Self-guided Treatment for Adolescents Navigating Depression

NCT ID: NCT05462652

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2023-04-21

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.

Detailed Description

The primary aim of the proposed research is to evaluate the effectiveness of a self-guided, cognitive behavioral therapy (CBT)-based mobile app + assessment-enhanced Usual Care (eUC) compared to eUC alone as an intervention for adolescents with symptoms of depression who are under the supervision of a licensed healthcare provider.

The sample size for this study is 220 subjects. Sample size calculation is based on primary outcome patient health questionnaire (PHQ-8) at post-intervention (5 weeks). Six PHQ-8 measurements will be collected from each subject (baseline and weekly during the 5-week intervention period). Using a two-sample t-test approach, assuming a two-tailed alpha set at 0.05, a total of 200 participants (100 in each study arm) will give us 80% power to detect a moderate effect size of at least d=0.4. Given an anticipated 10% rate of attrition, we aim to enroll 220 total participants in the study.

A 50% female sample will be targeted. Earlier recruitment efforts within the study demographic have resulted in majority female samples, consistent with prevalence rates within the study population. As such, recruitment efforts will be undertaken to ensure representation of male participants. Recruitment efforts will be taken to ensure adequate representation of underrepresented racial and ethnic minority groups.

Children between the ages of 13-17 will be included in this research as the program to be evaluated is specifically designed as an intervention for adolescents with symptoms of depression. Assent will be obtained from all children under 18 for study enrollment unless legally emancipated or financially independent in accordance with CA state regulations and regulations of the state in which the minor resides.

Study staff will monitor participants' symptom deterioration and questionnaire data for safety.

Conditions

Depressive Symptoms; Depression; Depressive Disorder; Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Intervention

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.

Group Type: EXPERIMENTAL

Active Intervention

Intervention Type: 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.

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Active Intervention

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 13-21 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limbix Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aarthi Padmanabhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Limbix Health, Inc.

Locations

Limbix Health, Inc.

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37971800 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LMX-001

Identifier Type: -

Identifier Source: org_study_id