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Behavioral Health App for Depression

N/A
Recruiting
Led By Eva Szigethy
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English-speaking participant
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is testing whether a digital cognitive behavioral intervention (d-CBI) enhanced with coaching can help treat moderate depression in children as part of routine pediatric care. The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions.

Who is the study for?
This trial is for young people aged 16-22 who are experiencing moderate depression, as indicated by a score of 10 or higher on the PHQ-9 scale. Participants must be English-speaking and have access to a smartphone. It's not suitable for those with extremely severe depression, recent hospitalization for dangerousness, recent suicide attempts requiring medical attention, or severe psychiatric disorders.Check my eligibility
What is being tested?
The study compares two approaches: one group uses a behavioral health app called RxWell along with their usual treatment (TAU), while the other group only receives TAU. The effectiveness of adding the digital cognitive behavioral intervention to standard care in reducing symptoms of depression will be evaluated.See study design
What are the potential side effects?
Since this trial involves a digital app and standard care practices rather than medication, traditional side effects are not expected. However, participants may experience discomfort or emotional distress when engaging with mental health content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depression severity
Secondary outcome measures
Change in anxiety severity
Change in depression severity; evidence of passive suicidal ideation
Change in general level of functioning
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: dCBI + Treatment as UsualExperimental Treatment2 Interventions
Participants randomly assigned to the intervention group (dCBI+TAU) will receive standard care and also gain access to the dCBI. The dCBI, RxWell, is a trans-Cognitive Behavioral Therapy (CBT) mobile app product addressing depression and anxiety that was developed based on standard CBT techniques.
Group II: Treatment as Usual (TAU)Experimental Treatment1 Intervention
Participants who are randomly assigned to the Treatment as Usual (TAU) group will receive standard care, which will consist of a tiered stepped care model of behavioral therapy offered by the embedded behavioral therapist at each practice as part of routine care, with the provision of augmentation of therapy (or addition of an antidepressant) at the discretion of the clinical team. Psychotropic medications at baseline and previous behavioral treatment will be recorded at baseline. Number of therapy sessions, delivery modality (face to face versus telemedicine), and addition of antidepressant or other psychotropic medication or dose change will be monitored and recorded over the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment as Usual
2016
Completed Phase 3
~2710

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Who is running the clinical trial?

University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,338,507 Total Patients Enrolled
119 Trials studying Depression
33,326 Patients Enrolled for Depression
Eva SzigethyPrincipal InvestigatorUniversity of Pittsburgh
~243 spots leftby Jul 2025
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