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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
248
An app-based intervention for depression
An app with non-therapeutic content
Big Health, Inc.
San Francisco, California, United States
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time frame: 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
Time frame: 5 weeks post-randomization
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
5 point or greater reduction in PHQ-8 score from baseline
Time frame: 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
Time frame: 5 weeks post-randomization, 1-month followup
Remission based on the Patient Health Questionnaire (PHQ-8)
PHQ-8 less than 5
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 month follow up