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

Big Health Inc.1 site in 1 country248 target enrollmentOctober 12, 2023

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Big Health Inc.
Enrollment: 248
Locations: 1
Primary Endpoint: Patient Health Questionnaire (PHQ-8)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 12, 2023

End Date

September 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Big Health Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-8)

Time Frame: 5 weeks post-randomization

Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity

Montgomery-Åsberg Depression Rating Scale (MADRS)

Time Frame: 5 weeks post-randomization

Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity

Secondary Outcomes

Response based on the Patient Health Questionnaire (PHQ-8)(5 weeks post-randomization, 1-month followup)
Remission based on the Patient Health Questionnaire (PHQ-8)(5 weeks post-randomization, 1-month followup)
Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)(5 weeks post-randomization, 1-month followup)
Clinical Global Impression - Severity (CGI-S)(5-weeks post-randomization, 1-month followup)
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)(5 weeks post-randomization, 1-month followup)
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)(5 weeks post-randomization, 1-month followup)
Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup(1-, 3- and 6-month followup)
Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup(1 month follow up)