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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Research Team

Aaron S Heller, PhD

Principal Investigator

University of Miami

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

GPs' views on the use of depression screening and GP-targeted feedback: a qualitative study. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Views of patients diagnosed with depression and cared for by general practitioners and psychiatrists]. [2021]

3. Netherlands 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? [2015]

4. France pubmed.ncbi.nlm.nih.gov

[Improving care for depressed patients: what is added by GP's meetings?]. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Improved recognition and treatment of depression with occasional faster recovery through postgraduate training of family practitioners]. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Experience with a trigger tool for identifying adverse drug events among older adults in ambulatory primary care. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. [2022]

9. England 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. [2021]

10. United States 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. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Therapeutic maps for a sensor-based evaluation of deep brain stimulation programming. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Stimulation maps: visualization of results of quantitative intraoperative testing for deep brain stimulation surgery. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Monitoring gait at home with radio waves in Parkinson's disease: A marker of severity, progression, and medication response. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Assessment of Parkinson disease manifestations. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Clinical Assessments in Parkinson's Disease: Scales and Monitoring. [2022]