DepWatch for Depression

(DepWatch Trial)

Overseen By Galina Prpich, MS

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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows: 1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process 2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period.

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 data supports the effectiveness of the treatment DepWatch for Depression?

Research on similar digital interventions, like deprexis, shows they can effectively reduce depression symptoms. These interventions are delivered online and have been proven to help people with depression feel better over a period of 8-12 weeks. ^{1 2 3 4 5}

How is the DepWatch treatment different from other depression treatments?

DepWatch is unique because it likely involves a digital or app-based approach, similar to other internet-based interventions like Deprexis, which use technology to deliver therapy without the need for direct therapist contact. This can make it more accessible and convenient for users, allowing them to engage with the treatment at their own pace and in their own environment. ^{3 4 6 7 8}

Research Team

Jayesh Kamath, MD PhD

Principal Investigator

UConn Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Self-management interventions in the treatment of depressive disorders: ready for clinical practice?] [2019]

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

Effectiveness of a tailored, integrative Internet intervention (deprexis) for depression: Updated meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. [2021]

5. Canada 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. [2022]

6. Brazil 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. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. [2022]

8. England 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). [2021]