Self-guided Treatment for Depression

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Intervention app; Other: Control app

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.

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • Big Health, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)
• Has a diagnosis of MDD with psychotic features or comorbid Psychotic Disorder
• Has a concurrent diagnosis of (or has been treated for) bipolar disorder I and II or severe substance use disorder within the past year
• Has treatment resistant depression
• Is employed by Big Health Inc., or is a collaborator, associate, or relation of Big Health Inc. staff
• Any condition, comorbidity, or event (other than the above) that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the intervention, or will prevent investigators from being able to ensure safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention app; Digitally-delivered self-guided intervention for depression accessed via mobile app	Device: Intervention app; An app-based intervention for depression
Active Comparator: Control app; An app based control condition	Other: Control app; An app with non-therapeutic content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-8)	Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity	5 weeks post-randomization
Montgomery-Åsberg Depression Rating Scale (MADRS)	Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity	5 weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)	5 point or greater reduction in PHQ-8 score from baseline	5 weeks post-randomization, 1-month followup
Response based on the Patient Health Questionnaire (PHQ-8)	50% or greater reduction in PHQ-8 score from baseline	5 weeks post-randomization, 1-month followup
Remission based on the Patient Health Questionnaire (PHQ-8)	PHQ-8 less than 5	5 weeks post-randomization, 1-month followup
Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)	A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning	5 weeks post-randomization, 1-month followup
Clinical Global Impression - Severity (CGI-S)	A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms	5-weeks post-randomization, 1-month followup
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)	10 point or greater reduction in MADRS score from baseline	5 weeks post-randomization, 1-month followup
Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup	Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity	1-, 3- and 6-month followup
Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup	Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity	1 month follow up

Collaborators and Investigators

• Sponsor: Big Health Inc.
• Collaborators: National Institute of Mental Health (NIMH); Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: depression; MDD; Major Depressive Disorder; digital therapeutic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: BH-SP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes