Clinical trial NCT06028984: Self-guided Treatment for Depression
Official title: Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
depression
digital therapeutic
Lead sponsor: Big Health Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: National Institute of Mental Health (NIMH)
First posted: 2023-09-08
Enrollment: 248
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)
* 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 5 weeks post-randomization
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 5 weeks post-randomization
Secondary outcomes:
measure: Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
timeFrame: 5 weeks post-randomization, 1-month followup
measure: Response based on the Patient Health Questionnaire (PHQ-8)
timeFrame: 5 weeks post-randomization, 1-month followup
measure: Remission based on the Patient Health Questionnaire (PHQ-8)
timeFrame: 5 weeks post-randomization, 1-month followup
measure: Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: 5 weeks post-randomization, 1-month followup
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: 5-weeks post-randomization, 1-month followup
measure: Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
timeFrame: 5 weeks post-randomization, 1-month followup
measure: Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup
timeFrame: 1-, 3- and 6-month followup
measure: Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup
timeFrame: 1 month follow up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Big Health, Inc.
state: California
Study officials:
References: