A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19

NCT04524598 | Completed Results FDA Device

• 1 other identifier: Limbix Spark 02
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).

Conditions

Depression

Keywords

Adolescence; Digital Therapeutic; Cognitive Behavioral Therapy; Behavioral Activation

Outcome Measures

Primary Outcomes (5)

• Phase I - Feasibility (Eligibility)

  Descriptive report of participant eligibility. Percentage of people who enrolled in each arm after expressing interest in participating in the study. Phase I participant arms are reported for this outcome.

  Pre-enrollment

• Number of Participants With Willingness to Participate and Program Adherence

  Descriptive report of willingness to participate and program adherence. Phase I participant arms are reported for this outcome.

  From Baseline to Post Treatment (Week 5)

• Phase I - Feasibility (Satisfaction)

  Descriptive report of participant satisfaction (mood improvement and enjoyment) on a scale of 0-10, with 0 meaning lower satisfaction and 10 meaning higher satisfaction. Phase I participant arms are reported for this outcome.

  Post-Treatment -"Week 5"

• Phase I - Feasibility (Safety)

  Descriptive report of participant safety. Phase I participant arms are reported for this outcome.

  From Baseline to Post Treatment (Week 5)

• Phase II - Change in Depressive Symptoms

  Between-subjects treatment-related change in depressive symptoms from baseline to 5-weeks as measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression) for those with baseline PHQ-8 ≥10.

  Change from Baseline to Post treatment (5 weeks)

Secondary Outcomes (7)

• Phase I - Change in Depression Symptoms

  From Baseline to Post Treatment (Week 5)

• Number of Participants in Remission

  From Baseline to Post Treatment (Week 5)

• Change in Participant-rated Anxiety Symptoms and Global Functioning

  From Baseline to Post Treatment (Week 5)

• Change in Parent-reported Depressive Symptoms and Global Functioning.

  From Baseline to Post Treatment (Week 5)

• Average Treatment-related Usability and Engagement Ratings

  Post-Treatment

Study Arms (2)

Limbix Spark

EXPERIMENTAL

A 5 week CBT-based intervention

Device: Limbix Spark

Psychoeducation

ACTIVE COMPARATOR

5 weeks of psychoeducation about depression. Upon completion, participants will be automatically enrolled into the Limbix Spark CBT-based intervention

Other: Psychoeducation

Interventions

Limbix Spark DEVICE

The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.

Limbix Spark

Psychoeducation OTHER

The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.

Psychoeducation

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 13 and 21
• Self-reported symptoms of depression
• Will be residing in the USA for the duration of the 5-week study
• Under the care of a US-based primary care and/or licensed mental healthcare provider and willing and able to provide the name and contact information of the provider during consent appointment.
• English fluency and literacy of adolescent and consenting legal guardian if under 18
• Access to a smartphone (iPhone 5s or later or running Android 4.4 KitKat or later) and regular internet access
• Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e-consent if under 18.

You may not qualify if:

• Self-reported lifetime suicide attempt or active self-harm or active suicidal ideation with intent
• Have a diagnosis by a clinician of bipolar disorder, substance use disorder, or any psychotic disorder including schizophrenia
• Incapable of understanding or completing study procedures and digital intervention as determined by participant, patient/legal guardian, healthcare provider, or clinical research team

Sponsors & Collaborators

• Limbix Health, Inc.: lead

Study Sites (1)

Limbix Health, Inc.

San Francisco, California, 94104, United States

Location

Related Publications (2)

• Peake E, Miller I, Flannery J, Chen L, Lake J, Padmanabhan A. Preliminary Efficacy of a Digital Intervention for Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 7;26:e48467. doi: 10.2196/48467.

  PMID: 38324367 DERIVED

• Kulikov VN, Crosthwaite PC, Hall SA, Flannery JE, Strauss GS, Vierra EM, Koepsell XL, Lake JI, Padmanabhan A. A CBT-based mobile intervention as an adjunct treatment for adolescents with symptoms of depression: a virtual randomized controlled feasibility trial. Front Digit Health. 2023 May 23;5:1062471. doi: 10.3389/fdgth.2023.1062471. eCollection 2023.

  PMID: 37323125 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Janel Shelton-DeMagnus, Research Operations Manager
• Organization: Limbix Health

janel@limbix.com

8885462495

Study Officials

• Jessica Lake, PhD

  Director of Research

  PRINCIPAL INVESTIGATOR

• Aarthi Padmanabhan, Phd

  Research Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: July 20, 2020
• Primary Completion: September 3, 2021
• Study Completion: January 16, 2022
• Last Updated: May 18, 2023
• Results First Posted: December 13, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)