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Digital App Therapy for Depression

N/A
Waitlist Available
Research Sponsored by Big Health Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is at least 13 years of age
Primary diagnosis of Major Depressive Disorder (MDD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3- and 6-month followup
Awards & highlights

Study Summary

This trial studies a digital app to help treat depression in teens & adults, to see if it's safe & useful.

Who is the study for?
This trial is for adolescents and adults with Major Depressive Disorder who are fluent in English, have access to a compatible device with internet, and are under the care of a U.S.-based healthcare provider. It's not for those with bipolar disorder, severe substance use disorder in the past year, recent changes in psychotropic meds or psychotherapy, or suicidal behavior recently.Check my eligibility
What is being tested?
The study tests a self-guided digital therapeutic app designed to help manage depression against a control app. Participants will use their own devices to interact with the apps while researchers monitor safety and effectiveness.See study design
What are the potential side effects?
Since this trial involves digital apps rather than medication, traditional side effects like you might see with drugs aren't expected. However, users may experience discomfort or emotional distress related to engaging with mental health content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 13 years old or older.
Select...
I have been diagnosed with Major Depressive Disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3- and 6-month followup
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 3- and 6-month followup for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Åsberg Depression Rating Scale (MADRS)
Patient Health Questionnaire (PHQ-8)
Secondary outcome measures
Clinical Global Impression - Severity (CGI-S)
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention appExperimental Treatment1 Intervention
Digitally-delivered self-guided intervention for depression accessed via mobile app
Group II: Control appActive Control1 Intervention
An app based control condition

Find a Location

Who is running the clinical trial?

Big Health Inc.Lead Sponsor
11 Previous Clinical Trials
139,083 Total Patients Enrolled
Duke UniversityOTHER
2,360 Previous Clinical Trials
3,420,082 Total Patients Enrolled
74 Trials studying Depression
34,108 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,027 Total Patients Enrolled
666 Trials studying Depression
251,336 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research team require any additional volunteers?

"It appears that this clinical trial is not currently enrolling patients. According to the information on clinicaltrials.gov, it was posted on September 1st 2023 and last edited by August 29th 2023. However, there are many other studies actively recruiting at present with a total of 1384 sites available for potential applicants."

Answered by AI

What potential outcomes is this medical experiment designed to ascertain?

"Per the reports issued by Big Health Inc., who are sponsoring this experiment, a 5 week post-randomization period will be used to measure Montgomery-Åsberg Depression Rating Scale (MADRS) as its primary outcome. Supplementary outcomes being examined include Response based on Patient Health Questionnaire (PHQ-8), which is determined when there is 50% or more diminishment of PHQ-8 score from initial point; Remission assessed using Patient Health Questionnaire (PHQ-8); and Global improvement gauged using clinician rated Clinical Global Impression Scale - Improvement (CGI–I). This last metric uses single"

Answered by AI

Who else is applying?

What site did they apply to?
Big Health, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

What questions have other patients asked about this trial?

Duration of visits, compensation rates, which vitals (if any) need to be collected for this study?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have tried 4 different anti-depressants with little to no effect.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Self-guided Treatment for Depression
2023. "Self-guided Treatment for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028984.
~155 spots leftby Mar 2025
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