Major Depressive Disorder
Conditions
Brief summary
This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.
Detailed description
This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.
Interventions
DEVICEDigital CBT
An app-based intervention based on principles from cognitive behavioral therapy for depression.
OTHERWaitlist
Participants will wait for 5 weeks prior to receiving the intervention
Sponsors
Big Health Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥22 years old * Score ≥10 and \<20 on the 8-item Patient Health Questionnaire (PHQ-8) * Diagnosis of Major Depression * Current resident of the USA * Oral and written fluency in English * Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher) * Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Exclusion criteria
* Must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months * If on psychotropic medication, this must be stable for at least 60 days * Past or present psychosis, schizophrenia, or bipolar disorder * Moderate or greater suicide risk * Treatment-resistant depression * Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation * Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures * Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities * Other
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 |
| Environmental Reward Observation Scale (EROS) | 5 weeks post-randomization | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-8) | 10 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 and 10 weeks post-randomization | A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity |
| World Health Organization 5-item Wellbeing Index (WHO-5) | Weeks 5 and 10 post-randomization | Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing |
| Environmental Reward Observation Scale (EROS) | 10 weeks post-randomization | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities |
Countries
United States
Outcome results
None listed