DepWatch for Depression

(DepWatch Trial)

Overseen By Parit Patel

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Must be taking: Antidepressants

Disqualifiers: Psychotic disorder, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool called DepWatch to determine if it can help doctors treat depression more effectively. DepWatch uses smartphones and wristbands to gather data on depression symptoms, aiding in predicting treatment effectiveness over time. The goal is to assess whether DepWatch can enhance the effectiveness of depression treatments. Individuals who have recently started or changed medication for moderate depression might be suitable for this trial. As an unphased trial, participants contribute to innovative research that may improve future depression treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants can be starting a new depression medication or increasing the dose of an existing one, suggesting you may continue your current treatment.

What prior data suggests that the DepWatch system is safe for use in depression treatment?

Research shows that DepWatch, a digital tool for tracking depression symptoms, is generally easy to use and doesn't cause problems. In studies of similar mobile health tools, participants reported no major issues. This suggests that using a smartphone app and wristband to collect data is usually safe and comfortable.

Since this trial uses the DepWatch app to assist doctors in deciding on treatments, it's important to note that the app is not a medicine or medical procedure. It primarily gathers information to help adjust treatments. As a digital tool, the focus is on ease of use and effectiveness, rather than on safety concerns associated with medications.

Prospective participants can feel confident that the technology is non-invasive and has been used successfully in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DepWatch for depression because it offers a novel approach to monitoring and managing the condition. Unlike traditional treatments like medication or therapy, DepWatch leverages mHealth technology to provide real-time depression and behavioral assessments. This innovative tool allows clinicians to receive and review weekly reports via a secure portal, potentially leading to more personalized and timely interventions. By integrating digital health into mental health care, DepWatch could enhance the understanding and management of depression, paving the way for more adaptive and responsive treatment strategies.

What evidence suggests that the DepWatch system is effective for improving depression treatment outcomes?

Research shows that digital tools like DepWatch can greatly aid in managing depression. In this trial, the mHealth tool 'DepWatch' will generate weekly depression and behavioral assessment reports for participants in the experimental arm, which study clinicians will review. Studies have found that mobile health platforms can predict depression symptoms with an accuracy of 79% to 91%. This suggests that DepWatch can offer timely and accurate checks of depression symptoms. By gathering information from smartphones and wristbands, DepWatch helps doctors make better treatment choices. The aim is to enhance depression treatment by providing doctors with more precise and current information about patients' mental health. ^{1 3 5 6 7}

Who Is on the Research Team?

Jayesh Kamath, MD PhD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

This trial is for adults 18 years or older with moderate depression, starting new medication or increasing the dose of their current one. Participants must score ≥11 on a specific depression questionnaire (QIDS).

Inclusion Criteria

I have moderate depression based on a specific questionnaire score.

I am starting or increasing medication for my depression.

Exclusion Criteria

Currently active substance use disorder (within 1 month of enrollment) dominating clinical scenario

I have been diagnosed with a psychotic disorder like schizophrenia.

Other clinically significant medical or psychiatric conditions that may adversely affect participants' study participation and/or affect their adherence to study protocol (as determined by study clinician) e.g., significant cognitive deficits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the DepWatch app and wear a Fitbit to collect sensory data and complete brief questionnaires. Clinicians receive weekly reports for decision making.

12 months

Weekly assessments (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• DepWatch

Trial Overview The study tests 'DepWatch', an mHealth tool that tracks and predicts depression symptoms using data from smartphones and wristbands to help doctors make better treatment decisions.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

For this group of participants: The study clinicians will receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch' via a secure clinician portal

Group II: Control Experimental Treatment 1 Intervention

For this group of participants: The study clinicians will NOT receive the weekly depression and behavioral assessment reports generated by the mHealth tool 'DepWatch'

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The mind.me app, designed for ecological momentary assessment of depressive symptoms, showed a high predictive accuracy of 0.91 in detecting clinically significant depression among 200 adults, indicating its effectiveness as a monitoring tool.

With a sensitivity of 0.98 and specificity of 0.93, the app not only accurately identifies depressive symptoms but is also rated highly by users for its usability and informative nature regarding their mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of depressive symptoms using the mind.me application: Convergence with the Patient Health Questionnaire-9 (PHQ-9). McIntyre, RS., Lee, Y., Rong, C., et al.[2021]

An updated meta-analysis of twelve randomized controlled trials involving 2901 participants confirmed that the digital intervention deprexis significantly reduces depressive symptoms, with an effect size of 0.51, indicating a clinically relevant improvement over 8-12 weeks.

The effectiveness of deprexis was consistent regardless of factors like clinician guidance or initial symptom severity, suggesting it can be a flexible and effective option for treating depression alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a tailored, integrative Internet intervention (deprexis) for depression: Updated meta-analysis. Twomey, C., O'Reilly, G., Bültmann, O., et al.[2023]

The pilot study of the CBASPath app, used as a blended therapy tool alongside traditional Cognitive Behavioral Analysis System of Psychotherapy (CBASP), showed that 93% of participants engaged with the app, indicating its feasibility in routine outpatient care for persistent depressive disorder.

Participants reported high satisfaction and usability with CBASPath, suggesting that digital tools can enhance therapy engagement and potentially improve treatment outcomes, although a randomized controlled trial is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study. Netter, AL., Beintner, I., Brakemeier, EL.[2022]

The ePST™ program, a stand-alone multimedia interactive treatment for depression, was well-received by participants, who found it highly usable, acceptable, and credible, with a therapeutic alliance comparable to live therapy.

Among the 29 participants, those who completed at least 4 sessions showed significant improvement in depressive symptoms over the 10-week study, suggesting that ePST™ may be an effective treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. Berman, MI., Buckey, JC., Hull, JG., et al.[2021]

A study involving 1013 participants showed that the web-based cognitive behavioral intervention 'deprexis' led to a significant decrease in outpatient treatment costs for psychotherapy over 12 weeks, compared to usual care.

While overall direct health care costs decreased for both groups, the intervention group experienced a 16.8% reduction in psychotherapeutic treatment costs, whereas the control group saw a 14.7% increase, highlighting the economic benefits of web-based mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study. Gräfe, V., Berger, T., Hautzinger, M., et al.[2020]

The Web-based program Deprexis significantly reduced depression severity and improved social functioning in a randomized controlled trial with 396 adults, showing a moderate effect size (Cohen's d = 0.64) after 9 weeks of treatment.

Participants who used Deprexis were much more likely to experience significant reductions in depression symptoms and recovery compared to those who did not, indicating its potential as an effective treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. Meyer, B., Berger, T., Caspar, F., et al.[2022]

The EVIDENT study, a large randomized trial, evaluated the efficacy of the self-management intervention deprexis®, which is based on cognitive behavioral therapy techniques delivered through a computer program, addressing the treatment gap for those with depressive disorders.

While previous studies have shown the effectiveness of such interventions, this study raises important questions about their efficacy in severe cases of depression and their practical use among individuals who may not be comfortable with technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-management interventions in the treatment of depressive disorders: ready for clinical practice?] Klein, JP., Berger, T., Hautzinger, M., et al.[2019]

The study aims to evaluate the effectiveness of the web-based Deprexis program, designed based on cognitive-behavioral therapy principles, for treating depression in 128 Brazilian participants with significant depressive symptoms.

If effective, Deprexis could provide a more accessible and cost-effective treatment option for depression in Brazil, especially for those unable to access traditional psychological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: a study protocol. Lopes, RT., Meyer, B., Berger, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7288984/

Grant Report on SCH: Personalized Depression Treatment ... This project will advance personalized depression treatment by developing a system, DepWatch, that leverages mobile health technologies and machine learning ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06292221/personalized-depression-treatment-supported-by-mobile-sensor-analytics?page=7&id=164&slug=depression

Personalized Depression Treatment Supported by Mobile ... This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools ...

3. jmir.org jmir.org/2022/2/e27388/

Characteristics of Mobile Health Platforms for Depression ... The objective of this review is to characterize the current state of mHealth platforms designed for anxiety or depression that are available for research, ...

4. researchgate.net researchgate.net/figure/DepWatch-high-level-approach-The-ground-truth-includes-self-reported-QIDS-Quick_fig1_342152230

DepWatch: high-level approach. The ground truth includes ... Most platforms developed for research purposes were designed for depression (116/169, 68.6%), whereas the app store search reported a higher number of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000663

Links between self-monitoring data collected through ... Based on MS data, a predictive accuracy for depression from 79 % to 91 % has been achieved [26]. One study in particular showed that in adolescents, ...

6. iproc.org iproc.org/2022/1/e39371/PDF

The Prediction of Suicidal Ideation as a Function of Daily ... Methods: This study will use data from the DepWatch study, an mHealth study that uses the DepWatch app developed by our research group.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8857696/

Characteristics of Mobile Health Platforms for Depression ... The objective of this review is to characterize the current state of mHealth platforms designed for anxiety or depression that are available for research, ...