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Self-guided Treatment for Depression

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention app
Control app
Sponsored by
Big Health Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, depression, digital therapeutic

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Big Health, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention app

Control app

Arm Description

Digitally-delivered self-guided intervention for depression accessed via mobile app

An app based control condition

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-8)
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)
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity

Secondary Outcome Measures

Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
5 point or greater reduction in PHQ-8 score from baseline
Response based on the Patient Health Questionnaire (PHQ-8)
50% or greater reduction in PHQ-8 score from baseline
Remission based on the Patient Health Questionnaire (PHQ-8)
PHQ-8 less than 5
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
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
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
10 point or greater reduction in MADRS score from baseline
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
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

Full Information

First Posted
August 29, 2023
Last Updated
October 13, 2023
Sponsor
Big Health Inc.
Collaborators
Duke University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT06028984
Brief Title
Self-guided Treatment for Depression
Official Title
Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Big Health Inc.
Collaborators
Duke University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD, depression, digital therapeutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention app
Arm Type
Experimental
Arm Description
Digitally-delivered self-guided intervention for depression accessed via mobile app
Arm Title
Control app
Arm Type
Active Comparator
Arm Description
An app based control condition
Intervention Type
Device
Intervention Name(s)
Intervention app
Intervention Description
An app-based intervention for depression
Intervention Type
Other
Intervention Name(s)
Control app
Intervention Description
An app with non-therapeutic content
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-8)
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time Frame
5 weeks post-randomization
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
Time Frame
5 weeks post-randomization
Secondary Outcome Measure Information:
Title
Clinically important improvement based on the Patient Health Questionnaire (PHQ-8)
Description
5 point or greater reduction in PHQ-8 score from baseline
Time Frame
5 weeks post-randomization, 1-month followup
Title
Response based on the Patient Health Questionnaire (PHQ-8)
Description
50% or greater reduction in PHQ-8 score from baseline
Time Frame
5 weeks post-randomization, 1-month followup
Title
Remission based on the Patient Health Questionnaire (PHQ-8)
Description
PHQ-8 less than 5
Time Frame
5 weeks post-randomization, 1-month followup
Title
Global improvement assessed using the clinician-rated Clinical Global Impression Scale - Improvement (CGI-I)
Description
A single-item measure scored between 1 and 7 where lower scores indicate greater improvement in global functioning
Time Frame
5 weeks post-randomization, 1-month followup
Title
Clinical Global Impression - Severity (CGI-S)
Description
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Major Depressive Disorder Symptoms
Time Frame
5-weeks post-randomization, 1-month followup
Title
Clinically important improvement based on the Montgomery-Åsberg Depression Scale (MADRS)
Description
10 point or greater reduction in MADRS score from baseline
Time Frame
5 weeks post-randomization, 1-month followup
Title
Depression severity assessed with the Patient Health Questionnaire (PHQ-8) at followup
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time Frame
1-, 3- and 6-month followup
Title
Clinician-rated depression severity as measured by the Montgomery-Åsberg Depression Scale (MADRS) at followup
Description
Validated assessment: a 10-item scale based on clinical interview with total scores between 0 and 60 where higher scores indicate greater severity
Time Frame
1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniella Furman, PhD
Phone
510-244-3753
Email
daniella.furman@bighealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aarthi Padmanabhan, PhD
Email
aarthi.padmanabhan@bighealth.com
Facility Information:
Facility Name
Big Health, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella Furman, PhD
Email
daniella.furman@bighealth.com
First Name & Middle Initial & Last Name & Degree
Aarthi Padmanabhan, PhD
Email
aarthi.padmanabhan@bighealth.com
First Name & Middle Initial & Last Name & Degree
Aarthi Padmanabhan, PhD
First Name & Middle Initial & Last Name & Degree
Daniella Furman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-guided Treatment for Depression

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