NCT06003361Completed
Rise Study for Depression
Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
Source: ClinicalTrials.gov · Last updated 17 Jan 2024
Brief summary (registry, in English)
This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 15 Aug 2023
- Start date
- 31 Aug 2023
- Primary completion date
- 22 Nov 2023
- Lead sponsor
- Big Health Inc.
- Diseases
- Depression
- NCT number
- NCT06003361
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 31 Aug 2023 to the primary completion date, 22 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Past or present psychosis, schizophrenia, or bipolar disorder
- 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
- Moderate or greater suicide risk
- Treatment-resistant depression
- Other exclusion criteria may apply
Who the study is looking for
- 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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Big Health Inc. Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.