Rise Study for Depression

Study Overview
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Brief Summary
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This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Digital CBT
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital CBT<br>digitally-delivered CBT for depression accessed via mobile app | Device: Digital CBT<br>* An app-based intervention based on principles from cognitive behavioral therapy for depression.<br>|
| Other: Waitlist<br>Participants will wait for 5 weeks prior to receiving the intervention | Other: Waitlist<br>* Participants will wait for 5 weeks prior to receiving the intervention<br>|

What is the study measuring?
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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 | 
| Environmental Reward Observation Scale (EROS) | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities | 5 weeks post-randomization | 

Secondary 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 | 10 weeks post-randomization | 
| Montgomery-Åsberg Depression Rating Scale (MADRS) | A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity | 5 and 10 weeks post-randomization | 
| World Health Organization 5-item Wellbeing Index (WHO-5) | Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing | Weeks 5 and 10 post-randomization | 
| Environmental Reward Observation Scale (EROS) | A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities | 10 weeks post-randomization |