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Active Intervention for Depression

N/A

Waitlist Available

Led By Aarthi Padmanabhan, PhD

Research Sponsored by Limbix Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention (5 week timepoint)

Awards & highlights

Study Summary

This trial is testing whether an app can help treat symptoms of depression in adolescents. Eligible participants will be randomly assigned to either use the app or continue their usual care, and both groups will use the app for 5 weeks.

Eligible Conditions

Depression
Major Depressive Episode

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (5 week timepoint)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (5 week timepoint)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (5 week timepoint) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Depressive symptom severity at post-intervention

Secondary outcome measures

Clinically-meaningful reduction in severity at post-intervention

Intervention response at post-intervention

Remission at post-intervention

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active InterventionExperimental Treatment1 Intervention

The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.

Group II: Usual CareActive Control1 Intervention

UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Intervention

2008

N/A

~4470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Limbix Health, Inc.Lead Sponsor

7 Previous Clinical Trials

505 Total Patients Enrolled

5 Trials studying Depression

425 Patients Enrolled for Depression

Aarthi Padmanabhan, PhDPrincipal InvestigatorLimbix Health, Inc.

1 Previous Clinical Trials

2 Total Patients Enrolled

1 Trials studying Depression

2 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.

Are there any openings for participation in the current clinical trial?

"Affirmative. According to the information present on clinicaltrials.gov, this research is actively recruiting individuals for participation. It was initially posted on July 28th 2022 and its most recent update occurred in October 5th 2022."

Answered by AI

Is this clinical trial open to participants above the age of thirty?

"This particular medical trial is searching for people aged between 13 and 21. Currently, there are 192 trials recruiting patients of the former age group and 965 studies targeting individuals in the latter cohort."

Answered by AI

How many participants are receiving care in this research endeavor?

"Correct. According to the clinicaltrials.gov listing, this trial is actively seeking participants and was initially posted on July 28th 2022 with its most recent edit being recorded on October 5th 2022. A total of 220 patients distributed across 1 site must be enrolled for the experiment to proceed."

Answered by AI

What are the qualifications for participants in this trial?

"To participate in this trial, adolescents between the ages of 13 and 21 who are suffering from melancholia can apply. The clinical team is currently seeking 220 individuals for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Self-guided Treatment for Adolescents Navigating Depression

2022. "Self-guided Treatment for Adolescents Navigating Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462652.