Self-guided Treatment for Adolescents Navigating Depression

NCT05462652 | Completed Results DMC FDA Device

• 1 other identifier: LMX-001
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible. Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.

Conditions

Depressive Symptoms; Depression; Depressive Disorder; Depressive Episode

Keywords

Mental Health; Adolescents; Depression; Adolescent Mental Health

Outcome Measures

Primary Outcomes (1)

• Depressive Symptom Severity at Post-intervention

  Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.

  Post-intervention (5 week timepoint)

Secondary Outcomes (3)

• Intervention Response at Post-intervention

  Change from baseline to post-intervention (5 weeks)

• Remission at Post-intervention

  Post-intervention (5 week timepoint)

• Clinically-meaningful Reduction in Severity at Post-intervention

  Change from baseline to post-intervention (5 weeks)

Study Arms (2)

Active Intervention

EXPERIMENTAL

The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.

Device: Active Intervention

Usual Care

NO INTERVENTION

UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.

Interventions

Active Intervention DEVICE

The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.

Active Intervention

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• PHQ-8 score ≥ 5 at eligibility screening
• English fluency and literacy (participant and legal guardian, if applicable)
• Access to a compatible smartphone (or other device) and operating system (i.e., capable of installing the app from the Google Play or Apple App Store; list will be provided on study website) and regular internet access
• Participant willing and able to provide informed consent/assent and have legal guardian willing and able to provide informed consent (if required)
• Under the care of a United States (U.S.)-based licensed healthcare provider and willing to provide contact information for the provider and sign a HIPAA release that allows Limbix to contact provider
• Willing and able to provide information required for study enrollment (e.g. all responses to initial PHQ-8 assessment, and current antidepressant medication status)
• Located in the continental U.S., Hawaii, or Alaska, and not planning to leave the U.S. during the study period (through 1-month follow up assessments, up to 11 weeks after eligibility screening)

You may not qualify if:

• Diagnosis of (or treatment for) bipolar disorder, post traumatic stress disorder, psychotic disorder, substance use disorder, or eating disorder within the 12 months prior to eligibility screening
• Change in psychotropic medication (initiation or change in dose) within the 30 days prior to eligibility screening
• Plans to initiate or change treatment (e.g., psychotherapy, psychotropic medication, and/or other psychosocial treatment) for a mental health disorder during the study intervention period (5 weeks) as determined at eligibility screening
• Suicide attempt within the past year
• Active suicide ideation with intent
• Previous participation in user testing or clinical testing of Spark or SparkRx, or other previous use of SparkRx app
• Participation in any other clinical research involving a mental health intervention or treatment within 60 days prior to eligibility screening
• Plans to participate in any other clinical research involving a mental health intervention or treatment during the study intervention period (5 weeks) as determined at eligibility screening
• Any condition, comorbidity, or event 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
• Having a sibling who is a past or current participant in the study

Sponsors & Collaborators

• Limbix Health, Inc.: lead

Study Sites (1)

Limbix Health, Inc.

San Francisco, California, 94104, United States

Location

Related Publications (1)

• Furman DJ, Hall SA, Avina C, Kulikov VN, Lake JI, Padmanabhan A. Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 16;12:e48740. doi: 10.2196/48740.

  PMID: 37971800 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Personal Satisfaction

Results Point of Contact

• Title: Jessica Lake
• Organization: Big Health, Inc.

research@bighealth.com

(510) 244-3753‬

Study Officials

• Aarthi Padmanabhan, PhD

  Limbix Health, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: July 28, 2022
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)