Mobile App for Depression

(OHDC-DC Trial)

Overseen By Shari Barlow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Psychotropic medications

Disqualifiers: Psychotherapy, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

8 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot join if you started psychotropic medication (medication for mental health conditions) less than three months ago.

What data supports the effectiveness of the treatment OHDC-DC for depression?

Research shows that mobile apps for depression self-management can improve patient self-management, treatment engagement, and mental health outcomes, with over half of the apps reviewed having acceptable quality. This suggests that app-based interventions, like the one involving OHDC-DC, have potential to be effective in managing depression. ^{1 2 3 4 5}

Is the mobile app for depression, also known as OHDC-DC, safe for humans?

There is no specific safety data available for the mobile app for depression or OHDC-DC in the provided research articles. ^{6 7 8 9 10}

How does the treatment OHDC-DC differ from other treatments for depression?

The treatment OHDC-DC is unique because it is delivered through a mobile app, which may include features like self-help treatments, automatic patient assessments, and just-in-time interventions, making it more accessible and potentially more engaging than traditional in-person therapies. ^{1 2 5 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression. Participants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.

Research Team

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for African Americans experiencing depression. Participants will use a mobile app to attend weekly classes and complete surveys. The study lasts four months, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am experiencing depression, as shown by my PHQ-9 score.

African-American

Own a mobile phone

Exclusion Criteria

Participants scoring 25 or higher on the PHQ-9 will be screened out

I am currently undergoing psychotherapy.

I have not started any new mental health medications in the last three months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend six 90-minute weekly cognitive behavioral psycho-education classes via a mobile app

6 weeks

6 visits (virtual)

Engagement

Participants are encouraged to stay engaged between classes by digitally connecting on the app with class content

6 weeks

Follow-up

Participants are monitored for changes in depressive symptoms and satisfaction with the intervention

4 weeks

Treatment Details

Interventions

• OHDC-DC

Trial Overview The OHDC-DC pilot study tests if a mobile phone app can effectively deliver treatment to reduce symptoms of depression through six 90-minute weekly classes.

Participant Groups

Group I: Oh Happy Day Class-Digital Connections (OHDC-DC) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

A systematic review of mobile health apps for depression found that 74% of the evaluated apps had acceptable quality, with 32% scoring 4.0 or higher on the Mobile Application Rating Scale (MARS), indicating their potential effectiveness.

These high-quality apps can enhance patient self-management and treatment engagement, suggesting they may be valuable tools for individuals with depression who face barriers to traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Commercially Available Mobile Apps for Depression Self-Management. Myers, A., Chesebrough, L., Hu, R., et al.[2022]

A study involving 235 participants showed that the app-based intervention ImproveYourMood+ significantly reduced depressive symptoms and negative automatic thoughts over a 3-week period, with effects lasting up to one month after the intervention.

The most effective features of the app included mood monitoring, content delivery, and just-in-time prompts, indicating that comprehensive, multi-modal approaches may enhance user experience and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. Everitt, N., Broadbent, J., Richardson, B., et al.[2021]

Postmarketing safety evaluations of antidepressant drugs can benefit from data collected through systems like the FDA Adverse Event Reporting System and electronic medical records, which provide more extensive information than premarketing trials.

The study assesses the strengths and limitations of these data sources for pharmacovigilance, highlighting the need for consistent results and integration of evidence to improve drug safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. Duan, R., Zhang, X., Du, J., et al.[2021]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

Over a 30-year period, 1366 reports of adverse drug reactions (ADRs) associated with antidepressants in children and adolescents were identified, highlighting a significant prevalence of neuropsychiatric issues such as sleepiness, agitation, and suicidal thoughts.

The study revealed a concerning trend of increased reporting of suicidal thinking and behavior after 2003, suggesting that black box warnings may have influenced both reporting practices and the use of antidepressants in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study. Barthez, S., Revet, A., Chouchana, L., et al.[2021]

References

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

Development of a Mobile Clinical Prediction Tool to Estimate Future Depression Severity and Guide Treatment in Primary Care: User-Centered Design. [2019]

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

Evaluating Commercially Available Mobile Apps for Depression Self-Management. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Smartphone Apps in Patients With Depressive Disorders: A Systematic Review. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Utilization of Patient-Generated Data Collected Through Mobile Devices: Insights From a Survey on Attitudes Toward Mobile Self-Monitoring and Self-Management Apps for Depression. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the features of an app-based just-in-time intervention for depression. [2021]

6. England pubmed.ncbi.nlm.nih.gov

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Monitoring for antidepressant-associated adverse events in the treatment of patients with major depressive disorder: An international consensus statement. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Apps for Depression: Are They Ready to Work? [2020]