Rise Study for Depression

NCT ID: NCT06003361

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2023-12-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital CBT

digitally-delivered CBT for depression accessed via mobile app

Group Type EXPERIMENTAL

Digital CBT

Intervention Type DEVICE

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

Waitlist

Participants will wait for 5 weeks prior to receiving the intervention

Group Type OTHER

Waitlist

Intervention Type OTHER

Participants will wait for 5 weeks prior to receiving the intervention

Interventions

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Digital CBT

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

Intervention Type DEVICE

Waitlist

Participants will wait for 5 weeks prior to receiving the intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Big Health Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Big Health Inc.

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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BH-D-02

Identifier Type: -

Identifier Source: org_study_id

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