulness prompt in order to better understand effective ways to train mindfulness concepts. The mindfulness prompt will be applied to an intrinsically motivated activity (i.e., video game play for experienced gamers) and an activity of daily functioning (i.e., laundry folding) in order to evaluate the different effects of mindfulness practice when implemented with a popular leisure activity versus a less engaging activity of daily living. Study Population: This study will include adult "gamers" ages 18-65. A gamer is someone who engages in some form of digital video game play for a minimal average of three hours per week. A pre-screening measuring will rule out any participants who do not play video games with enough frequency to be considered a gamer. Study sessions will take place remotely overseen via a Zoom-based video call with study personnel. Another exclusion criteria will be an inability to speak with study personnel via Zoom or do not have a private area to perform the study activities. Study Methodology: To address the aims of this study a mixed-method, between- and within-group, counterbalanced study design will be employed. Thus, participants will be randomized to either a mindfulness or control condition with pre- and post-study-task self-report measures collected at two separate study sessions in order to statistically analyze the study hypotheses. Study Aims: The present study has one primary aim and several secondary aims: The primary aim is to test the beneficial effects of a standardized, brief mindfulness induction prior to the completion of two different activities (i.e., play a video game or fold laundry). A secondary aim is to evaluate the impact that the type of activity has on one's ability to practice mindfulness. In addition to the primary and secondary aims, an exploratory analysis will be utilized in order to better understand what factors may have mediated the results from the first two aims. Study Outcomes or Endpoints: A main effect will be used to test the differences between the study manipulation (i.e., mindfulness prompt) and control (i.e., perform the task as you usually do) conditions. The primary outcome will be a self-reported state-mindfulness scale that measures the degree to which one "mindfully" performed a specific activity. Secondary outcomes will capture changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities. Follow-up: No follow-up is planned at this time. A baseline screening measure as well as in-session pre and post-study task questions will be the only data collected. Statistics and Plans for Analysis: For the primary aim of the study, a repeated measures multivariate analysis of variance (MANOVA) with a 2 (study group) X 2 (activity type) X 2 (state mindfulness) matrix. The second study aim will be tested with a repeated measures multivariate analysis of covariation (MANCOVA) with the covariates of changes in emotions from pre- to post-activity, level of engagement or "flow" during the activity, enjoyment performing study activities, and level of focus/concentration during study activities.

Start: August 2020