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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mobile phone app can effectively help African Americans manage depression. Participants will attend weekly online classes through the app and complete surveys to track their progress. The trial aims to determine if this digital treatment, called OHDC-DC, can reduce symptoms of depression. It suits African Americans who have been dealing with depression, have a mobile phone, and are not currently in therapy or experiencing severe depression symptoms. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new methods of managing depression.

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 prior data suggests that this mobile app is safe for delivering depression treatment?

Research findings suggest that participants have positively received the Oh Happy Day Class - Digital Connections (OHDC-DC) treatment in previous studies. One study showed that 73% of participants completed the full program, indicating it is generally well-tolerated. However, specific safety information for the OHDC-DC mobile app itself is not available. As the trial is in the "Not Applicable" phase, the treatment is still being tested for safety and effectiveness, and no confirmed safety profile exists yet. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for depression, which typically involve medication or therapy, the OHDC-DC offers a digital, app-based approach. Researchers are excited about this treatment because it leverages technology to provide support and resources directly to users' smartphones, making it more accessible and convenient. Additionally, the app can potentially offer real-time feedback and personalized interventions, which might enhance user engagement and improve outcomes. This innovative approach could address barriers such as stigma and access to care, making support available anytime and anywhere.

What evidence suggests that this mobile app is effective for depression?

Research shows that the OHDC-DC treatment, which participants in this trial will receive, is designed to ease depression symptoms using culturally relevant strategies. Earlier small studies found that the app can help keep people engaged and satisfied with their treatment, which is important for managing depression. The app includes 13 modules that help users understand depression better and encourage healthy coping strategies. Early results suggest that digital tools like this can support positive lifestyle changes, potentially reducing depression symptoms. Although solid data on its effectiveness for large groups is not yet available, this approach focuses on known factors that can improve mental health. ^{1 3 6 7 8}

Who Is on the Research Team?

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 am currently having thoughts about harming myself.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06206226?aggFilters=status%3Anot%2Cphase%3A

The Oh Happy Day Class - Digital Connections (OHDC-DC ... OHDC originally comprised of 13 treatment modules focused on culturally relevant strategies to increase knowledge of depression and healthy coping behaviors ...

2. ctv.veeva.com ctv.veeva.com/study/the-oh-happy-day-class-digital-connections-ohdc-dc-a-pilot-study

The Oh Happy Day Class - Digital Connections (OHDC-DC) The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4314356/

A Culturally Adapted Depression Intervention for African ... This paper describes development of the OHDC and two pilot studies conducted to test feasibility (increase retention in treatment) and acceptability (increase ...

4. trial.medpath.com trial.medpath.com/clinical-trial/f4240ac7c7e54aeb/nct07022184-personalized-lifestyle-intervention-depression-general-practice

Lifestyle Intervention for Symptoms of Depression wIth App Support ... The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and ...

5. withpower.com withpower.com/trial/phase-depression-1-2024-15deb

Mobile App for Depression (OHDC-DC 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.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06206226/the-oh-happy-day-class-digital-connections-ohdc-dc-a-pilot-study

The Oh Happy Day Class - Digital Connections (OHDC-DC) The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25420141/

A Culturally Adapted Depression Intervention for African ... Results for Pilot I showed 73% of participants completed the full OHDC, a statistically significant decline in depression symptoms from pre- to ...

8. wmjonline.org wmjonline.org/wp-content/uploads/2021/120/4/273-1.pdf

A Culturally Adapted Depression Intervention for African ... Because of the high rates of disability associated with depression among African Americans, we predicted the OHDC would increase self-reports of improved mental ...