Clinical trial NCT04524598: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Official title: Limbix Spark: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Adolescence
Digital Therapeutic
Cognitive Behavioral Therapy
Behavioral Activation
Lead sponsor: Limbix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 227
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

The trial will be divided into two phases. The first phase will enroll 60 participants and participants will be randomized to either Spark and Control groups as described above. The second phase will enroll 175 participants and those randomized into the control group will be given access to the 5-week Spark intervention after completing the 5 weeks of control condition (control extension arm). Once completing the control extension arm, participants will complete a second set of post study questionnaires after 5 weeks.

All study participants that complete the 5-week Limbix Spark program and the post study questionnaires will be contacted and asked to consent to participation in the follow-up study. Only participants who did not opt-out to being contacted for future research will be contacted. This study will collect questionnaires from participants at any or all of the following time frames as indicated: 1-month, 3-month, and 6-month following completion of the Spark arm.

Eligibility 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

Primary outcomes:
measure: Phase I - Feasibility (Eligibility)
timeFrame: Pre-enrollment
measure: Number of Participants With Willingness to Participate and Program Adherence
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Phase I - Feasibility (Satisfaction)
timeFrame: Post-Treatment -"Week 5"
measure: Phase I - Feasibility (Safety)
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Phase II - Change in Depressive Symptoms
timeFrame: Change from Baseline to Post treatment (5 weeks)
Secondary outcomes:
measure: Phase I - Change in Depression Symptoms
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Number of Participants in Remission
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Change in Participant-rated Anxiety Symptoms and Global Functioning
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Change in Parent-reported Depressive Symptoms and Global Functioning.
timeFrame: From Baseline to Post Treatment (Week 5)
measure: Average Treatment-related Usability and Engagement Ratings
timeFrame: Post-Treatment
measure: Phase II - Safety
timeFrame: From Baseline to Post Treatment (Week 5)
measure: App Engagement and Adherence
timeFrame: From Baseline to Post Treatment (Week 5)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Limbix Health, Inc.
state: California
Study officials:
affiliation: Director of Research
name: Jessica Lake, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Director
name: Aarthi Padmanabhan, Phd
role: PRINCIPAL_INVESTIGATOR
References: