Self-guided Treatment for Depression

NCT06028984 | Active Not Recruiting DMC FDA Device

• 1 other identifier: BH-SP-01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; depression; digital therapeutic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)

  5 weeks post-randomization, 1-month followup

• 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

Study Arms (2)

Intervention app

EXPERIMENTAL

Digitally-delivered self-guided intervention for depression accessed via mobile app

Device: Intervention app

Control app

ACTIVE COMPARATOR

An app based control condition

Other: Control app

Interventions

Intervention app DEVICE

An app-based intervention for depression

Intervention app

Control app OTHER

An app with non-therapeutic content

Control app

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Big Health Inc.: lead
• Duke University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Big Health, Inc.

San Francisco, California, 94108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 8, 2023
• Study Start: October 12, 2023
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)