Major Depressive DisorderNCT06028984
Self-guided Treatment for Depression
A study testing Intervention app 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 and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Intervention app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to Sep 2025
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive self report screen for depression
- Participant is at least 13 years of age
- Willing and able to provide informed consent; if under 18 years of age, willing and able to provide assent, and has a legal guardian willing and able to provide consent
- Primary diagnosis of Major Depressive Disorder (MDD)
- Under the care of a United States (U.S.)-based licensed healthcare provider and willing and able to provide contact information for the provider and sign a HIPAA release that allows investigator to contact provider
- Fluent and literate in English
- Has access to a compatible device and operating system (i.e., capable of installing the app from the Google Play or Apple App Store) and regular internet access
- Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the primary study period
Who cannot join
- Has changed or initiated psychotherapy with a mental health professional within 30 days prior to eligibility screening
- Has received certain types of psychotherapy within the last 6 months
- Has changed prescribed psychotropic medication (initiation or change in dose) within the past 30 days
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during study intervention period
- Suicidal behavior within the past year
- Active suicide ideation with intent within the past 3 months
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- Previously participated in user testing or a clinical study at Limbix Health Inc. or Big Health Inc. (such as the STAND study or Rise study), or have used a Limbix app
- Participated in any other clinical research involving an intervention or treatment within the past 60 days
- Plans to participate in any other clinical research involving an intervention or treatment during the study intervention period
- Living in the same household as another participant in the study (e.g., a sibling)
- Has a diagnosis of MDD with psychotic features or comorbid Psychotic Disorder
- Has a concurrent diagnosis of (or has been treated for) bipolar disorder I and II or severe substance use disorder within the past year
- Has treatment resistant depression
- Is employed by Big Health Inc., or is a collaborator, associate, or relation of Big Health Inc. staff
- Any condition, comorbidity, or event (other than the above) that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the intervention, or will prevent investigators from being able to ensure safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial
This study will examine the efficacy and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.
Read the detailed description
This study aims to examine the efficacy of a self-guided digital therapeutic app for depression compared to a control app in individuals aged 13 and older with a diagnosis of Major Depressive Disorder. The primary outcomes are patient- and clinician-reported depression symptom severity after 5 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- Intervention app, Control app
- Keywords
- Major Depressive Disorder, MDD, depression, digital therapeutic
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention appDevice
An app-based intervention for depression
Control appOther
An app with non-therapeutic content
| Study group | Role | What they receive |
|---|---|---|
| Intervention app | Experimental | Digitally-delivered self-guided intervention for depression accessed via mobile app Receives: Device: Intervention app |
| Control app | Active comparator | An app based control condition Receives: Other: Control app |
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
Montgomery-Åsberg Depression Rating Scale (MADRS)
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
Measured: 5 weeks post-randomization
Secondary outcomes (8)
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
5 point or greater reduction in PHQ-8 score from baseline
Measured: 5 weeks post-randomization, 1-month followup
Response based on the Patient Health Questionnaire (PHQ-8)
50% or greater reduction in PHQ-8 score from baseline
Measured: 5 weeks post-randomization, 1-month followup
Remission based on the Patient Health Questionnaire (PHQ-8)
PHQ-8 less than 5
Measured: 5 weeks post-randomization, 1-month followup
Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)
A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning
Measured: 5 weeks post-randomization, 1-month followup
Clinical Global Impression - Severity (CGI-S)
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms
Measured: 5-weeks post-randomization, 1-month followup
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
10 point or greater reduction in MADRS score from baseline
Measured: 5 weeks post-randomization, 1-month followup
Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Measured: 1-, 3- and 6-month followup
Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start12 Oct 2023
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Big Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028984
- Sponsor's protocol ID
- BH-SP-01
- Status last verified
- Apr 2024
- First submitted
- 29 Aug 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06028984
- Acronym / sponsor ID
- BH-SP-01
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, depression, digital therapeutic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Big Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University, National Institute of Mental Health (NIMH)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 8 Sep 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 and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.
Detailed description
This study aims to examine the efficacy of a self-guided digital therapeutic app for depression compared to a control app in individuals aged 13 and older with a diagnosis of Major Depressive Disorder. The primary outcomes are patient- and clinician-reported depression symptom severity after 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention app | Experimental | Device: Intervention appDigitally-delivered self-guided intervention for depression accessed via mobile app |
| Control app | Active comparator | Other: Control appAn app based control condition |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Positive self report screen for depression
- Participant is at least 13 years of age
- Willing and able to provide informed consent; if under 18 years of age, willing and able to provide assent, and has a legal guardian willing and able to provide consent
- Primary diagnosis of Major Depressive Disorder (MDD)
- Under the care of a United States (U.S.)-based licensed healthcare provider and willing and able to provide contact information for the provider and sign a HIPAA release that allows investigator to contact provider
Key exclusion criteria (15 listed)
- Has changed or initiated psychotherapy with a mental health professional within 30 days prior to eligibility screening
- Has received certain types of psychotherapy within the last 6 months
- Has changed prescribed psychotropic medication (initiation or change in dose) within the past 30 days
- Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during study intervention period
- Suicidal behavior within the past year
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 |
|---|---|---|
| Intervention appAn app-based intervention for depression | Device | Intervention app |
| Control appAn app with non-therapeutic content | Other | Control app |
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
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 5 weeks post-randomization
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
8 secondary outcomes
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
Time frame: 5 weeks post-randomization, 1-month followup
Response based on the Patient Health Questionnaire (PHQ-8)
Time frame: 5 weeks post-randomization, 1-month followup
Remission based on the Patient Health Questionnaire (PHQ-8)
Time frame: 5 weeks post-randomization, 1-month followup
Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: 5 weeks post-randomization, 1-month followup
Clinical Global Impression - Severity (CGI-S)
Time frame: 5-weeks post-randomization, 1-month followup
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
Time frame: 5 weeks post-randomization, 1-month followup
Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup
Time frame: 1-, 3- and 6-month followup
Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup
Time frame: 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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 Intervention app 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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Apr 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?
Results are not available in the source record.
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 5 Apr 2024.