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

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Depression is the most prevalent mental health condition among VHA patients and is strongly associated with poor functioning, negative health outcomes, and suicide. Despite effective and available treatments, engagement in care is poor. This study will analyze VHA electronic medical record data, to identify patient characteristics associated with poor treatment engagement. The study will then develop and formatively evaluate an eHealth intervention to improve and sustain engagement in mental health care through self-monitoring. This is an important step in engaging Veterans who, in part, based on their military training, may have difficulty identifying or accepting depressed affect and the benefits of treatment. The information obtained will inform clinical strategies and operations policy to improve quality, coordination, and efficiency of mental health services.

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.

Is eHealth self-monitoring for depression safe for humans?

The research does not provide specific safety data for eHealth self-monitoring systems, but it discusses usability, adherence, and acceptability, which are important for ensuring that users can safely and effectively engage with the system. ^{1 2 3 4 5}

How is eHealth self-monitoring for depression different from other treatments?

eHealth self-monitoring for depression is unique because it uses electronic systems to help patients track their symptoms and receive personalized feedback, which can increase emotional self-awareness and support self-management. This approach is different from traditional treatments as it offers daily support and can be easily accessed through mobile phones, making it a low-cost and flexible option for managing depression. ^{1 6 7 8 9}

What data supports the effectiveness of the eHealth Intervention treatment for depression?

Research shows that eHealth-based cognitive behavioral therapy (a type of talk therapy) can effectively reduce depression and anxiety symptoms. Additionally, eHealth services that support collaborative care and self-monitoring have been found to improve treatment outcomes and patient engagement in managing depression. ^{1 9 10 11 12}

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

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]

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]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Usability, Acceptability, and Adherence to an Electronic Self-Monitoring System in Patients With Major Depression Discharged From Inpatient Wards. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Innovative ICT solutions to improve treatment outcomes for depression: the ICT4Depression project. [2022]

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

Effectiveness of eHealth-based cognitive behavioural therapy on depression: A systematic review and meta-analysis. [2022]

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

Interactive Voice Response-An Innovative Approach to Post-Stroke Depression Self-Management Support. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

Comprehensive Online Self-Monitoring to Support Clinicians Manage Risk of Suicide in Youth Depression. [2022]

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

Case management and adherence to an online disease management system. [2006]

8. England pubmed.ncbi.nlm.nih.gov

GPs' attitudes towards digital technologies for depression: an online survey in primary care. [2020]

9. Canada 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Depression screening via a smartphone app: cross-country user characteristics and feasibility. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Self-monitoring using mobile phones in the early stages of adolescent depression: randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: a protocol of a pragmatic randomized controlled trial (ZELF-i). [2019]