Self-guided Treatment for Depression

Study 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.

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

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Device: Intervention app
* Other: Control app


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Major Depressive Disorder, depression, digital therapeutic