Rise Study for Depression

Big Health

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Other: Waitlist; Device: Digital CBT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06003361

BH-D-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Digital CBT

Experimental group

Description:

digitally-delivered CBT for depression accessed via mobile app

Treatment:

Device: Digital CBT

Waitlist

Other group

Description:

Participants will wait for 5 weeks prior to receiving the intervention

Treatment:

Other: Waitlist