Rise Study for Depression

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Digital CBT; Other: Waitlist

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • Big Health Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Big Health Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: BH-D-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes