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

Big Health Inc.1 site in 1 country61 target enrollmentAugust 31, 2023

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Big Health Inc.
Enrollment: 61
Locations: 1
Primary Endpoint: Environmental Reward Observation Scale (EROS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2023

End Date

December 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Big Health Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Environmental Reward Observation Scale (EROS)

Time Frame: 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

Patient Health Questionnaire (PHQ-8)

Time Frame: 5 weeks post-randomization

Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity

Secondary Outcomes

Patient Health Questionnaire (PHQ-8)(10 weeks post-randomization)
Montgomery-Åsberg Depression Rating Scale (MADRS)(5 and 10 weeks post-randomization)
World Health Organization 5-item Wellbeing Index (WHO-5)(Weeks 5 and 10 post-randomization)
Environmental Reward Observation Scale (EROS)(10 weeks post-randomization)