Major Depressive DisorderNCT06003361
Rise Study for Depression
A study testing Digital CBT and Waitlist in people with Major Depressive Disorder, run by Big Health Inc. at 1 site in United States.
Trial summary
This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Digital CBT and Waitlist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Digital CBT, Waitlist
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital CBTDevice
An app-based intervention based on principles from cognitive behavioral therapy for depression.
WaitlistOther
Participants will wait for 5 weeks prior to receiving the intervention
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT | Experimental | digitally-delivered CBT for depression accessed via mobile app Receives: Device: Digital CBT |
| Waitlist | Other | Participants will wait for 5 weeks prior to receiving the intervention Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Measured: 5 weeks post-randomization
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
Measured: 5 weeks post-randomization
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Measured: 10 weeks post-randomization
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
Measured: 5 and 10 weeks post-randomization
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
Measured: Weeks 5 and 10 post-randomization
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
Measured: 10 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start31 Aug 2023
- Primary completion22 Nov 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Big Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003361
- Sponsor's protocol ID
- BH-D-02
- Status last verified
- Jan 2024
- First submitted
- 15 Aug 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
- ClinicalTrials.gov ID
- NCT06003361
- Acronym / sponsor ID
- BH-D-02
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Big Health Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital CBT | Experimental | Device: Digital CBTdigitally-delivered CBT for depression accessed via mobile app |
| Waitlist | Other | Other: WaitlistParticipants will wait for 5 weeks prior to receiving the intervention |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital CBTAn app-based intervention based on principles from cognitive behavioral therapy for depression. | Device | Digital CBT |
| WaitlistParticipants will wait for 5 weeks prior to receiving the intervention | Other | Waitlist |
Primary outcome
Patient Health Questionnaire (PHQ-8)
Time frame: 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)
Time frame: 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
4 secondary outcomes
Patient Health Questionnaire (PHQ-8)
Time frame: 10 weeks post-randomization
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 5 and 10 weeks post-randomization
World Health Organization 5-item Wellbeing Index (WHO-5)
Time frame: Weeks 5 and 10 post-randomization
Environmental Reward Observation Scale (EROS)
Time frame: 10 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Not yet recruiting
Sedation and Guided Education for Depression Study
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital CBT and Waitlist in people with Major Depressive Disorder, run by Big Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-8) (time frame: 5 weeks post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.