GPS Exploration for Depression
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must not be taking: Antipsychotics
Disqualifiers: Head trauma, Seizures, Neurological disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking antipsychotic medication.
What data supports the effectiveness of the treatment Modifying Exploration for depression?
Training programs for General Practitioners (GPs) have been shown to improve the process of care and patient outcomes in depression treatment, suggesting that enhancing the way depression is managed can lead to better results.
12345Is GPS Exploration for Depression safe for humans?
The research articles provided do not contain specific safety data for GPS Exploration for Depression or similar treatments like Modifying Exploration. Therefore, there is no relevant safety information available from these sources.
678910How does the GPS Exploration for Depression treatment differ from other treatments for depression?
The GPS Exploration for Depression treatment is unique because it likely involves using advanced mapping techniques similar to those used in deep brain stimulation (DBS) for movement disorders. These techniques help visualize and optimize treatment settings, potentially offering a more personalized and precise approach compared to traditional depression treatments.
1112131415Eligibility Criteria
This trial is for individuals willing to share emotional and cognitive data via smartphone, including using a GPS tracking app for four months. They must consent to an FMRI scan and respond to daily texts about their emotions. It's not suitable for those with head trauma, neurological disorders, severe medical conditions, pregnancy, or history of severe substance abuse.Inclusion Criteria
I am willing to use a GPS tracking app on my phone for four months.
Must be willing to have a functional Magnetic Resonance Imaging (FMRI) scan
Must agree to give informed consent
+1 more
Exclusion Criteria
Pregnancy
You have medical conditions that make it difficult to have an MRI scan.
I do not have any severe or unstable health conditions.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants will be asked to modify their levels of exploration using smartphone technology to capture emotional and cognitive data
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to understand the relationship between real-world behaviors, thoughts, emotions, and brain activity by monitoring participants through smartphone technology that tracks location and captures emotional responses.
1Treatment groups
Experimental Treatment
Group I: Modifying ExplorationExperimental Treatment1 Intervention
Individuals will be asked on certain days to increase their levels of exploration, and some days be asked to decrease their levels of exploration. Participants will do this for up to six months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiCoral Gables, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
GPs' views on the use of depression screening and GP-targeted feedback: a qualitative study. [2022]The first aim of this qualitative study was to identify general practitioners' (GPs') views on depression screening combined with GP-targeted feedback in primary care. The second aim was to determine the needs and preferences of GPs with respect to GP-targeted feedback to enhance the efficacy of depression screening.
[Views of patients diagnosed with depression and cared for by general practitioners and psychiatrists]. [2021]To explore the experiences of patients treated for depression either by general practitioners (GPs) or psychiatrists (Ps) with the aim of identifying improvement strategies.
Are effects of depression management training for General Practitioners on patient outcomes mediated by improvements in the process of care? [2015]Depression treatment by General Practitioners (GPs) and patient outcomes improved significantly after a comprehensive 20-h training program of GPs. This study examines whether the effects on patient outcomes are caused by the improvements in the process of care.
[Improving care for depressed patients: what is added by GP's meetings?]. [2018]To show what French GP's have to say about their management of depressed patients, and how to improve it.
[Improved recognition and treatment of depression with occasional faster recovery through postgraduate training of family practitioners]. [2015]To examine to what extent postgraduate training of general practitioners (GPs) with the Intervention Study Primary Care (INSTEL) programme improved detection, diagnosis, and treatment of depression, and whether the course of depression was influenced favourably.
Monitoring product safety in the postmarketing environment. [2021]The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.
Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. [2022]To evaluate the performance of a trigger tool for identifying adverse drug events (ADEs) among older adults in ambulatory primary care practices.
Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. [2022]In clinical trials, harms (i.e., adverse events) are often reported by simply counting the number of people who experienced each event. Reporting only frequencies ignores other dimensions of the data that are important for stakeholders, including severity, seriousness, rate (recurrence), timing, and groups of related harms. Additionally, application of selection criteria to harms prevents most from being reported. Visualization of data could improve communication of multidimensional data. We replicated and compared the characteristics of 6 different approaches for visualizing harms: dot plot, stacked bar chart, volcano plot, heat map, treemap, and tendril plot. We considered binary events using individual participant data from a randomized trial of gabapentin for neuropathic pain. We assessed their value using a heuristic approach and a group of content experts. We produced all figures using R and share the open-source code on GitHub. Most original visualizations propose presenting individual harms (e.g., dizziness, somnolence) alone or alongside higher level (e.g., by body systems) summaries of harms, although they could be applied at either level. Visualizations can present different dimensions of all harms observed in trials. Except for the tendril plot, all other plots do not require individual participant data. The dot plot and volcano plot are favored as visualization approaches to present an overall summary of harms data. Our value assessment found the dot plot and volcano plot were favored by content experts. Using visualizations to report harms could improve communication. Trialists can use our provided code to easily implement these approaches.
On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. [2021]Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration Adverse Event Reporting System as well as electronic medical record systems provide crucial information to evaluate postmarketing drug safety. In this article, we assess the strengths and limitations of Food and Drug Administration Adverse Event Reporting System and electronic medical record data in studying the postmarketing pharmacovigilance outcomes for 12 selected antidepressant drugs. In addition, we evaluate the consistency of the results obtained from these two data sources, and provide potential directions for evidence integration.
A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. [2023]Adverse event (AE) data in randomized controlled trials (RCTs) allow quantification of a drug's safety risk relative to placebo and comparison across medications. The standard US label for Food and Drug Administration-approved drugs typically lists AEs by MedDRA Preferred Term that occur at ≥ 2% in drug and with greater incidence than in placebo. We suggest that the drug label can be more informative for both patients and physicians if it includes, in addition to AE incidence (percent of subjects who reported the AE out of the total subjects in treatment), the absolute prevalence (percent of subject-days spent with an AE out of the total subject-days spent in treatment) and expected duration (days required for AE incidence to be reduced by half). We also propose a new method to analyze AEs in RCTs using drug-placebo difference in AE prevalence to improve safety signal detection.
Therapeutic maps for a sensor-based evaluation of deep brain stimulation programming. [2021]Programming in deep brain stimulation (DBS) is a labour-intensive process for treating advanced motor symptoms. Specifically for patients with medication-refractory tremor in multiple sclerosis (MS). Wearable sensors are able to detect some manifestations of pathological signs, such as intention tremor in MS. However, methods are needed to visualise the response of tremor to DBS parameter changes in a clinical setting while patients perform the motor task finger-to-nose. To this end, we attended DBS programming sessions of a MS patient and intention tremor was effectively quantified by acceleration amplitude and frequency. A new method is introduced which results in the generation of therapeutic maps for a systematic review of the programming procedure in DBS. The maps visualise the combination of tremor acceleration power, clinical rating scores, total electrical energy delivered to the brain and possible side effects. Therapeutic maps have not yet been employed and could lead to a certain degree of standardisation for more objective decisions about DBS settings. The maps provide a base for future research on visualisation tools to assist physicians who frequently encounter patients for DBS therapy.
Stimulation maps: visualization of results of quantitative intraoperative testing for deep brain stimulation surgery. [2021]Deep brain stimulation (DBS) is an established therapy for movement disorders such as essential tremor (ET). Positioning of the DBS lead in the patient's brain is crucial for effective treatment. Extensive evaluations of improvement and adverse effects of stimulation at different positions for various current amplitudes are performed intraoperatively. However, to choose the optimal position of the lead, the information has to be "mentally" visualized and analyzed. This paper introduces a new technique called "stimulation maps," which summarizes and visualizes the high amount of relevant data with the aim to assist in identifying the optimal DBS lead position. It combines three methods: outlines of the relevant anatomical structures, quantitative symptom evaluation, and patient-specific electric field simulations. Through this combination, each voxel in the stimulation region is assigned one value of symptom improvement, resulting in the division of stimulation region into areas with different improvement levels. This technique was applied retrospectively to five ET patients in the University Hospital in Clermont-Ferrand, France. Apart from identifying the optimal implant position, the resultant nine maps show that the highest improvement region is frequently in the posterior subthalamic area. The results demonstrate the utility of the stimulation maps in identifying the optimal implant position. Graphical abstract.
Monitoring gait at home with radio waves in Parkinson's disease: A marker of severity, progression, and medication response. [2023]Parkinson's disease (PD) is the fastest-growing neurological disease in the world. A key challenge in PD is tracking disease severity, progression, and medication response. Existing methods are semisubjective and require visiting the clinic. In this work, we demonstrate an effective approach for assessing PD severity, progression, and medication response at home, in an objective manner. We used a radio device located in the background of the home. The device detected and analyzed the radio waves that bounce off people's bodies and inferred their movements and gait speed. We continuously monitored 50 participants, with and without PD, in their homes for up to 1 year. We collected over 200,000 gait speed measurements. Cross-sectional analysis of the data shows that at-home gait speed strongly correlates with gold-standard PD assessments, as evaluated by the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III subscore and total score. At-home gait speed also provides a more sensitive marker for tracking disease progression over time than the widely used MDS-UPDRS. Further, the monitored gait speed was able to capture symptom fluctuations in response to medications and their impact on patients' daily functioning. Our study shows the feasibility of continuous, objective, sensitive, and passive assessment of PD at home and hence has the potential of improving clinical care and drug clinical trials.
Assessment of Parkinson disease manifestations. [2022]Parkinson disease (PD) is a progressive neurologic condition that causes motor and nonmotor manifestations. Treatment provides symptomatic benefit but no current treatment has been proven to slow disease progression. Research studies of PD require a means of rating the severity of disease by measurement of motor manifestations, assessment of ability to perform daily functional activities, and symptomatic response to medication. The most common rating scales are the Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr staging, and the Schwab and England rating of activities of daily living. Each of these rating scales are described, including detailed instructions on how to implement these ratings. Although these are the most widely applied rating scales of PD, there are still substantial limitations to these scales that must be considered when using them for research. Finally, some common applications of these scales are described.
Clinical Assessments in Parkinson's Disease: Scales and Monitoring. [2022]Measurement of disease state is essential in both clinical practice and research in order to assess the severity and progression of a patient's disease status, effect of treatment, and alterations in other relevant factors. Parkinson's disease (PD) is a complex disorder expressed through many motor and nonmotor manifestations, which cause disabilities that can vary both gradually over time or come on suddenly. In addition, there is a wide interpatient variability making the appraisal of the many facets of this disease difficult. Two kinds of measure are used for the evaluation of PD. The first is subjective, inferential, based on rater-based interview and examination or patient self-assessment, and consist of rating scales and questionnaires. These evaluations provide estimations of conceptual, nonobservable factors (e.g., symptoms), usually scored on an ordinal scale. The second type of measure is objective, factual, based on technology-based devices capturing physical characteristics of the pathological phenomena (e.g., sensors to measure the frequency and amplitude of tremor). These instrumental evaluations furnish appraisals with real numbers on an interval scale for which a unit exists. In both categories of measures, a broad variety of tools exist. This chapter aims to present an up-to-date summary of the most relevant characteristics of the most widely used scales, questionnaires, and technological resources currently applied to the assessment of PD. The review concludes that, in our opinion: (1) no assessment methods can substitute the clinical judgment and (2) subjective and objective measures in PD complement each other, each method having strengths and weaknesses.