N/A
N=60
A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19
Depression
Bottom Line
View on ClinicalTrials.gov: NCT04524598 ↗Enrolled (actual)
60
Serious AEs
0.9%
Results posted
Dec 2021
Primary outcome: Primary: Phase I - Feasibility (Eligibility) — 35; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Limbix Spark (Device); Psychoeducation (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Limbix Health, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I - Feasibility (Eligibility) |
35; 25 | — |
| PRIMARY Number of Participants With Willingness to Participate and Program Adherence |
35; 25; 8 | — |
| PRIMARY Phase I - Feasibility (Satisfaction) |
5.08; 1.78; 6.79; 3.94 | — |
| PRIMARY Phase I - Feasibility (Safety) |
0; 0; 0; 2; 0; 0 | — |
| PRIMARY Phase II - Change in Depressive Symptoms |
-5.08; -3.51 | 0.06 |
| SECONDARY Phase I - Change in Depression Symptoms |
-3.89; -3.34 | — |
| SECONDARY Number of Participants in Remission |
13; 7; 11; 2 | — |
| SECONDARY Change in Participant-rated Anxiety Symptoms and Global Functioning |
-2.87; -2.29; -3.21; -1.45; 1.13; -0.14 | 0.23 |
| SECONDARY Change in Parent-reported Depressive Symptoms and Global Functioning. |
-4.20; -4.88; -4.83; -2.85; 0.70; 0.88 | 0.33 |
| SECONDARY Average Treatment-related Usability and Engagement Ratings |
80.67; 75.83; 82.85; 76.12; 3.62; 3.10 | — |
| SECONDARY Phase II - Safety |
4; 2; 0; 0; 0; 0 | — |
| SECONDARY App Engagement and Adherence |
2.74; 3.17 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04524598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.