GPS Exploration for Depression

Overseen By Aaron S Heller, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Antipsychotics

Disqualifiers: Head trauma, Seizures, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the link between people's daily movements and their thoughts, feelings, and brain activity using smartphone GPS technology. Participants will change their exploration habits, such as trying new places or sticking to familiar ones, over six months. This process is called "Modifying Exploration." The trial seeks individuals who can use a GPS app on their phone, respond to daily texts about their emotions, and are comfortable with undergoing a brain scan (FMRI). This study may suit those curious about the connection between their daily routines and emotions and who do not have a history of head injuries or certain mental health conditions. As an unphased trial, it offers a unique opportunity for participants to explore the connection between their daily activities and emotional well-being.

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 prior data suggests that this method is safe for participants?

Research on how depression affects exploration remains in its early stages. However, studies have examined how individuals with mood disorders like depression explore and make decisions. These studies suggest that depression can alter how people try new things and make choices. For instance, someone with depression might be less inclined to try new activities or change behavior based on rewards.

One study examined how mood disorders impact exploration and decision-making. It found that people with depression might struggle to make stable decisions and respond to rewards. This suggests they might not react as expected to new situations or incentives.

Regarding safety, this trial uses smartphone technology to study behaviors and thoughts. It involves no medications or invasive procedures, indicating a low-risk profile. Since this trial is in an early phase, the treatment is still being tested for safety and effectiveness. Always consult a healthcare provider for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GPS Exploration for Depression trial because it explores a new way to tackle depression through behavior modification. Unlike traditional treatments that often involve medication like SSRIs or therapy sessions, this method focuses on adjusting daily exploration behaviors. The idea is to have participants vary their level of exploration—sometimes increasing and sometimes decreasing it—which could offer a novel, non-medication-based strategy for managing depression. This approach is intriguing because it could empower individuals to actively engage in their mental health management by altering their daily routines, potentially leading to improved mental well-being without the side effects of medication.

What evidence suggests that modifying exploration is effective for depression?

Research has shown that digital tools can help treat depression. These tools include techniques known as cognitive restructuring, which can lessen depression symptoms. In this trial, participants will engage in Modifying Exploration, where they will increase their levels of exploration on certain days and decrease them on others. Studies suggest that changing daily habits, such as exploring new things, can affect mood and mental health. Overall, using technology to monitor and influence behavior could be a promising way to manage depression. ^{6 7 8 9 10}

Who Is on the Research Team?

Aaron S Heller, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Modifying Exploration

Trial Overview 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.

How Is the Trial Designed?

Group I: Modifying Exploration Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Effective measurement of Parkinson's disease (PD) requires both subjective assessments (like rating scales and questionnaires) and objective evaluations (using technology-based devices) to capture the complexity of the disorder.

No single assessment method can replace clinical judgment, and combining subjective and objective measures provides a more comprehensive understanding of a patient's disease state, as each has its own strengths and weaknesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Assessments in Parkinson's Disease: Scales and Monitoring. Bhidayasiri, R., Martinez-Martin, P.[2022]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

A new method using therapeutic maps was developed to visualize the response of intention tremor in multiple sclerosis patients during deep brain stimulation (DBS) programming, allowing for more systematic and objective decision-making.

These maps combine data on tremor acceleration, clinical ratings, electrical energy delivered, and potential side effects, which could standardize the DBS programming process and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic maps for a sensor-based evaluation of deep brain stimulation programming. Bremm, RP., Berthold, C., Krüger, R., et al.[2021]

A qualitative study involving nine general practitioners in Hamburg revealed that while GPs have concerns about depression screening affecting the doctor-patient relationship, they also recognize its benefits, such as identifying undetected cases and easing their workload.

Standardized feedback on screening results was seen as valuable by GPs, who preferred concise and visually engaging materials, indicating that tailored support could enhance the effectiveness of depression screening in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GPs' views on the use of depression screening and GP-targeted feedback: a qualitative study. Braunschneider, LE., Lehmann, M., Magaard, JL., et al.[2022]

A study involving 31 patients with depression revealed that their experiences and perceptions of care are heavily influenced by their social contexts and prior interactions with healthcare services, highlighting the importance of these factors in treatment.

Patients expressed a need for better collaboration between general practitioners and psychiatrists, as well as improvements in the availability of time and psychotherapy, suggesting that addressing these areas could enhance the quality of depression care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Views of patients diagnosed with depression and cared for by general practitioners and psychiatrists]. Calderón Gómez, C., Retolaza Balsategui, A., Payo Gordon, J., et al.[2021]

A 20-hour training program for General Practitioners (GPs) significantly improved patient outcomes in 174 patients with major depression, with specific interventions like adequate antidepressant treatment accounting for a substantial portion of this improvement.

The combination of effective antidepressant treatment and strong communication skills from GPs was the most influential factor in enhancing patient outcomes, highlighting the importance of both clinical and interpersonal skills in depression management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are effects of depression management training for General Practitioners on patient outcomes mediated by improvements in the process of care? van Os, TW., van den Brink, RH., Tiemens, BG., et al.[2015]

French general practitioners (GPs) face significant challenges in managing depressed patients, including difficulties in diagnosing depression due to patient denial and complex health issues, as well as treatment barriers like poor acceptance of antidepressants and limited access to psychotherapy.

There is a need for improved communication and collaboration between GPs and psychiatrists to enhance the quality of care for depressed patients, suggesting that tailored recommendations should consider the unique context of primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improving care for depressed patients: what is added by GP's meetings?]. Cogneau, J., Liard, F., Pouchain, D.[2018]

Postgraduate training for general practitioners (GPs) through the INSTEL program significantly improved the detection and diagnosis of depression among patients, particularly for GPs who had not previously engaged in psychiatric research.

While treatment for depression improved for patients in both groups of GPs, the training led to a slight but not always statistically significant acceleration in recovery for patients with recent onset depression, indicating potential benefits of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improved recognition and treatment of depression with occasional faster recovery through postgraduate training of family practitioners]. Ormel, J., Tiemens, BG., van Os, TW., et al.[2015]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

A novel radio device used in participants' homes can objectively assess Parkinson's disease severity and progression by continuously monitoring gait speed, providing over 200,000 measurements from 50 individuals over a year.

At-home gait speed measurements correlate strongly with traditional clinical assessments and are more sensitive in tracking disease changes and medication responses, suggesting this method could enhance patient care and clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring gait at home with radio waves in Parkinson's disease: A marker of severity, progression, and medication response. Liu, Y., Zhang, G., Tarolli, CG., et al.[2023]

Visualizing adverse events in clinical trials using methods like dot plots and volcano plots can enhance communication about the severity, timing, and recurrence of harms, rather than just counting occurrences.

The study analyzed individual participant data from a randomized trial of gabapentin for neuropathic pain, demonstrating that effective visualizations can help stakeholders better understand the multidimensional nature of harms in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. Qureshi, R., Chen, X., Goerg, C., et al.[2022]

In a study reviewing 1289 charts of older adults with cardiovascular diagnoses, 50% had triggers indicating potential adverse drug events (ADEs), with 232 of these triggers confirmed as ADEs, highlighting the prevalence of medication-related issues in this population.

Only nine out of 39 triggers were highly predictive of ADEs, accounting for 94.4% of the detected events, suggesting that a more streamlined trigger tool could be developed to improve the identification of ADEs in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. Singh, R., McLean-Plunckett, EA., Kee, R., et al.[2022]

The introduction of 'stimulation maps' allows for a more effective visualization and analysis of data related to deep brain stimulation (DBS) for essential tremor, helping to identify the optimal lead position in the brain.

In a retrospective study of five patients, the stimulation maps indicated that the best improvement in symptoms often occurs in the posterior subthalamic area, demonstrating the technique's potential to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation maps: visualization of results of quantitative intraoperative testing for deep brain stimulation surgery. Shah, A., Vogel, D., Alonso, F., et al.[2021]

The abstract discusses the importance of rating scales like the Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr staging, and Schwab and England rating for assessing the severity of Parkinson's disease and the effectiveness of treatments.

Despite their widespread use, these rating scales have significant limitations that researchers must consider when evaluating motor symptoms and daily functioning in Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Parkinson disease manifestations. Perlmutter, JS.[2022]

Postmarketing safety evaluations of antidepressant drugs can benefit from data collected through systems like the FDA Adverse Event Reporting System and electronic medical records, which provide more extensive information than premarketing trials.

The study assesses the strengths and limitations of these data sources for pharmacovigilance, highlighting the need for consistent results and integration of evidence to improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Duan, R., Zhang, X., Du, J., et al.[2021]

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