NCT06003361

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

August 15, 2023

Last Update Submit

January 12, 2024

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Digital CBT

EXPERIMENTAL

digitally-delivered CBT for depression accessed via mobile app

Device: Digital CBT

Waitlist

OTHER

Participants will wait for 5 weeks prior to receiving the intervention

Other: Waitlist

Interventions

Digital CBTDEVICE

An app-based intervention based on principles from cognitive behavioral therapy for depression.

Digital CBT
WaitlistOTHER

Participants will wait for 5 weeks prior to receiving the intervention

Waitlist

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Big Health Inc.

San Francisco, California, 94108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 21, 2023

Study Start

August 31, 2023

Primary Completion

November 22, 2023

Study Completion

December 21, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)