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Self-guided Treatment for Depression | Clinical Trials | Clareo Health

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Self-guided Treatment for Depression

Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial

NCT06028984•Big Health Inc.

Summary

This study will examine the efficacy and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.

Detailed Description

This study aims to examine the efficacy of a self-guided digital therapeutic app for depression compared to a control app in individuals aged 13 and older with a diagnosis of Major Depressive Disorder. The primary outcomes are patient- and clinician-reported depression symptom severity after 5 weeks.

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Positive self report screen for depression
•Participant is at least 13 years of age
•Willing and able to provide informed consent; if under 18 years of age, willing and able to provide assent, and has a legal guardian willing and able to provide consent
•Primary diagnosis of Major Depressive Disorder (MDD)
•Under the care of a United States (U.S.)-based licensed healthcare provider and willing and able to provide contact information for the provider and sign a HIPAA release that allows investigator to contact provider
•Fluent and literate in English
•Has access to a compatible device and operating system (i.e., capable of installing the app from the Google Play or Apple App Store) and regular internet access
•Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the primary study period

Exclusion Criteria

•Has changed or initiated psychotherapy with a mental health professional within 30 days prior to eligibility screening
•Has received certain types of psychotherapy within the last 6 months
•Has changed prescribed psychotropic medication (initiation or change in dose) within the past 30 days
•Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during study intervention period
•Suicidal behavior within the past year
•Active suicide ideation with intent within the past 3 months
•Previously participated in user testing or a clinical study at Limbix Health Inc. or Big Health Inc. (such as the STAND study or Rise study), or have used a Limbix app
•Participated in any other clinical research involving an intervention or treatment within the past 60 days
•Plans to participate in any other clinical research involving an intervention or treatment during the study intervention period
•Living in the same household as another participant in the study (e.g., a sibling)
+5 more criteria

Locations (1)

Big Health, Inc.

San Francisco, California, United States

Key Dates

Start Date

October 12, 2023

Primary Completion Date

March 1, 2025

Completion Date

September 1, 2025

Last Updated

April 5, 2024

Enrollment

248

ESTIMATED participants

Conditions

Major Depressive Disorder

Interventions

Intervention app

DEVICE

Control app

OTHER

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Self-guided Treatment for Depression

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)