Rise Study for Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003361
• Other study ID #: BH-D-02
• Status: Completed
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2024
• Source: Big Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 21, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Big Health Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Big Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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