Rise Study for Depression

Sponsor

Big Health Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06003361

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Digital CBT Other: Waitlist	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

RCT of a Digital CBT Program for Major Depression in Adults

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient Health Questionnaire (PHQ-8) [5 weeks post-randomization]
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Environmental Reward Observation Scale (EROS) [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

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-8) [10 weeks post-randomization]
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Montgomery-Åsberg Depression Rating Scale (MADRS) [5 and 10 weeks post-randomization]
A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity
World Health Organization 5-item Wellbeing Index (WHO-5) [Weeks 5 and 10 post-randomization]
Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing
Environmental Reward Observation Scale (EROS) [10 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Big Health Inc.	San Francisco	California	United States	94108

Sponsors and Collaborators

Big Health Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Big Health Inc.

ClinicalTrials.gov Identifier:

NCT06003361

Other Study ID Numbers:

BH-D-02

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Aug 21, 2023