Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524598
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Limbix Health, Inc.

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).

Condition or disease Intervention/treatment Phase
Depression Device: Limbix Spark Other: Psychoeducation Not Applicable

Detailed Description:

Depression in adolescence is a public health crisis, with incidence and suicide rates rising sharply over the past decade. The COVID-19 global pandemic, along with mandated social and physical distancing, is expected to have substantial repercussions on public mental health and exacerbate the mental health crisis among teens. Adolescents, a group with significant unmet mental health needs, are at risk during this time, as they are especially vulnerable to depression and suicidality following environmental stressors, trauma, and social isolation that are endemic to this global pandemic. With difficulties in receiving in person care magnified during social distancing, now more than ever, there is an immediate need for safe, accessible, and effective digital treatments for mental health disorders.

The proposed intervention is intended to increase access to mental health care during the COVID-19 pandemic. This study aims to evaluate the clinical effectiveness and safety of a cognitive behavioral therapy (CBT)- based digital treatment for adolescent depression (Limbix Spark) relative to psychoeducation. Limbix Spark implements behavioral activation (BA), a key CBT skill that provides a sense of pleasure or mastery through self-monitored activities to reduce depressive symptoms and improve functional outcomes.

Adolescents with depression (13-21 years old) across the country will be recruited to participate in a fully remote, clinical trial via https://www.limbix.com/spark. At an initial virtual visit, following informed consent, adolescents and parents (for those under 18) will fill out standardized questionnaires designed to measure symptoms of depression, anxiety, and general health. Participants will then download an app onto their mobile phone and be randomly assigned to one of two groups. One group will receive the Limbix Spark program and the other will receive the Psychoeducation program for 5 weeks. The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and behavioral activation, and interactive activities including mood tracking and activity scheduling. The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression. During both 5 week programs, patients will also complete a weekly Patient Health Questionnaire, which is designed to measure depressive symptoms and also will report any negative side effects they may be experiencing. After 5 weeks, participants and legal guardians (for those under 18) will complete another set of standardized questionnaires designed to measure symptoms of depression, anxiety, and general health. Patients will also complete questionnaires asking them about their thoughts and experiences with the program they just completed. Lastly, a subset of patients and parents will be invited to complete a virtual interview to provide feedback on using the program.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Limbix Spark: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Limbix Spark
A 5 week program, focused on behavioral activation, a key CBT skill that provides a sense of pleasure or mastery through self-monitored activities to reduce depressive symptoms and improve functional outcomes.
Device: Limbix Spark
The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and behavioral activation, and interactive activities including mood tracking and activity scheduling.

Active Comparator: Psychoeducation
5 weeks of psychoeducation about depression based on the content of the NIMH Teenage Depression e-book and supplemented with content from publicly available government sponsored websites.
Other: Psychoeducation
The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.




Primary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]
    Change in depressive symptoms measured by Personal Health Questionnaire (PHQ-8) (min: 0; max: 24, with higher score indicating more severe depression).


Secondary Outcome Measures :
  1. Change in anxiety symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]
    Change in anxiety symptoms measured by the Generalized Anxiety Disorder (GAD-7) scale (min: 0; max: 21, with higher score indicating more severe anxiety).

  2. Change in parent report of child depressive symptoms [ Time Frame: Change from Baseline to Post treatment (5 weeks) ]
    Change in parent report of child depressive symptoms measured by the Mood and Feelings Questionnaire (MFQ) (min: 0; max: 26, with higher score indicating more severe depression)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524598


Contacts
Layout table for location contacts
Contact: Jessica Lake, PhD 888-546-2495 ext 708 jessica@limbix.com
Contact: Aarthi Padmanabhan, PhD 888-546-2495 ext 703 aarthi@limbix.com

Locations
Layout table for location information
United States, California
Limbix Health, Inc. Recruiting
San Francisco, California, United States, 94104
Contact: Jessica Lake, PhD    888-546-2495 ext 708    jessica@limbix.com   
Contact: Aarthi Padmanabhan, PhD    888-546-2495 ext 703    aarthi@limbix.com   
Sponsors and Collaborators
Limbix Health, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jessica Lake, PhD Director of Research
Principal Investigator: Aarthi Padmanabhan, Phd Research Director
Principal Investigator: Marisa Cruz, MD Chief Medical Officer
Additional Information:
Layout table for additonal information
Responsible Party: Limbix Health, Inc.
ClinicalTrials.gov Identifier: NCT04524598    
Other Study ID Numbers: Limbix Spark 02
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Limbix Health, Inc.:
Adolescence
Digital Therapeutic
Cognitive Behavioral Therapy
Behavioral Activation
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders