eHealth Self-Monitoring for Depression

Overseen By Vanessa Panaite, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Psychotic, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital self-monitoring program (eHealth Intervention) to increase Veterans' engagement in mental health care, particularly for depression. The program uses online tools and text messages to help Veterans recognize symptoms and motivate treatment initiation. It targets Veterans referred for mental health services for depression who have not fully engaged. Veterans recently referred to VA mental health clinics for depression treatment might find this program suitable. As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative digital tools that could enhance their mental health care experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this eHealth intervention is safe for self-monitoring?

Research has shown that online tools for managing depression are generally safe and well-liked. In one study, 81% of users felt more involved and in control of their treatment, indicating positive views of these online services. Another study found that these digital tools were widely accepted and effectively helped reduce depression symptoms.

While no major safety issues have been reported, it's important to remember that these tools are relatively new. They primarily help individuals monitor their mental health independently. Although different from traditional treatments, they are designed to be easy to use and supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eHealth self-monitoring intervention for depression because it offers a fresh approach compared to traditional treatments like medication and in-person therapy. Unlike standard options, this intervention is delivered online and through mobile texts, making it more accessible and convenient for users. It is designed to increase self-awareness, provide support, and motivate individuals to seek further treatment, which could lead to better engagement and outcomes. This user-driven program specifically targets Veterans, a group that may benefit from its flexibility and tailored support.

What evidence suggests that this eHealth intervention is effective for depression?

Studies have shown that online health tools can help reduce symptoms of depression. For example, one study found small but meaningful improvements in depression symptoms when people used these tools. Another study showed that participants felt more involved and in control of their treatment when they tracked their progress digitally. Additionally, 81% of patients using these services reported a positive experience. This trial will evaluate a self-monitoring intervention, an online health tool, to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. These findings suggest that online health tools may effectively help people manage and reduce depression symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Vanessa Panaite, PhD

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Are You a Good Fit for This Trial?

This trial is for Veterans referred to VA mental health clinics for depression treatment. It's open to all ages and genders, but not for those with bipolar or psychotic disorders, substance abuse issues, severe cognitive impairment, unstable life situations, or other severe medical conditions that could affect the study.

Inclusion Criteria

I was recently referred to a VA clinic for depression therapy.

My age does not limit my participation.

I am eligible regardless of my gender or minority status.

Exclusion Criteria

Potentially temporary states/situations that may significantly impair mood or capability to engage in treatment: unstable environment that is not in one's control (e.g., homeless, temporary group home, extensive care taking duties)

Alcohol Use disorder or Substance Use disorder to prevent confounding effects on mood and treatment adherence

I do not have bipolar or current psychotic disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Initiation

Participants begin the self-monitoring eHealth intervention after referral to mental health services

Up to 30 weeks

Online and mobile text interactions

Treatment

Participants engage in mental health treatment with support from the self-monitoring program

Up to 30 weeks

Follow-up

Participants are monitored for treatment adherence and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eHealth Intervention

Trial Overview

The study aims to develop an eHealth intervention focused on self-monitoring to improve engagement in mental health care among Veterans with depression. Researchers will use VHA data to identify factors linked to poor treatment adherence and test strategies for better engagement.

How Is the Trial Designed?

Group I: Self-monitoring Experimental Treatment 1 Intervention

This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A free smartphone app for depression screening was downloaded by 8,241 participants from 66 countries, demonstrating its global reach and feasibility as a self-help intervention.

The app identified a high prevalence of depression risk among users, with 82.5% scoring above the PHQ-9 cut-off of 11, indicating its potential effectiveness in screening and monitoring mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression screening via a smartphone app: cross-country user characteristics and feasibility. BinDhim, NF., Shaman, AM., Trevena, L., et al.[2022]

The 'Improvehealth.eu' eHealth service was successfully implemented in a pilot study with 46 patients, showing a significant improvement in medication adherence for those using the intervention (odds ratio = 10.0, P = .03).

Patients using the eHealth service reported feeling more engaged and in control of their treatment, with 81% expressing positive perceptions, suggesting the intervention has potential to enhance treatment outcomes for depressive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. Meglic, M., Furlan, M., Kuzmanic, M., et al.[2021]

The study found that stroke patients with depressive symptoms were able to engage with an automated interactive voice response (IVR) system, completing 74% of weekly assessments, indicating good feasibility for this monitoring approach.

The IVR system not only supported self-management of depression but also facilitated communication with caregivers and primary care providers, with notifications sent for critical issues like suicidal ideation and medication non-adherence, highlighting its potential for improving post-stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-An Innovative Approach to Post-Stroke Depression Self-Management Support. Skolarus, LE., Piette, JD., Pfeiffer, PN., et al.[2018]

The second version of the Help for Depression (HDep) web-based intervention showed moderate levels of satisfaction and acceptability among users, with 98.9% of participants reporting high levels of depressive symptoms, indicating a need for effective online support in low- and middle-income countries.

Factors such as gender, age, employment status, and previous therapy experiences influenced user satisfaction and acceptability, suggesting that tailoring web-based interventions to specific user demographics could enhance their effectiveness and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction and Acceptability Ratings of a Web-Based Self-help Intervention for Depression: Retrospective Cross-sectional Study From a Resource-Limited Country. Lara, MA., Patiño, P., Tiburcio, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8842796/

Effectiveness of eHealth-Based Psychological ...

All participants showed improvements in depressive symptomatology assessed by the PHQ-9 at post-treatment, but no statistically significant differences were ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9555335/

Trends in Effectiveness of Organizational eHealth ...

eHealth interventions showed small positive effects for anxiety (Hedges g=0.26, 95% CI 0.13-0.39; P<.001), depression (Hedges g=0.26, 95% CI 0.19-0.34; P<.001), ...

3.

mental.jmir.org

mental.jmir.org/2022/12/e38049

The Effectiveness of Internet-Guided Self-help Interventions to ...

Our findings suggested that IGSH PA interventions are feasible and have the potential to reduce depressive symptoms in people with depression.

4.

withpower.com

withpower.com/trial/phase-depression-8-2023-87879

eHealth Self-Monitoring for Depression · Info for Participants

Patients using the eHealth service reported feeling more engaged and in control of their treatment, with 81% expressing positive perceptions, suggesting the ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2588914122000156

Preliminary effects of a digital mental health intervention for ...

This paper compares a need-driven digital mental healthcare intervention (DMHI) for patients diagnosed with depression or anxiety disorders with traditional ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10954845/

Efficacy of eHealth interventions to reduce depression ...

The findings showed that eHealth treatment services, supported and guided throughout the intervention had high acceptance and efficacy in the reduction of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10568392/

Efficacy, Safety, and Evaluation Criteria of mHealth ...

The primary outcome was the reduction of depressive symptoms, and secondary outcomes included undesirable effects of the mHealth intervention and the criteria ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032725005373

Exploring digital health tools for depression management ...

Although the decrease in depressive symptoms was small, the effect of digital intervention was maintained at 6 and 12 months, indicating that it ...

9.

nature.com

nature.com/articles/s41746-025-01888-5

A scalable mental health intervention for depressive ...

The real-world studies showed that the e-mental health intervention, on average, reduced users' depressive symptoms by 35% and enhanced well- ...