Self-guided Treatment for Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06028984
• Other study ID #: BH-SP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Big Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Intervention app
An app-based intervention for depression

Other:
• Control app
An app with non-therapeutic content

Locations

Country	Name	City	State
United States	Big Health, Inc.	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Big Health Inc.	Duke University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Remission based on the Patient Health Questionnaire (PHQ-8)	PHQ-8 less than 5	5 weeks post-randomization, 1-month followup
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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