DepWatch for Depression
(DepWatch Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UConn Health
Must be taking: Antidepressants
Disqualifiers: Psychotic disorder, Substance use, others
No Placebo Group
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.
12345How 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.
34678Eligibility 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 am 18 years old or older.
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
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 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: ControlExperimental Treatment1 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'
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Connecticut Health CenterFarmington, CT
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Who Is Running the Clinical Trial?
UConn HealthLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study. [2020]Depression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention "deprexis" in reducing disease-related costs.
[Self-management interventions in the treatment of depressive disorders: ready for clinical practice?] [2019]Only about half of those suffering from a depressive disorder seek treatment. Self-management interventions are one way to reduce this treatment gap. These interventions are mostly based on evidence-based techniques of cognitive behavioural therapy, which are taught by a computer program instead of a therapist. Numerous studies have shown the effectiveness of these interventions. However, these studies also raise a number of questions. These concern the efficacy both in the external rating and in the long-term course and the efficacy in severe depressive symptoms or in combination with antidepressant medication. Finally, the question arises as to the use of these interventions in patients in clinical practice and in people who are not particularly Internet-savvy. We addressed these questions in a large randomized study (EVIDENT study). This study investigated the efficacy of Intervention deprexis®. The results of this study are summarised in this overview and placed in the context of other interventions available in Germany.
Effectiveness of a tailored, integrative Internet intervention (deprexis) for depression: Updated meta-analysis. [2023]Digitally delivered interventions for depression vary in many aspects, including their therapeutic orientation, depth of content, interactivity, individual tailoring, inclusion of multimedia, cost, and effectiveness. However, their effectiveness is rarely examined in intervention-specific meta-analyses. An earlier meta-analysis of eight randomized controlled trials (RCT) demonstrated the effectiveness of a tailored, integrative digital intervention (deprexis), which is delivered via the Internet. This updated meta-analysis of twelve deprexis-specific RCT with a total of N = 2901 participants confirmed the effectiveness of deprexis for depression reduction at post-intervention (g = 0.51, 95% CI: 0.40-0.62, I2 = 26%). Results were analogous when study quality, screening and randomization procedure were taken into account. Clinician guidance, developer-involvement, setting (community vs. clinical), and initial symptom severity did not have statistically significant effects on the effect size, and there was no evidence of publication bias. Thus, these findings demonstrate that deprexis can facilitate clinically relevant reduction of depressive symptoms over 8-12 weeks across a broad range of initial symptom severity, and that the intervention can be combined with other forms of depression treatment. There is now a need to study the intervention's implementation in routine care settings as well as its long-term effectiveness and cost-effectiveness in diverse cultural and linguistic settings.
Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. [2021]Computer-based depression interventions lacking live therapist support have difficulty engaging users. This study evaluated the usability, acceptability, credibility, therapeutic alliance and efficacy of a stand-alone multimedia, interactive, computer-based Problem Solving Treatment program (ePST™) for depression. The program simulated live treatment from an expert PST therapist, and delivered 6 ePST™ sessions over 9weeks. Twenty-nine participants with moderate-severe symptoms received the intervention; 23 completed a minimally adequate dose of ePST™ (at least 4 sessions). Program usability, acceptability, credibility, and therapeutic alliance were assessed at treatment midpoint and endpoint. Depressive symptoms and health-related functioning were assessed at baseline, treatment midpoint (4weeks), and study endpoint (10weeks). Depression outcomes and therapeutic alliance ratings were also compared to previously published research on live PST and computer-based depression therapy. Participants rated the program as highly usable, acceptable, and credible, and reported a therapeutic alliance with the program comparable to that observed in live therapy. Depressive symptoms improved significantly over time. These findings also provide preliminary evidence that ePST™ may be effective as a depression treatment. Larger clinical trials with diverse samples are indicated.
Adding an App-Based Intervention to the Cognitive Behavioral Analysis System of Psychotherapy in Routine Outpatient Psychotherapy Treatment: Proof-of-Concept Study. [2022]The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is an empirically supported psychotherapeutic treatment developed specifically for persistent depressive disorder. However, given the high rates of nonresponse and relapse, there is a need for optimization. Studies suggest that outcomes can be improved by increasing the treatment dose via, for example, the continuous web-based application of therapy strategies between sessions. The strong emphasis in CBASP on the therapeutic relationship, combined with limited therapeutic availabilities, encourages the addition of web-based interventions to face-to-face therapy in terms of blended therapy.
Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: a study protocol. [2021]Although psychological treatments for depressive disorders are available, they are often expensive or inaccessible for many. Web-based interventions that require minimal or no contact with therapists have been shown effective. To the best of our knowledge, no study using this treatment format has been conducted in Brazil. The Deprexis program was designed using empirically established principles of cognitive-behavioral therapy to reduce depressive symptoms. The objective of this study was to evaluate the effectiveness of Deprexis in Brazil. This randomized controlled trial will include 128 Brazilians with clinically significant depression symptoms or who have been diagnosed with depressive disorder (major depressive disorder or dysthymia), recruited over the internet (Brazilian forums, social networks, or e-mail lists). Individuals with other psychiatric diagnoses that require significant attention (e.g., bipolar disorder, psychosis) will not be included in the trial. Participants will be randomly assigned to 1) treatment as usual plus immediate access to Deprexis or 2) treatment as usual plus delayed access to Deprexis (after 8 weeks). Participants will be able to obtain other treatment types in addition to the online intervention. If found effective, this web-based intervention would increase the evidence-based care options for depression treatment in Brazil. RBR-6kk3bx, UTN U1111-1212-8998.
Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. [2022]Depression is associated with immense suffering and costs, and many patients receive inadequate care, often because of the limited availability of treatment. Web-based treatments may play an increasingly important role in closing this gap between demand and supply. We developed the integrative, Web-based program Deprexis, which covers therapeutic approaches such as behavioral activation, cognitive restructuring, mindfulness/acceptance exercises, and social skills training.
Ecological momentary assessment of depressive symptoms using the mind.me application: Convergence with the Patient Health Questionnaire-9 (PHQ-9). [2021]Ecological momentary assessment (EMA) for mental disorders, using application-based (app) technology capable of passive and ambient data collection, has been insufficiently evaluated and validated with rigorous, adequately-powered, high-quality studies. Herein, we sought to validate the mind.me application for the assessment of depressive symptoms in adults. Adults (ages 18-65) who self-identified as having clinically significant depressive symptoms [i.e. Patient Health Questionnaire 9 (PHQ-9) ≥ 5] utilized the mind.me app-a mobile phone technology that collects data passively and continuously, and is capable of integrating broad multimodal data [e.g., location variance (e.g. GPS), behavioural (e.g. social network activity), and communication data (e.g. SMS texting, phone calls)]. The primary outcome was predictive accuracy (i.e. convergent validity with depressive symptom measurement, as captured by the PHQ-9). 200 subjects were enrolled in the study (mean age 46 ± 12.71). The average PHQ-9 score was 12.8 ± 6.9. The predictive accuracy of the mind.me app was 0.91 ± 0.06. The sensitivity was 0.98 and the specificity was 0.93. The mind.me app was rated by 200 users as highly usable and informative to their illness. The mind.me app exhibits robust predictive accuracy in detecting depressive symptoms in adults with clinically relevant depressive symptoms. The mind.me app more specifically demonstrates convergence with the PHQ-9.