Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, MDD, depression, digital therapeutic
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.
Interventions
DEVICEIntervention app
An app-based intervention for depression
OTHERControl app
An app with non-therapeutic content
Sponsors
Duke University
National Institute of Mental Health (NIMH)
Big Health Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | 5 weeks post-randomization | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 5 weeks post-randomization | Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission based on the Patient Health Questionnaire (PHQ-8) | 5 weeks post-randomization, 1-month followup | PHQ-8 less than 5 |
| Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I) | 5 weeks post-randomization, 1-month followup | A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning |
| Clinical Global Impression - Severity (CGI-S) | 5-weeks post-randomization, 1-month followup | A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms |
| Clinically important improvement based on the Patient Health Questionnaire (PHQ-8) | 5 weeks post-randomization, 1-month followup | 5 point or greater reduction in PHQ-8 score from baseline |
| Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup | 1-, 3- and 6-month followup | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity |
| Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup | 1 month follow up | Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity |
| Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS) | 5 weeks post-randomization, 1-month followup | 10 point or greater reduction in MADRS score from baseline |
| Response based on the Patient Health Questionnaire (PHQ-8) | 5 weeks post-randomization, 1-month followup | 50% or greater reduction in PHQ-8 score from baseline |
Countries
United States
Outcome results
None listed