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Rise Study for Depression

Primary Purpose

Major Depressive Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital CBT
Waitlist
Sponsored by
Big Health Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Big Health Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Digital CBT

Waitlist

Arm Description

digitally-delivered CBT for depression accessed via mobile app

Participants will wait for 5 weeks prior to receiving the intervention

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
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

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-8)
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)
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)
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)
A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities

Full Information

First Posted
August 15, 2023
Last Updated
October 11, 2023
Sponsor
Big Health Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06003361
Brief Title
Rise Study for Depression
Official Title
Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Big Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital CBT
Arm Type
Experimental
Arm Description
digitally-delivered CBT for depression accessed via mobile app
Arm Title
Waitlist
Arm Type
Other
Arm Description
Participants will wait for 5 weeks prior to receiving the intervention
Intervention Type
Device
Intervention Name(s)
Digital CBT
Intervention Description
An app-based intervention based on principles from cognitive behavioral therapy for depression.
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
Participants will wait for 5 weeks prior to receiving the intervention
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-8)
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time Frame
5 weeks post-randomization
Title
Environmental Reward Observation Scale (EROS)
Description
A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities
Time Frame
5 weeks post-randomization
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-8)
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time Frame
10 weeks post-randomization
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
A validated 10 item observer-rated scale with total scores between 0 and 60 where higher scores indicate greater severity
Time Frame
5 and 10 weeks post-randomization
Title
World Health Organization 5-item Wellbeing Index (WHO-5)
Description
Validated questionnaire; a 5-item scale with raw total scores between 0 and 25 where higher scores indicate greater wellbeing
Time Frame
Weeks 5 and 10 post-randomization
Title
Environmental Reward Observation Scale (EROS)
Description
A validated 10 item scale with total scores between 10 and 40 where higher scores indicate greater engagement with rewarding or fulfilling life activities
Time Frame
10 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Big Health Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rise Study for Depression

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